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M I S S I N G
P I E C E :
Implementation and
Impact of a Complex
Discharge Team
T H E O F F I C I A L P U B L I C AT I O N O F T H E A M E R I C A N C A S E M A N A G E M E N T A S S O C I AT I O N
FALL 2014 • VOLUME 11 • ISSUE 06
COLLABORATIVE
CASE MANAGEMENT
4 Implementation and Impact of a Complex
Discharge Team
Theresa Horowitz, MSW, LCSW, CTSBP
Jessica Soos Pawlowski, MA, LCSW, ACM
PUBLISHER
L. Greg Cunningham, MHA
CEO
ACMA / Little Rock, AR
[email protected]
EDITOR
Tyler Neese
Director, Public Policy and Communications
ACMA / Little Rock, AR
[email protected]
EDITORIAL BOARD
Reggie Allen, MBA, RN
System Director, Clinical Operations
CHRISTUS Health • Irving, TX
Paul Arias, RN, BSN, MIS
Clinical Services Head/Site Lead
ActiveHealth Management • Chantilly, VA
Frank B. Bellamy, RN, MSN, ACM
Interim Director, Case Management
Rockford Memorial Hospital • Rockford, IL
Colleen Booz Dittrich, LMSW, CCM
Manager, Case Management
The University of Kansas Hospital • Kansas City, KS
7 SWOT Analysis of Case Management Models
at Three Hospitals
Allen Gibson, LMSW
Joan Brueggeman, RN, BSN, CPUM
Clinical Manager, Utilization Management
and Care Coordination
Gundersen Health System • La Crosse, WI
Dani Hackner, MD
Medical Director, Case Management
Cedars-Sinai Medical Center • Los Angeles, CA
Timothy Morrison, LCSW, ACM
Director, Clinical Support Services
Stanford Hospital and Clinics • Stanford, CA
13 Form Over Substance: CMS Reconsiders
Certification Requirement for All Inpatient
Hospital Admissions
Jessica L. Gustafson, Esq.
Abby Pendleton, Esq.
16 Building the Foundation to Reduce
Readmissions for Heart Failure
Gail Serralta, RN, BSN, CCM, CMAC
Michelle Hendricks, RN, BSN
“Case management in hospital and health care systems is a collaborative practice model including
patients, nurses, social workers, physicians, other practitioners, caregivers and the community. The
case management process encompasses communication and facilitates care along a continuum
through effective resource coordination. The goals of case management include the achievement
of optimal health, access to care and appropriate utilization of resources, balanced with the
patient’s right to self-determination.”
Approved by ACMA membership, November 2002
Ann Scotti, LCSW, ACM
Director, Care Coordination
St. Peter’s University Hospital • New Brunswick, NJ
Nancy Sullivan, MBA, CMAC
Director, Case Management
Massachusetts General Hospital • Boston, MA
Collaborative Case Management is published
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Copyright © 2014 American Case Management
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WWW.ACMAWEB.ORG/CMWEEK
COLLABORATIVE CASE MANAGEMENT | ACMAWEB.ORG
Implementation and Impact of a
Complex Discharge Team
Theresa Horowitz, MSW, LCSW, CTSDP; Jessica Soos Pawlowski, MA, LCSW, ACM
THESE AUTHORS HAVE NO FINANCIAL RELATIONSHIPS WITH COMMERCIAL INTERESTS TO DISCLOSE.
Patients who present to the hospital
with complicated medical and
psychosocial situations often lead to
long lengths of stay, increased hospital
costs, and added frustration for the
patient, family, and staff. The
Northwestern Memorial Hospital
(NMH) Complex Discharge Team
(CDT) is a new model aimed at
proactively identifying and managing
cases that could result in an
unnecessarily long length of stay,
challenging placement or complicated
discharge. This article will examine
the development of a multidisciplinary
Complex Discharge Team, as well as
the early successes in improving
patient outcomes and reducing
unnecessary health care costs.
4
LEARNING OBJECTIVES
1. Identify three components of a successful
CDT program
2. Understand the processes and personnel
involved in identifying CDT cases and
designing interventions
3. Identify potential barriers to
implementing a CDT program
ABOUT NORTHWESTERN MEMORIAL
HOSPITAL (NMH)
NMH is a nationally ranked academic medical
center hospital located in downtown Chicago,
Illinois. It is the primary teaching hospital for
Northwestern University’s Feinberg School of
Medicine. Along with its Prentice Women’s
Hospital and Stone Institute of Psychiatry, the
hospital provides a total of 894 inpatient beds
and encompasses more than 3 million square
feet of medical building space.
EXAMINING THE NEED
The Complex Discharge Team (CDT) model
began in response to a troubling and prevalent
concern: In Fiscal Year 2009, Northwestern
Memorial Hospital patients spent over 6,000
avoidable days in the hospital due to discharge
barriers. A very few patients had long, frequent,
and unnecessary hospital stays that accounted
for a large percentage of these days. This
pattern was causing frustration for patients
and families as well as additional costs to the
hospital, without necessarily helping the
patient recover effectively.
The leadership team set out to provide a more
appropriate level of care in a more suitable
setting by addressing these challenging
FALL EDITION 2014
dynamics and discharge barriers. These
aforementioned data led to early discussions
about implementing an intervention team to
help improve discharge efficiency and patient
care. A Difficult Discharge Response Team
(DDRT) was created and existing staff began
making long length of stay rounds. The DRRT
evolved, and in June 2013, hospital
administrators approved a pilot for a dedicated
team – the CDT, which would allow for a team
separate from the floor staff focused on
complex discharges.
PROGRAM OVERVIEW
The program aims to proactively identify and
manage cases which could result in an
unnecessarily long stay or a challenging
transition out of hospital care. Patients who
may benefit from this type of case management
approach can include situations such as
individuals who are undocumented and have
significant medical needs; individuals who
have frequent hospital visits for issues related
to substance abuse or lack of resources such
as food and shelter limiting their ability to care
for themselves independently and individuals
with complex support systems which prevent
a safe discharge plan. The initial goals of the
CDT implementation were threefold:
1.Create a structured process and involve
key stakeholders in the development of
the program.
2.Improve the patient experience by
providing a continuum of care.
3.Develop a cost effective way to manage
complex patients.
THE STRUCTURE OF THE TEAM
The team is structured to allow four dedicated
hospital staff members, with support from a
larger network, to comprise the core CDT. A
social worker is the lead for managing each
individual case and also provides clinical
consultation to hospital staff regarding complex
cases. The social worker is involved in
interdisciplinary treatment teams, discharge
planning, case management and community
networking. A medical director provides
consultation, helps to provide care plans and
liaises with attending MDs and medical teams.
A psychiatry fellow is involved in determining
decision-making capacity, identifying
psychiatric issues and assessing potential
discharge destinations. Finally, a clinical
practice manager is available to approve
smaller financial commitments, liaise to the
Executive Committee and help with creative
problem solving.
Ad hoc members of the CDT include
representatives from the legal and ethics
departments, who provide consultation as
needed. An Executive Committee was put in
place to assist the team in reviewing cases and
approving larger financial commitments or
other unique interventions. The Executive
Committee includes the vice president of
operations for nursing, the vice president of
finance and revenue and the senior attorney
for the office of general counsel.
The caseload for dedicated CDT staff is
necessarily lower than average due to the level
of complexity and time-intensive situations.
The social worker on the CDT generally sees
about 5-10 patients per day and performs about
15-20 consults.
As the hospital is a large academic medical
center there are advantages when it comes to
addressing complex discharges. The ability to
have four dedicated staff members means if
the social worker requires further assistance
on a case, she has three other professionals at
her immediate disposal and several others
throughout the hospital who can consult in to
assist with care progression. This structure,
which utilizes the strengths and attention of a
variety of hospital staff throughout the
organization, has been critical to the success
of the CDT.
The ability to justify and obtain additional
resources for this need could be a challenge at
smaller or less connected institutions. Hard
data has been valuable evidence for the NMH
team to demonstrate the importance of the
CDT. The data has highlighted the number of
avoidable days patients were spending in the
hospital, as well as the high-risk factors for
these patients and situations. This provided
necessary evidence to validate the risk and
benefit of these interventions in working with
complex cases.
INTERVENTIONS
There are two primary methods used at NMH
to identify cases for CDT intervention.
1- The case is presented to CDT by inpatient
hospital staff, which is most often characterized
by the social worker assessing patients in the
unit. He or she reaches out to CDT for clinical
consultation on a case-by-case basis.
2- A daily report generated in the hospital’s
in-house database, based on specific input
criteria. CDT staff considers patients who meet
any of the following criteria:
• Admitted for seven or more days
• Under observation for three or more days
• Unusually high number of inpatient
encounters in the past year
• History of severe behavioral issues
• No insurance or is underinsured
The CDT works with patients, families and
external partners to leverage options and to
problem solve around complex discharges.
This can involve a wide variety of interventions.
For example, the CDT sometimes works to
navigate legal relationships to resolve
guardianship issues. They help to repatriate
patients from abroad who would be better
served medically and psychosocially in their
home countries. They have even paid rent for
patients who need a safe place to receive
consistent home treatments.
Although absorbing these upfront costs and
dedicating so much time to a relatively small
number of discharges might appear
counterintuitive, the data shows marked
improvement in patient outcomes and substantial
financial savings to the hospital overall.
EARLY SUCCESS
From the beginning of the pilot in June 2013
to present, CDT has identified and managed
197 cases. During this time, the team reduced
the average length of stay for these patients
from 86.9 days in 2012 to 17.4 days in 2013.
The average avoidable days per patient was
reduced from 55 to 4.2, showing drastic
reductions in unnecessary stays.
Significant savings for the hospital were
identified and a conservative estimate suggests
with the 197 CDT cases to date, CDT has saved
the hospital $996,500 and 1,993 bed-days. Not
only does this improve the hospital’s financial
resources, this frees-up valuable time and
attention for inpatient medical staff to provide
care more effectively and to more patients.
To date, the total investment in CDT cases
has been approximately $397,000 compared
to the estimated $996,500 in savings. However,
the highest costs almost always arise from the
most complex and unusual cases; in fact, 80
percent of those costs were from just six cases.
Despite the high investment in those cases,
considerable savings still occurred. For
example, weeks of daily planning combined
with absorbing the cost of an international air
ambulance to Central Asia saved over six
5
COLLABORATIVE CASE MANAGEMENT | ACMAWEB.ORG
months of otherwise unavoidable days.
Over 73 percent of CDT cases require no
additional financial commitment from the
hospital. In fact, only 7 percent of cases cost
the hospital over $3,000. Most cases required
only strategic planning and creative problem
solving can resolve many challenging discharge
barriers. To date, only eight cases have needed
to be escalated to the Executive Committee.
Early, informal feedback from patients and
families has been overwhelmingly positive.
Patients reported higher satisfaction with their
hospital stay and discharge plan. Additionally,
ongoing feedback from physicians, nurses and
interdisciplinary team members has been
positive. The CDT implementation has
promoted teamwork and increased morale for
the staff throughout the hospital who work
with complex patient situations. This model
has also created a more standardized method
of communication and has provided resources
across disciplines to keep everyone accountable
for timely and appropriate discharges.
The CDT has required a significant culture
shift at the hospital, especially for executives
in recognizing how high upfront costs provide
both overall cost savings and happier, healthier
patients. Investing in patient care even outside
of the hospital setting provides long-term
benefits and cost savings to all parties.
FUTURE IMPROVEMENTS
Despite excellent early outcomes,
opportunities remain to improve the
CDT program:
1. External partnerships. This will allow the
ability to expand options and increase
efficiency in providing services in the
community. Several area nursing homes,
home health agencies and air ambulance
6
providers have already identified an
interest in expanding a partnership with
the CDT in order to further meet the needs
of mutual patients.
2.Data analysis and formal feedback. The
team would like to develop additional
metrics which can be tracked in the
system. This will allow providers and the
hospital to more accurately and efficiently
identify dollars saved and avoidable days
in the system.
3.Ongoing monitoring of patients. The team
would like the ability to easily identify
patients in the system who have had a
CDT intervention in the past. This would
further support the overall efficiency in
early interventions and allow for
continuity of care.
4.Expansion of program. The team would
also like to expand to create long term
plans for patients who have frequent
readmissions to assist in improving their
continuum of care plan beyond
the hospitalization.
SUMMARY
Early intervention makes a significant
difference in the ability to effectively and
efficiently treat patients with potentially
complex discharges and to impact what
could otherwise be a lengthy stay in the
hospital system.
Although the CDT has only formally existed
since June 2013, the early results are very
promising and the buy-in from hospital
administrators and inpatient medical
professionals is strong. The team is encouraged
by this success and looks forward to improving
and expanding the role of the CDT.
ABOUT THE AUTHORS
Theresa Horowitz, MSW, LCSW,
CTSDP, is a Social Work Clinical Leader at
Northwestern Memorial Hospital.
She has been the Complex Discharge Team
Social Worker since the fall of 2013
and employed as an inpatient Social Worker
at the hospital since 2012. She earned her
MSW from Washington University in
St. Louis, MO, and a BA in Psychology from
Kalamazoo College in Kalamazoo, MI. She has
10 years of experience in direct practice with
mental health and health care,
with expertise in crisis management,
solution-focused therapy, severe mental
illnesses, diverse populations and trauma. She
is also an Adjunct Professor of Psychology at
Harrington College of Design in Chicago, IL,
where she teaches undergraduate
psychology courses.
Jessica Soos Pawlowski, MA, LCSW,
ACM, has worked at Northwestern Memorial
Hospital since 1999, when she served
in General Medicine and outpatient HIV/ID
clinic Social Work roles. She became the
Manager in the Department of
Case Management in 2009 before
transitioning to her current role as Social
Work Practice Manager/Social Work HUB
Manager in 2012. She received her BSW
from Indiana University, and her MA from
the School of Social Service Administration,
University of Chicago. During her tenure
at Northwestern Memorial Hospital, she
has also held positions with the Midwest AIDS
Teaching and Education Center, Loyola
Medical Center, and the University of Chicago,
where she has been a Field Consultant/
Seminar Instructor for the graduate Extended
Evening Program since 2007.
FALL EDITION 2014
SWOT Analysis of Case Management Models at
Three Hospitals
Allen Gibson, LMSW
THIS AUTHOR HAS NO FINANCIAL RELATIONSHIPS WITH COMMERCIAL INTERESTS TO DISCLOSE.
As a fellow in medical social work case
management, I gained valuable
experience in the design and
implementation of case management
delivery systems in widely varying
hospitals. This article will examine the
similarities and differences of the case
management systems at those
hospitals –Memorial Hermann
Healthcare System, Cleveland Clinic,
and the University of Texas MD
Anderson Cancer Center – to draw
conclusions about the strengths,
weaknesses, opportunities, and threats
to providing high-quality, efficient
patient care and case management.
LEARNING OBJECTIVES
1. Identify different models for case
management within varying
hospital settings
2. Explain how different aspects of
case management implementation
could benefit or hinder a
particular environment
3. Identify the role of a dedicated
utilization manager and the benefits
and drawbacks of that approach
Over the course of a nine-month hospital
case management fellowship, sponsored
by the American Case Management
Association, I was able to work with the
case management departments at three
different health systems to gain experience
in different areas of medical social work
case management. I worked at Memorial
Hermann Healthcare System – the host
site for the fellowship, while also spending
time at Cleveland Clinic and The University
of Texas MD Anderson Cancer Center, to
explore different case management
delivery systems and undertake a
comparative study of hospital case
management models.
BACKGROUND
Memorial Hermann is the largest not-forprofit health system in Southeast Texas.
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COLLABORATIVE CASE MANAGEMENT | ACMAWEB.ORG
The system includes 12 acute care hospitals,
seven cancer centers, and a variety of
outpatient services.
During my time within Memorial Hermann’s
care management department I had
numerous opportunities to shadow
professionals from multiple service areas
within the system. I began my fellowship
working with the community outreach for
personal empowerment (COPE) program,
which is an ambulatory social work program
with the goal of helping uninsured patients
locate and utilize primary health care
resources in the community. This program
utilizes three social workers who serve each
of Memorial Hermann’s nine acute care
hospitals, focusing on patients who are
uninsured and present to Memorial Hermann
locations three or more times in one year.
The COPE program helps to address the
growing population of uninsured patients
within the greater Houston community that
numbered 1.1 million as of 2010, which is
approximately the population of Dallas, TX.
Through this experience I was able to learn
about the community resources available in
the city and acclimate to the hospital social
work case management environment. By the
end of this rotation I was carrying a full
caseload of three acute care hospitals’.
Following the COPE rotation, I spent several
weeks working within The Institute for
Rehabilitation and Research (TIRR), an acute
inpatient rehab hospital located in the Texas
Medical Center, specializing in spinal cord
injury and traumatic brain injury
rehabilitation and recovery. I shadowed social
workers and case managers working with
patients on the floor, learning more about
post-acute services available to patients while
gaining perspective on how case
management functions at different levels in
the health care continuum.
I was also able to shadow case management
professionals from the hospital’s System
Services Case Management Team, which
reviews all claim payment denials on Medicare
patients from the Recovery Auditors (RACs)
and the Medicare Administrative Contractors
(MACs). Based on the analysis of denied
claim causes, process improvement action
plans are created. Through this experience I
was able to gain insight into the role of
utilization management and the denial
management process.
8
My final rotation was spent shadowing social
work professionals on the floor within Memorial
Hermann’s acute care facilities.
I was exposed to case management in many
different settings, including Katy Hospital, a
small suburban community hospital, Northwest
Hospital, fast-paced and urban, and Memorial
City Hospital, a large suburban medical center.
Here, I continued shadowing social workers on
the floor and began to carry a modified caseload,
operating independently with support from the
floor social workers.My first site visit occurred
at Cleveland Clinic, a nonprofit health system
in Cleveland, Ohio. Cleveland Clinic cares for
patients from more than 100 countries and has
locations in multiple states and abroad.
As part of the fellowship, I was given the
opportunity to spend a week shadowing and
interviewing professionals within Cleveland
Clinic’s case management department. I spent
three days working at the main campus,
shadowing professionals from multiple service
areas, including cardiology, psych consult liaison,
inpatient and outpatient oncology, palliative
medicine, organ transplant and pediatrics. In
addition to this, I was able to interview various
administrators to learn more about Cleveland
Clinic and its case management program.
The last site that I visited was MD Anderson
Cancer Center, a public nonprofit hospital.
MD Anderson conducts more clinical trials for
cancer treatment than any other hospital system,
ranks first in total amount of grant dollars from
the National Cancer Institute and is host to the
largest stem cell transplant center in the world.
MD Anderson works on a cost-based
reimbursement system, due to its status as a
public hospital.
COMPARISON
As part of my fellowship I was tasked with
comparing the case management programs
operated by Memorial Hermann, Cleveland
Clinic and MD Anderson. Within these
systems, the scope of case management is
largely similar. In general, case managers are
responsible for utilization management, care
facilitation and discharge planning, while
social workers are responsible for issues
including complex discharge planning,
psychosocial assessment and intervention,
and legal issues such as custody and advance
directives. There are some small differences
to the models, but each system largely
operates in this fashion.
Fellowship Experiences
Community Outreach for Personal
Empowerment (COPE)
• Ambulatory social work program with
the goal of helping uninsured patients
to locate and utilize primary healthcare
resources in the community
• 1.1 million uninsured patients in
Greater Houston, which is
approximately the population of
Dallas, TX
The Institute for Rehabilitation and
Research (TIRR)
• Acute Inpatient Rehab hospital
located in the Texas Medical Center,
specializing in spinal cord injury
and traumatic brain injury
rehabilitation and recovery
• TIRR service line also includes all
hospital-based comprehensive
inpatient rehab units.
Two weeks at Katy Hospital (C)
• Small suburban communityhospital
(142 beds) in Houston’s fastest
growing community
Three weeks at Northwest Hospital (F)
• Fast-paced urban hospital (200
beds) in Houston’s oldest and most
popular neighborhood
• Gained exposure to med/surg and
internal medicine environments
Six weeks at Memorial City Hospital (K)
• Large suburban medical center (375
beds), Memorial Hermann’s system
headquarters
• Gained exposure to ICU, IMU,
Cardiology and Oncology environments
One week with Memorial Hermann’s
RAC review team (K)
• System Services Case Management
team working with the RAC/MAC
to prevent loss due to Medicare
claims through denial management
• Shadowed case managers to gain
insight into the role of utilization
management and completed a few
basic total joint reviews
FALL EDITION 2014
DYAD MODEL
Strengths
TRIAD MODEL
Strengths
•Increases
operational
efficiency by
consolidating
roles and
responsibilities
• Ensures that
each case
management
role receives
sufficient
attention
Weaknesses
Weaknesses
• Forces case
managers to reprioritize roles
based on the
patient’s needs • Could result in a
fragmented care
team
Opportunities
Opportunities
• Potential for
improved patient
care outcomes due
to a decrease in
the number of
hand-offs
• Potential to
ensure that
patient needs
and payer rules
are adequately
addressed
Threats
Threats
• Lack of compliance
with payer rules
will affect
reimbursement
• Potential for
pitfalls with
patient handoffs
• Lack of focus in
any one role can
result in
readmissions,
higher cost per
case, and quality
concerns
Two primary models are used for case
management within these systems. In a dyad
model (used at Memorial Hermann and MD
Anderson), the utilization management
responsibility is retained within the role of the
case manager. In a triad model (utilized at
Cleveland Clinic), the utilization management
responsibility is broken off into a separate
professional role.
In addition to this, each system had similar
standards for staffing within these departments.
Each system has minor differences, but all
models require RN licensure and case
management certification upon availability for
nursing and master’s level education for social
workers. One notable difference is that while
both MD Anderson and Cleveland Clinic accept
both social work and nursing degrees for
managers and administrators in their
respective departments, Memorial Hermann
requires a bachelor’s degree in nursing to
operate in this capacity.
Another notable difference between these
models of case management has to do with the
implementation of the social work role within
the hospital system. Within Memorial
Hermann and Cleveland Clinic, the social
worker role is designed with the intention of
facilitating the discharge process by
addressing psychosocial barriers to discharge.
As such, their model follows a crisis intervention
model designed around short interventions
that are intended to identify and address
barriers to discharge.
Within these two organizations, social work
has been brought under the umbrella of case
management in an effort to increase operational
efficiency in the assignment of roles and
responsibilities between social work and case
management. MD Anderson, on the other
hand, maintains an independent social work
department that operates on a psychosocial
counseling and intervention model. Within
this model, social workers follow patients in
both the inpatient and outpatient settings, still
assisting in complex discharge planning but
with a larger focus on psychosocial counseling
in a short-term, solution-focused format.
Another useful comparison to be made
between these models relates to how
professionals are assigned to patients within
the hospital system. With some exceptions,
Memorial Hermann, Cleveland Clinic and MD
Anderson all have a unit-based or geographybased case management model, implemented
in an effort to increase operational efficiency.
However, due to the complexity and acuity as
well as the large outpatient focus of MD
Anderson’s patient population, their social
work program has been designed with a service
line approach to facilitate continuity of care.
In certain patient populations (such as
pediatrics), social workers will actually
follow patients in both the inpatient and
outpatient settings.
LESSONS LEARNED AND
RECOMMENDATIONS
This fellowship has been a rewarding
opportunity for me to acclimatize myself to
medical social work as a profession. When I
applied for this fellowship, I did so in the hopes
of becoming better prepared for the hospital
environment. Following these experiences, I
have a better understanding about what this
work entails and how I can continue to grow
as I begin to specialize in my practice.
With the fellowship experience, I was exposed
to a myriad of situations, both good and bad.
While the pace of the fellowship was hectic at
times, this allowed me more opportunities to
learn about the theory and implementation
of case management without the pressure
of also attempting to carry a full caseload
from the start.
Overall, I would highly recommend this
fellowship to new social workers in the field.
As a new social worker “fresh out of school,”
acclimating to social work in the hospital
setting can be difficult, even with internship
experience. The ACMA Social Work Case
Management Fellowship Program provides a
significant educational opportunity for social
workers in this field.
ABOUT THE AUTHOR
Allen Gibson, LMSW, is currently a social
worker at Memorial Hermann Northwest
Hospital, and the 2013 ACMA Social Work
Case Management Fellow. He completed his
Fellowship at Memorial Hermann Health
System. He earned a bachelor’s degree in
psychology and his master’s degree in social
work from North Carolina State University.
Prior to the Fellowship, Mr. Gibson served as
a social work case manager at WakeMed Health
& Hospitals and a respite counselor for NC
START Central Respite (Easter Seals UCP) in
North Carolina.
9
S:7”
ZYVOX® linezolid injection, tablets and for oral suspension
Brief summary of prescribing information.
INDICATIONS AND USAGE ZYVOX is indicated for the treatment of infections caused by
susceptible strains of the designated microorganisms in the specific conditions listed
below. ZYVOX is not indicated for the treatment of Gram-negative infections. It is
critical that specific Gram-negative therapy be initiated immediately if a concomitant
Gram-negative pathogen is documented or suspected [see Warnings and Precautions].
Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and
-resistant isolates) or Streptococcus pneumoniae. Community-acquired pneumonia caused
by Streptococcus pneumoniae, including cases with concurrent bacteremia, or Staphylococcus
aureus (methicillin-susceptible isolates only). Complicated skin and skin structure
infections, including diabetic foot infections, without concomitant osteomyelitis, caused
by Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus
pyogenes, or Streptococcus agalactiae. ZYVOX has not been studied in the treatment
of decubitus ulcers. Uncomplicated skin and skin structure infections caused by
Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes.
Vancomycin-resistant Enterococcus faecium infections, including cases with concurrent
bacteremia. To reduce the development of drug-resistant bacteria and maintain the
effectiveness of ZYVOX and other antibacterial drugs, ZYVOX should be used only to treat
or prevent infections that are proven or strongly suspected to be caused by susceptible
bacteria. When culture and susceptibility information are available, they should be
considered in selecting or modifying antibacterial therapy. In the absence of such data,
local epidemiology and susceptibility patterns may contribute to the empiric selection of
therapy. The safety and efficacy of ZYVOX formulations given for longer than 28 days have
not been evaluated in controlled clinical trials.
CONTRAINDICATIONS ZYVOX formulations are contraindicated for use in patients who
have known hypersensitivity to linezolid or any of the other product components.
Linezolid should not be used in patients taking any medicinal product which inhibits
monoamine oxidases A or B (e.g., phenelzine, isocarboxazid) or within two weeks of
taking any such medicinal product.
ZYVX14CDNY3033_2014_7_9.75_BS_r7.indd 1
ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under
widely varying conditions, adverse reaction rates observed in the clinical trials of a drug
cannot be directly compared to rates in the clinical trials of another drug and may not
reflect the rates observed in practice. Adults The safety of ZYVOX formulations was
evaluated in 2046 adult patients enrolled in seven Phase 3 comparator-controlled clinical
trials, who were treated for up to 28 days. Of the patients treated for uncomplicated skin
and skin structure infections (uSSSIs), 25.4% of ZYVOX-treated and 19.6% of comparatortreated patients experienced at least one drug-related adverse event. For all other
indications, 20.4% of ZYVOX-treated and 14.3% of comparator-treated patients experienced
at least one drug-related adverse event. The incidence (%) of treatment-emergent
adverse events occurring in >1% of adult patients in a trial involving the treatment of
uSSSIs comparing ZYVOX 400 mg PO q12h (n=548) to clarithromycin 250 mg PO q12h
(n=537) were headache 8.8 and 8.4; diarrhea 8.2 and 6.1; nausea 5.1 and 4.5; vomiting 2.0
and 1.5; dizziness 2.6 and 3.0; rash 1.1 and 1.1; anemia 0.4 and 0; taste alteration 1.8 and 2.0;
vaginal moniliasis 1.8 and 1.3; oral moniliasis 0.5 and 0; abnormal liver function tests 0.4
and 0.2; fungal infection 1.5 and 0.2; tongue discoloration 1.3 and 0; localized abdominal
pain 1.3 and 0.6; and generalized abdominal pain 0.9 and 0.4, respectively. The incidence
(%) of treatment-emergent adverse events occurring in >1% of adult patients in all other
indications of ZYVOX 600 mg q12h (n=1498) versus all other comparators§ (n=1464) were
headache 5.7 and 4.4; diarrhea 8.3 and 6.4; nausea 6.6 and 4.6; vomiting 4.3 and 2.3;
dizziness 1.8 and 1.5; rash 2.3 and 2.6; anemia 2.1 and 1.4; taste alteration 1.0 and 0.3;
vaginal moniliasis 1.1 and 0.5; oral moniliasis 1.7 and 1.0; abnormal liver function tests 1.6
and 0.8; fungal infection 0.3 and 0.2; tongue discoloration 0.3 and 0; localized abdominal
pain 1.2 and 0.8; and generalized abdominal pain 1.2 and 1.0, respectively. Of the patients
treated for uSSSIs, 3.5% of ZYVOX-treated and 2.4% of comparator-treated patients
discontinued treatment due to drug-related adverse events. For all other indications,
discontinuations due to drug-related adverse events occurred in 2.1% of ZYVOX-treated
and 1.7% of comparator-treated patients. The most common reported drug-related
adverse events leading to discontinuation of treatment were nausea, headache, diarrhea,
and vomiting. Pediatric Patients The safety of ZYVOX formulations was evaluated in 215
pediatric patients ranging in age from birth through 11 years, and in 248 pediatric
patients aged 5 through 17 years (146 of these 248 were age 5 through 11 and 102 were
age 12 to 17). These patients were enrolled in two Phase 3 comparator-controlled clinical
trials and were treated for up to 28 days. In the study of hospitalized pediatric patients
(birth through 11 years) with Gram-positive infections, who were randomized 2 to 1
(linezolid:vancomycin), mortality was 6.0% (13/215) in the linezolid arm and 3.0% (3/101) in
the vancomycin arm. However, given the severe underlying illness in the patient
population, no causality could be established. Of the pediatric patients treated for uSSSIs,
19.2% of ZYVOX-treated and 14.1% of comparator-treated patients experienced at least
one drug-related adverse event. For all other indications, 18.8% of ZYVOX-treated and
34.3% of comparator-treated patients experienced at least one drug-related adverse
event. The incidence (%) of treatment-emergent adverse events occurring in >1% of
pediatric patients treated for uSSSIs|| with either ZYVOX (n=248) or cefadroxil (n=251) were
diarrhea 7.8 and 8.0; vomiting 2.9 and 6.4; headache 6.5 and 4.0; anemia 0 and 0;
thrombocytopenia 0 and 0; nausea 3.7 and 3.2; generalized abdominal pain 2.4 and 2.8;
localized abdominal pain 2.4 and 2.8; loose stools 1.6 and 0.8; eosinophilia 0.4 and 0.8;
pruritus at non-application site 0.8 and 0.4; and vertigo 1.2 and 0.4, respectively. The
incidence (%) of treatment-emergent adverse events occurring in >1% of pediatric
patients treated for all other indications¶ with either ZYVOX (n=215) or vancomycin (n=101)
were diarrhea 10.8 and 12.1; vomiting 9.4 and 9.1; headache 0.9 and 0; anemia 5.6 and 7.1;
thrombocytopenia 4.7 and 2.0; nausea 1.9 and 0; generalized abdominal pain 0.9 and 2.0;
localized abdominal pain 0.5 and 1.0; loose stools 2.3 and 3.0; eosinophilia 1.9 and 1.0;
pruritus at non-application site 1.4 and 2.0; and vertigo 0 and 0, respectively. Of the
pediatric patients treated for uSSSIs, 1.6% of ZYVOX-treated and 2.4% of comparatortreated patients discontinued treatment due to drug-related adverse events. For all
other indications, discontinuations due to drug-related adverse events occurred in 0.9%
of ZYVOX-treated and 6.1% of comparator-treated patients. Laboratory Abnormalities
ZYVOX has been associated with thrombocytopenia when used in doses up to and
including 600 mg every 12 hours for up to 28 days. In Phase 3 comparator-controlled trials,
the percentage of adult patients who developed a substantially low platelet count
(defined as less than 75% of lower limit of normal and/or baseline) was 2.4% (range among
studies: 0.3 to 10.0%) with ZYVOX and 1.5% (range among studies: 0.4 to 7.0%) with a
comparator. In a study of hospitalized pediatric patients ranging in age from birth
through 11 years, the percentage of patients who developed a substantially low platelet
count (defined as less than 75% of lower limit of normal and/or baseline) was 12.9% with
ZYVOX and 13.4% with vancomycin. In an outpatient study of pediatric patients aged from
5 through 17 years, the percentage of patients who developed a substantially low platelet
count was 0% with ZYVOX and 0.4% with cefadroxil. Thrombocytopenia associated with
the use of ZYVOX appears to be dependent on duration of therapy (generally greater than
2 weeks of treatment). The platelet counts for most patients returned to the normal
range/baseline during the follow-up period. No related clinical adverse events were
identified in Phase 3 clinical trials in patients developing thrombocytopenia. Bleeding
events were identified in thrombocytopenic patients in a compassionate use program for
ZYVOX; the role of linezolid in these events cannot be determined [see Warnings and
Precautions]. Changes seen in other laboratory parameters, without regard to drug
relationship, revealed no substantial differences between ZYVOX and the comparators.
These changes were generally not clinically significant, did not lead to discontinuation of
therapy, and were reversible. The percent of adult patients with at least one substantially
abnormal hematologic** value in patients treated with ZYVOX 400 mg q12h or
clarithromycin 250 mg q12h for uncomplicated skin and skin structure infections were as
follows: hemoglobin (g/dL) 0.9 and 0.0; platelet count (x 103/mm3) 0.7 and 0.8; WBC (x 103/
mm3) 0.2 and 0.6; neutrophils (x 103/mm3) 0.0 and 0.2 respectively. The percent of adult
patients with at least one substantially abnormal hematologic** value in patients treated
with ZYVOX 600 mg q12h or a comparator§ were as follows: hemoglobin (g/dL) 7.1 and 6.6;
platelet count (x 103/mm3) 3.0 and 1.8; WBC (x 103/mm3) 2.2 and 1.3 and neutrophils (x 103/
mm3) 1.1 and 1.2 respectively. The percent of adult patients with at least one substantially
abnormal serum chemistry†† value in patients treated with ZYVOX 400 mg q12h or
clarithromycin 250 mg q12h for uncomplicated skin and skin structure infections were as
follows: AST (U/L) 1.7 and 1.3; ALT (U/L) 1.7 and 1.7; LDH (U/L) 0.2 and 0.2; alkaline
phosphatase (U/L) 0.2 and 0.2; lipase (U/L) 2.8 and 2.6; amylase (U/L) 0.2 and 0.2; total
bilirubin (mg/dL) 0.2 and 0.0; BUN (mg/dL) 0.2 and 0.0; and creatinine (mg/dL) 0.2 and 0.0
respectively. The percent of adult patients with at least one substantially abnormal serum
chemistry†† value in patients treated with ZYVOX 600 mg q12h or a comparator§ were as
follows: AST (U/L) 5.0 and 6.8; ALT (U/L) 9.6 and 9.3; LDH (U/L) 1.8 and 1.5; alkaline
phosphatase (U/L) 3.5 and 3.1; lipase (U/L) 4.3 and 4.2; amylase (U/L) 2.4 and 2.0; total
3/17/14 1:38 PM
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WARNINGS AND PRECAUTIONS Myelosuppression (including anemia, leukopenia,
pancytopenia, and thrombocytopenia) has been reported in patients receiving linezolid.
In cases where the outcome is known, when linezolid was discontinued, the affected
hematologic parameters have risen toward pretreatment levels. Complete blood counts
should be monitored weekly in patients who receive linezolid, particularly in those who
receive linezolid for longer than two weeks, those with pre-existing myelosuppression,
those receiving concomitant drugs that produce bone marrow suppression, or those
with a chronic infection who have received previous or concomitant antibiotic therapy.
Discontinuation of therapy with linezolid should be considered in patients who develop
or have worsening myelosuppression. Peripheral and optic neuropathies have been
reported in patients treated with ZYVOX, primarily in those patients treated for longer
than the maximum recommended duration of 28 days. In cases of optic neuropathy that
progressed to loss of vision, patients were treated for extended periods beyond the
maximum recommended duration. Visual blurring has been reported in some patients
treated with ZYVOX for less than 28 days. Peripheral and optic neuropathy has also been
reported in children. If patients experience symptoms of visual impairment, such as
changes in visual acuity, changes in color vision, blurred vision, or visual field defect,
prompt ophthalmic evaluation is recommended. Visual function should be monitored in
all patients taking ZYVOX for extended periods (≥ 3 months) and in all patients reporting
new visual symptoms regardless of length of therapy with ZYVOX. If peripheral or optic
neuropathy occurs, the continued use of ZYVOX in these patients should be weighed
against the potential risks. Spontaneous reports of serotonin syndrome including fatal
cases associated with the co-administration of ZYVOX and serotonergic agents, including
antidepressants such as selective serotonin reuptake inhibitors (SSRIs), have been
reported. Unless clinically appropriate and patients are carefully observed for signs and/
or symptoms of serotonin syndrome or neuroleptic malignant syndrome-like (NMS-like)
reactions, linezolid should not be administered to patients with carcinoid syndrome
and/or patients taking any of the following medications: serotonin re-uptake inhibitors,
tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptans), meperidine,
bupropion, or buspirone. In some cases, a patient already receiving a serotonergic
antidepressant or buspirone may require urgent treatment with linezolid. If alternatives
to linezolid are not available and the potential benefits of linezolid outweigh the risks
of serotonin syndrome or NMS-like reactions, the serotonergic antidepressant should
be stopped promptly and linezolid administered. The patient should be monitored for
two weeks (five weeks if fluoxetine was taken) or until 24 hours after the last dose of
linezolid, whichever comes first. Symptoms of serotonin syndrome or NMS-like reactions
include hyperthermia, rigidity, myoclonus, autonomic instability, and mental status
changes that include extreme agitation progressing to delirium and coma. The patient
should also be monitored for discontinuation symptoms of the antidepressant. Mortality
Imbalance in an Investigational Study in Patients with Catheter-Related Bloodstream
Infections, including those with catheter-site infections. While causality has not been
established, this observed imbalance occurred primarily in linezolid-treated patients
in whom either Gram-negative pathogens, mixed Gram-negative and Gram-positive
pathogens, or no pathogen were identified at baseline, but was not seen in patients
with Gram-positive infections only. Linezolid is not approved and should not be used for
the treatment of patients with catheter-related bloodstream infections or catheter-site
infections. Linezolid has no clinical activity against Gram-negative pathogens and is not
indicated for the treatment of Gram-negative infections. It is critical that specific Gramnegative therapy be initiated immediately if a concomitant Gram-negative pathogen
is documented or suspected. Clostridium difficile associated diarrhea (CDAD) has been
reported with use of nearly all antibacterial agents, including ZYVOX, and may range in
severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the
normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins
A and B which contribute to the development of CDAD. Hypertoxin producing strains of
C. difficile cause increased morbidity and mortality, as these infections can be refractory
to antimicrobial therapy and may require colectomy. CDAD must be considered in all
patients who present with diarrhea following antibiotic use. Careful medical history
is necessary since CDAD has been reported to occur over two months after the
administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing
antibiotic use not directed against C. difficile may need to be discontinued. Appropriate
fluid and electrolyte management, protein supplementation, antibiotic treatment of
C. difficile, and surgical evaluation should be instituted as clinically indicated. Unless
patients are monitored for potential increases in blood pressure, linezolid should not
be administered to patients with uncontrolled hypertension, pheochromocytoma,
thyrotoxicosis and/or patients taking any of the following types of medications: directly
and indirectly acting sympathomimetic agents (e.g., pseudoephedrine), vasopressive
agents (e.g., epinephrine, norepinephrine), dopaminergic agents (e.g., dopamine,
dobutamine). Lactic acidosis has been reported with the use of ZYVOX. In reported cases,
patients experienced repeated episodes of nausea and vomiting. Patients who develop
recurrent nausea or vomiting, unexplained acidosis, or a low bicarbonate level while
receiving ZYVOX should receive immediate medical evaluation. Convulsions have been
reported in patients when treated with linezolid. In some of these cases, a history of
seizures or risk factors for seizures was reported. Postmarketing cases of symptomatic
hypoglycemia have been reported in patients with diabetes mellitus receiving insulin
or oral hypoglycemic agents when treated with linezolid, a reversible, nonselective
MAO inhibitor. Some MAO inhibitors have been associated with hypoglycemic episodes
in diabetic patients receiving insulin or hypoglycemic agents. While a causal relationship
between linezolid and hypoglycemia has not been established, diabetic patients should
be cautioned of potential hypoglycemic reactions when treated with linezolid. If
hypoglycemia occurs, a decrease in the dose of insulin or oral hypoglycemic agent,
or discontinuation of oral hypoglycemic agent, insulin, or linezolid may be required.
Prescribing ZYVOX in the absence of a proven or strongly suspected bacterial infection
or a prophylactic indication is unlikely to provide benefit to the patient and increases the
risk of the development of drug-resistant bacteria.
S:7”
bilirubin (mg/dL) 0.9 and 1.1; BUN (mg/dL) 2.1 and 1.5; and creatinine (mg/dL) 0.2 and 0.6
respectively. The percent of pediatric patients with at least one substantially abnormal
hematologic‡‡ value in patients treated with ZYVOX or cefadroxil for uncomplicated skin
and skin structure infections|| were as follows: hemoglobin (g/dL) 0.0 and 0.0; platelet
count (x 103/mm3) 0.0 and 0.4; WBC (x 103/mm3) 0.8 and 0.8; neutrophils (x 103/mm3) 1.2
and 0.8 respectively. The percent of pediatric patients with at least one substantially
abnormal hematologic‡‡ value in patients treated with ZYVOX or vancomycin for any other
indication¶ were as follows: hemoglobin (g/dL) 15.7 and 12.4; platelet count (x 103/mm3)
12.9 and 13.4; WBC (x 103/mm3) 12.4 and 10.3 and neutrophils (x 103/mm3) 5.9 and 4.3
respectively. The percent of pediatric patients with at least one substantially abnormal
serum chemistrya value in patients treated with ZYVOX or cefadroxil for uncomplicated
skin and skin structure infections|| were as follows: ALT (U/L) 0.0 and 0.0; lipase (U/L) 0.4 and
1.2; and creatinine (mg/dL) 0.4 and 0.0 respectively. The percent of pediatric patients with
at least one substantially abnormal serum chemistrya value in patients treated with ZYVOX
or vancomycin for any other indication¶ were as follows: ALT (U/L) 10.1 and 12.5; amylase
(U/L) 0.6 and 1.3; total bilirubin (mg/dL) 6.3 and 5.2; and creatinine (mg/dL) 2.4 and 1.0
respectively. Postmarketing Experience The following adverse reactions have been
identified during postapproval use of ZYVOX. Because these reactions are reported
voluntarily from a population of uncertain size, it is not always possible to reliably estimate
their frequency or establish a causal relationship to drug exposure. Myelosuppression
(including anemia, leukopenia, pancytopenia, and thrombocytopenia) has been
reported during postmarketing use of ZYVOX [see Warnings and Precautions]. Peripheral
neuropathy, and optic neuropathy sometimes progressing to loss of vision, have been
reported in patients treated with ZYVOX. Lactic acidosis has been reported with the use
of ZYVOX [see Warnings and Precautions]. Although these reports have primarily been in
patients treated for longer than the maximum recommended duration of 28 days, these
events have also been reported in patients receiving shorter courses of therapy.
Serotonin syndrome has been reported in patients receiving concomitant serotonergic
agents, including antidepressants such as selective serotonin reuptake inhibitors (SSRIs)
and ZYVOX [see Warnings and Precautions]. Convulsions have been reported with the use
of ZYVOX [see Warnings and Precautions]. Anaphylaxis, angioedema, and bullous skin
disorders such as those described as Stevens-Johnson syndrome have been reported.
Superficial tooth discoloration and tongue discoloration have been reported with the use
of linezolid. The tooth discoloration was removable with professional dental cleaning
(manual descaling) in cases with known outcome. Hypoglycemia, including symptomatic
episodes, has been reported [see Warnings and Precautions].
DRUG INTERACTIONS Monoamine Oxidase Inhibitors Linezolid is a reversible, nonselective
inhibitor of monoamine oxidase. Adrenergic and Serotonergic Agents Linezolid has the
potential for interaction with adrenergic and serotonergic agents.
ZYVX14CDNY3033_2014_7_9.75_BS_r7.indd 2
PATIENT COUNSELING INFORMATION Patients should be counseled that antibacterial
drugs including ZYVOX should only be used to treat bacterial infections. They do not
treat viral infections (e.g., the common cold). When ZYVOX is prescribed to treat a
bacterial infection, patients should be told that although it is common to feel better
early in the course of therapy, the medication should be taken exactly as directed.
Skipping doses or not completing the full course of therapy may (1) decrease the
effectiveness of the immediate treatment and (2) increase the likelihood that bacteria
will develop resistance and will not be treatable by ZYVOX or other antibacterial drugs
in the future. Patients should be advised that: ZYVOX may be taken with or without
food. They should inform their physician if they have a history of hypertension. Large
quantities of foods or beverages with high tyramine content should be avoided while
taking ZYVOX. Foods high in tyramine content include those that may have undergone
protein changes by aging, fermentation, pickling, or smoking to improve flavor, such as
aged cheeses, fermented or air-dried meats, sauerkraut, soy sauce, tap beers, and red
wines. The tyramine content of any protein-rich food may be increased if stored for
long periods or improperly refrigerated. They should inform their physician if taking
medications containing pseudoephedrine HCl or phenylpropanolamine HCl, such as cold
remedies and decongestants. They should inform their physician if taking serotonin
re-uptake inhibitors or other antidepressants. Phenylketonurics: Each 5 mL of the
100 mg/5 mL ZYVOX for Oral Suspension contains 20 mg phenylalanine. The other ZYVOX
formulations do not contain phenylalanine. Contact your physician or pharmacist.
They should inform their physician if they experience changes in vision. They should
inform their physician if they have a history of seizures. Diarrhea is a common problem
caused by antibiotics, which usually ends when the antibiotic is discontinued. Sometimes
after starting treatment with antibiotics, patients can develop watery and bloody stools
(with or without stomach cramps and fever) even as late as two or more months after
having taken the last dose of the antibiotic. If this occurs, patients should contact their
physician as soon as possible. Inform patient, particularly those with diabetes mellitus
that hypoglycemic reactions, such as diaphoresis and tremulousness, along with low
blood glucose measurements may occur when treated with linezolid. If such reactions
occur, patients should contact a physician or other health professional for proper
treatment.
§
Comparators included cefpodoxime proxetil 200 mg PO q12h; ceftriaxone 1 g IV q12h;
dicloxacillin 500 mg PO q6h; oxacillin 2 g IV q6h; vancomycin 1 g IV q12h.
||
Patients 5 through 11 years of age received ZYVOX 10 mg/kg PO q12h or cefadroxil
15 mg/kg PO q12h. Patients 12 years or older received ZYVOX 600 mg PO q12h or
cefadroxil 500 mg PO q12h.
¶
Patients from birth through 11 years of age received ZYVOX 10 mg/kg IV/PO q8h or
vancomycin 10 to 15 mg/kg IV q6-24h, depending on age and renal clearance.
**
<75% (<50% for neutrophils) of Lower Limit of Normal (LLN) for values normal at
baseline; <75% (<50% for neutrophils) of LLN and of baseline for values abnormal at
baseline.
††
>2 x Upper Limit of Normal (ULN) for values normal at baseline; >2 x ULN and >2 x
baseline for values abnormal at baseline.
‡‡
<75% (<50% for neutrophils) of Lower Limit of Normal (LLN) for values normal at
baseline; <75% (<50% for neutrophils) of LLN and <75% (<50% for neutrophils, <90% for
hemoglobin if baseline <LLN) of baseline for values abnormal at baseline.
a
>2 x Upper Limit of Normal (ULN) for values normal at baseline; >2 x ULN and >2 (>1.5 for
total bilirubin) x baseline for values abnormal at baseline.
Rx only
Rev. January 2014
3/17/14 1:38 PM
S:9.75”
USE IN SPECIFIC POPULATIONS Pregnancy Teratogenic Effects – Pregnancy Category C
Linezolid was not teratogenic in mice, rats, or rabbits at exposure levels 6.5-fold (in
mice), equivalent to (in rats), or 0.06-fold (in rabbits) the expected human exposure level,
based on AUCs. However, embryo and fetal toxicities were seen (see Non-teratogenic
Effects). There are no adequate and well-controlled studies in pregnant women. ZYVOX
should be used during pregnancy only if the potential benefit justifies the potential risk
to the fetus. Non-teratogenic Effects In mice, embryo and fetal toxicities were seen only
at doses that caused maternal toxicity (clinical signs and reduced body weight gain). A
dose of 450 mg/kg/day (6.5-fold the estimated human exposure level based on AUCs)
correlated with increased postimplantational embryo death, including total litter loss,
decreased fetal body weights, and an increased incidence of costal cartilage fusion. In
rats, mild fetal toxicity was observed at 15 and 50 mg/kg/day (exposure levels 0.22-fold
to approximately equivalent to the estimated human exposure, respectively, based on
AUCs). The effects consisted of decreased fetal body weights and reduced ossification of
sternebrae, a finding often seen in association with decreased fetal body weights. Slight
maternal toxicity, in the form of reduced body weight gain, was seen at 50 mg/kg/day.
In rabbits, reduced fetal body weight occurred only in the presence of maternal toxicity
(clinical signs, reduced body weight gain and food consumption) when administered at
a dose of 15 mg/kg/day (0.06-fold the estimated human exposure based on AUCs). When
female rats were treated with 50 mg/kg/day (approximately equivalent to the estimated
human exposure based on AUCs) of linezolid during pregnancy and lactation, survival
of pups was decreased on postnatal days 1 to 4. Male and female pups permitted to
mature to reproductive age, when mated, showed an increase in preimplantation loss.
Nursing Mothers Linezolid and its metabolites are excreted in the milk of lactating rats.
Concentrations in milk were similar to those in maternal plasma. It is not known whether
linezolid is excreted in human milk. Because many drugs are excreted in human milk,
caution should be exercised when ZYVOX is administered to a nursing woman. Pediatric
Use The safety and effectiveness of ZYVOX for the treatment of pediatric patients with
the following infections are supported by evidence from adequate and well-controlled
studies in adults, pharmacokinetic data in pediatric patients, and additional data from a
comparator-controlled study of Gram-positive infections in pediatric patients ranging
in age from birth through 11 years [see Indications and Usage]: nosocomial pneumonia,
complicated skin and skin structure infections, community-acquired pneumonia (also
supported by evidence from an uncontrolled study in patients ranging in age from
8 months through 12 years), vancomycin-resistant Enterococcus faecium infections.
The safety and effectiveness of ZYVOX for the treatment of pediatric patients with
the following infection have been established in a comparator-controlled study in
pediatric patients ranging in age from 5 through 17 years: uncomplicated skin and
skin structure infections caused by Staphylococcus aureus (methicillin-susceptible strains
only) or Streptococcus pyogenes. Pharmacokinetic information generated in pediatric
patients with ventriculoperitoneal shunts showed variable cerebrospinal fluid (CSF)
linezolid concentrations following single and multiple dosing of linezolid; therapeutic
concentrations were not consistently achieved or maintained in the CSF. Therefore, the
use of linezolid for the empiric treatment of pediatric patients with central nervous
system infections is not recommended. The pharmacokinetics of linezolid have been
evaluated in pediatric patients from birth to 17 years of age. In general, weight-based
clearance of linezolid gradually decreases with increasing age of pediatric patients.
However, in preterm (gestational age < 34 weeks) neonates < 7 days of age, linezolid
clearance is often lower than in full-term neonates < 7 days of age. Consequently,
preterm neonates < 7 days of age may need an alternative linezolid dosing regimen of
10 mg/kg every 12 hours. In limited clinical experience, 5 out of 6 (83%) pediatric patients
with infections due to Gram-positive pathogens with minimum inhibitory concentrations
(MICs) of 4 mcg/mL treated with ZYVOX had clinical cures. However, pediatric patients
exhibit wider variability in linezolid clearance and systemic exposure (AUC) compared
with adults. In pediatric patients with a sub-optimal clinical response, particularly those
with pathogens with MIC of 4 mcg/mL, lower systemic exposure, site and severity of
infection, and the underlying medical condition should be considered when assessing
clinical response. Geriatric Use Of the 2046 patients treated with ZYVOX in Phase 3
comparator-controlled clinical trials, 589 (29%) were 65 years or older and 253 (12%)
were 75 years or older. No overall differences in safety or effectiveness were observed
between these patients and younger patients, and other reported clinical experience has
not identified differences in responses between the elderly and younger patients, but
greater sensitivity of some older individuals cannot be ruled out.
OVERDOSAGE In the event of overdosage, supportive care is advised, with maintenance
of glomerular filtration. Hemodialysis may facilitate more rapid elimination of linezolid.
In a Phase 1 clinical trial, approximately 30% of a dose of linezolid was removed during
a 3-hour hemodialysis session beginning 3 hours after the dose of linezolid was
administered. Data are not available for removal of linezolid with peritoneal dialysis
or hemoperfusion. Clinical signs of acute toxicity in animals were decreased activity
and ataxia in rats and vomiting and tremors in dogs treated with 3000 mg/kg/day and
2000 mg/kg/day, respectively.
FALL EDITION 2014
Form Over Substance: CMS Reconsiders
Certification Requirement for All Inpatient
Hospital Admissions
Jessica L. Gustafson, Esq.; Abby Pendleton, Esq.
THESE AUTHORS HAVE NO FINANCIAL RELATIONSHIPS WITH COMMERCIAL INTERESTS TO DISCLOSE.
Beginning with inpatient hospital
admissions on October 1, 2013, the
Centers for Medicare & Medicaid Services
(“CMS”) significantly altered its Medicare
Part A inpatient hospital admission
criteria and documentation requirements.
In particular, in its 2014 Inpatient
Prospective Payment System (“IPPS”)
Final Rule, CMS instituted new guidelines
to establish the medical necessity of
inpatient hospital admissions (i.e.,
creating the “2-midnight rule”) and
created conditions of Medicare Part A
payment related to physician inpatient
admission orders and certifications.1 In
the last issue of Collaborative Case
Management, we reported that,
“Hospitals
Must
Continue
Implementation of Controversial
2-Midnight Rule.” However, changes
may be soon coming with respect to CMS’
requirement for physician certifications
of the medical necessity of all inpatient
hospital admissions as a condition of
Part A payment.
LEARNING OBJECTIVES
1. Discuss the current status of the
2-midnight rule
2. Discuss the current status of the
certification requirement for all inpatient
hospital admissions
3. Gain a better understanding of the
requirement and its implications
for hospitals
INPATIENT HOSPITAL CERTIFICATION
REQUIREMENT – BACKGROUND
Pursuant to Section 1814 (a) (3) of the Social
Security Act (42 U.S.C. § 1395f (a) (3)), as a
condition of Medicare Part A payment for
inpatient hospital services (other than inpatient
psychiatric hospital services), which are
furnished “over a period of time,” a physician
must certify (and recertify) that such services
are required to be given on an inpatient basis.
The statute limits the certification requirement
to “such cases, with such frequency, and
accompanied by such supporting material,
appropriate to the cases involved, as may be
provided by regulations…” The statute requires
that the first certification be completed no later
than the twentieth day following an inpatient
hospital admission. Implementing regulations
are codified at 42 C.F.R. § 424.13.
Prior to publication of the 2014 IPPS Final
Rule, the certification requirement was
enforced only with respect to long-term hospital
stays and outlier cases. In its 2014 IPPS
Proposed Rule, CMS first formally articulated
its position that certifications of medical
necessity were required as a condition of
payment for all inpatient hospital admissions.2
However, of note, prior to the publication of
the 2014 IPPS Proposed Rule, certain CMS
contractors unsuccessfully had argued to the
Medicare Appeals Council (the “Council”) that
certifications were required for all inpatient
hospital admissions, including short stays.3
In the 2014 IPPS Proposed Rule, CMS classified
its new position as a “clarification.”4 However,
as a practical matter, prior to the effective date
of the 2014 IPPS Final Rule, physicians did not
necessarily complete certification statements
for all inpatient hospital admissions, other than
long-term hospital stays and outlier cases.
13
COLLABORATIVE CASE MANAGEMENT | ACMAWEB.ORG
Commenters to the 2014 IPPS Proposed Rule
argued that CMS’ stated intent to require
certifications for all inpatient hospital
admissions (and not just for extended hospital
stays and outlier cases) was not supported by
the language or the legislative history of Section
1814 (a) (3) of the Social Security Act:
[I]n the Social Security Amendments of
1967, Congress amended the statutory
language from requiring physician
certification of hospital inpatient services
to requiring a physician certification only
for “inpatient hospital services…
which are furnished over a period
of time.” Moreover, the commenters
cited congressional reports [i.e., S. Rep.
No. 90-744, at 239 (1967), H.R. Rep. No.
90-544 at 149 (1967)] explaining this
statutory change by stating that it
“elimitate[d] the requirement for hospital
insurance payments that there be a
physician’s certification of medical
necessity with respect to admission to
hospitals which are neither psychiatric
nor tuberculosis institutions” and that
such a certification is required “only
in cases of hospital stays of extended
duration.” The commenters suggested
that the House report also explains the reason
for the change, stating that “admissions to
general hospitals are almost always medically
necessary and the requirement for a
physician’s certification of this fact results in
largely unnecessary paperwork” (H.R. Rep.
No. 90-544, at 38 (1967)… 5
Ultimately, CMS found the commenters’
arguments unpersuasive. Effective October 1,
2014, as a condition of Medicare Part A
payment, hospitals are obligated to obtain
physician6 certification statements for all
inpatient hospital admissions prior to every
hospital inpatient’s discharge that documented
the following elements: (1) that the services
were provided in accordance with 42 C.F.R. §
412.3; (2) the reasons for the patient’s inpatient
hospital admission (or special or unusual
circumstances in cost outlier cases; (3) the
estimated time the patient will require hospital
care; and (4) the plans for post-hospital care.7
In its 2014 IPPS Final Rule, CMS stated that
it was “not finalizing new documentation
requirements”8 with respect to certification
statements. Although certification statements
must be documented via a separate signed
statement within the medical record, a specific
14
form is not required.9 Certification statements
may be present on any documentation within
the patient file as long as the method chosen
permits verification.10
On September 5, 2013, CMS issued its first
round of sub-regulatory guidance on the topic
of Hospital Inpatient Admission Order and
Certification. In this document, CMS instructed
medical reviewers regarding the “default
methodology” for identifying compliance with
the certification regulations. In particular, CMS
instructed that in the absence of a specific
certification form, reviewers should look within
the record for the requisite elements (e.g.,
physician orders, diagnosis and plan, physician
notes, discharge planning instructions).11
Thereafter, on January 30, 2014, CMS issued
a second document entitled Hospital Admission
Order and Certification, which removed the
specific “default methodology” language;
however, the substance of the “default
methodology” remained part of the guidance.12
Following the effective date of the 2014 IPPS
Final Rule, some hospitals adopted certification
forms to meet the requirements of 42 C.F.R.
§ 424.13; others updated their electronic health
record; still others counted on the physician
documentation within the record to fulfill
the certification requirements. Many
hospitals reported difficulty complying with
the new requirements.
During the “probe and educate” medical review
process, many hospitals experienced claim
denials based on allegations of non-compliance
with the certification requirements, despite the
fact that each certification element was
documented by a signed statement within the
medical record prior to discharge. In addition,
many hospitals experienced claim denials for
the simple reason that hospitals were unable
to obtain signed statements within the medical
record prior to each patient’s discharge.
INPATIENT HOSPITAL
CERTIFICATION REQUIREMENT –
WHAT DOES THE FUTURE HOLD?
In a change of course, in its 2015 Outpatient
Prospective Payment System (“OPPS”)
Proposed Rule, CMS proposed the following:
“[A]fter consideration of public feedback, our
experience under the existing regulations, and
our policy goals, we are proposing to change
our interpretation of section 1814 (a) (3) of the
Act to require a physician certification only for
long-stay cases and outlier cases.13”
Additional requirements of the 2014 IPPS
Final Rule (related to physician orders and
the 2-midnight rule), would remain in place
unchanged under the 2015 OPPS
Proposed Rule.
In proposing to abandon its requirement for
physician certifications of the medical necessity
for inpatient hospital admissions for all
admissions, CMS noted that, “In our current
regulations, we have interpreted the statute’s
requirement of a physician certification for
inpatient hospital services furnished “over a
period of time” to apply to all inpatient
admissions. While this is not the only possible
interpretation of the statute, we believe that it
is a permissible interpretation.”14 CMS
proposes to maintain the condition of payment
related to inpatient hospital admission orders
based on its general authority to create
regulations necessary to carry out the Medicare
program authorized by Section 1871 of the
Social Security Act (42 U.S.C. § 1395hh), rather
than as an element of certification under
Section 1814 (a) (3).15
If the 2015 OPPS Proposed Rule is
implemented as proposed, hospitals are not
off the hook with respect to physician
documentation. Under the 2015 OPPS
Proposed Rule, CMS stated its belief that “the
admission order, medical record, and progress
notes will contain sufficient information to
support the medical necessity of an inpatient
admission,” but alleviated hospitals of the
burden to obtain signed statements prior to
each hospital inpatient’s discharge.16
In summary, in its 2015 OPPS Proposed Rule,
CMS proposed to eliminate the current
requirement for physician certification of the
medical necessity of all inpatient hospital
admissions. Rather, the certification
requirements codified at 42 C.F.R. § 424.13
would be limited to admissions of 20 or more
inpatient days or outlier cases as defined by
42 C.F.R. Part 412 Subpart F. Significantly,
the 2015 OPPS Proposed Rule has not
been finalized. Currently, hospitals
must continue to abide by the
certification requirements for all
inpatient hospital admissions. “Probe
and educate” medical reviews continue,
and medical review contractors are
assessing hospitals for compliance with the
2014 IPPS Final Rule (including the
certification regulations).
FALL EDITION 2014
ABOUT THE AUTHORS
Jessica L. Gustafson, Esq. and Abby
Pendleton, Esq. are founding shareholders
with the health care law firm, The Health Law
Partners, P.C. The firm represents hospitals,
physicians, and other healthcare providers and
suppliers with respect to their healthcare legal
needs. Ms. Gustafson and Ms. Pendleton colead the firm’s Recovery Audit and Medicare
appeals practice group, and specialize in a
number of areas, including Medicare, Medicaid
and other payor audit defense and appeals;
healthcare regulatory matters; compliance;
HIPAA privacy and security compliance
matters; overpayment refunds; reimbursement
and contracting matters; and payor departicipation matters.
REFERENCES
1
78 Fed. Reg. 50496 et seq. (August 19, 2013).
See also 42 C.F.R. § 412.3 and 42 C.F.R. § 424.13.
78 Fed. Reg. 27486 at 27645 (May 10, 2013):
“During Medicare contractor review of an
inpatient admission, documentation in the
medical record is evaluated in conjunction
with the physician order and the physician
certification that is also required for payment
of hospital inpatient services under section
1814(a) of the Act and 42 CFR 424.13”
(emphasis added).
2
See e.g., In the case of King’s Daughters
Medical Center, M-12-1231 (DAB June 26,
3
2012), in which the Medicare Appeals Council
(the “Council”) found (in response to such
argument), “The physician in this case could
not provide ‘reasons for continued
hospitalization’ because the beneficiary had
just been admitted. Nor could the physician
provide ‘reasons for special or unusual services
for cost outlier cases.’ There is nothing in the
record to indicate this was identified as a cost
outlier case. Therefore section 424.13 of the
regulations does not apply here.”
78 Fed. Reg. at 50938.
4
78 Fed. Reg.
(emphasis added).
5
at
50938-50939
6
Authority to sign the certification statements
is limited to the physician (i.e., MD, DO, DDS
in certain circumstances, and podiatrists in
certain circumstances) responsible for the case
or another physician who has knowledge of
the case and who is authorized to do so by the
responsible physician or by the hospital’s
medical staff. A member of the hospital’s
utilization review committee would satisfy this
requirement. In addition, in contrast to the
admitting practitioner, the certifying physician
need not have admission privileges at the
hospital. See “Hospital Inpatient Admission
Order and Certification,” January 30, 2014,
available at http://cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
AcuteInpatientPPS/Downloads/IPCertification-and-Order-01-30-14.pdf.
7
42 C.F.R. §412.13 (a).
See also See “Hospital Inpatient Admission
Order and Certification,” September 5, 2013,
available at http://cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
AcuteInpatientPPS/Downloads/IPCertification-and-Order-09-05-13.pdf and
“Hospital Inpatient Admission Order and
Certification,” January 30, 2014, available at
http://cms.gov/Medicare/Medicare-Fee-forService-Payment/AcuteInpatientPPS/
Downloads/IP-Certification-andOrder-01-30-14.pdf.
78 Fed. Reg. at 50940.
Id.
10
Id.
8
9
11
See “Hospital Inpatient Admission Order
and Certification,” September 5, 2013, available
at http://cms.gov/Medicare/Medicare-Feefor-Service-Payment/AcuteInpatientPPS/
Downloads/IP-Certification-andOrder-09-05-13.pdf.
See “Hospital Inpatient Admission Order
and Certification,” January 30, 2014, available
at http://cms.gov/Medicare/Medicare-Feefor-Service-Payment/AcuteInpatientPPS/
Downloads/IP-Certification-andOrder-01-30-14.pdf.
12
79 Fed. Reg. 40916 at 41057 (July 14, 2014)
(emphasis added).
13
14
15
79 Fed. Reg. at 41057.
Id.
16
Id.
15
COLLABORATIVE CASE MANAGEMENT | ACMAWEB.ORG
Building the Foundation to Reduce Readmissions
for Heart Failure
Gail Serralta, RN, BSN, CCM, CMAC; Michelle Hendricks, RN, BSN
THESE AUTHORS HAVE NO FINANCIAL RELATIONSHIPS WITH COMMERCIAL INTERESTS TO DISCLOSE.
The Centers for Medicare and Medicaid
Services’ (CMS) readmission reduction
initiative has sparked a nationwide push
to develop and implement processes to
prevent or at least reduce unplanned
readmissions to the acute care setting. Like
many other medical centers nationwide,
Methodist Dallas Medical Center
recognized opportunities to reduce the
readmission rate for its heart failure
patient population.
LEARNING OBJECTIVES
1.Discuss a readmissions reduction
initiative for the heart failure
patient population
2.Explain the main elements – both
inpatient and post-discharge – of
MDMC’s heart failure readmissions
reduction initiative
ABOUT METHODIST DALLAS
MEDICAL CENTER
Methodist Dallas Medical Center (MDMC)
has served North Texas since 1927. It is a Level
II Trauma Center with medical education and
16
residency programs and transplant programs
for adult liver, kidney and pancreas transplants.
It is also the main teaching and referral center
for Methodist Health System. MDMC is a 558bed facility, and its medical staff includes more
than 250 physicians with expertise in more
than 60 medical specialties.
BACKGROUND
From 2010 to 2012, the 30-day readmission
rate at MDMC had been climbing (see Figure
A). The CMS Readmission Reduction report
also confirmed that this was an opportunity
for improvement for MDMC (see Figure B.)
FALL EDITION 2014
Figure A
on improving transitions of care.
Based on the team’s findings, it developed and
initiated a program with a focus on increasing
patient self-care management abilities. While
the patient was in the hospital, the CBCM would
provide self-management and disease process
education and training to the patient and their
caregivers. This would be followed by telephonic
follow-up after discharge to provide support
and encouragement as new skills and knowledge
were applied.
CMS Readmission Reduction Report:
July 2008-June 2011
Figure B
MDMCNational
Crude Rate
28.4%
24.6%
Risk Standardized
Readmission Rate
27.3%
25.3%
In Fiscal Year 2013, MDMC had 503 inpatient
admissions with a primary ICD-9 diagnosis of
Heart Failure (HF). For the organization’s HF
patients, the average patient age is 66.2 with
a payer mix shown in Figure C. Almost all of
MDMC’s HF patients are managed by its
hospitalist group with only 15 patients, or
2.98%, managed by a specialist. Roughly half
of MDMC’s hospitalists’ patients are seen by
its teaching service.
Figure C
Payer Type
Admissions
Percent
Medicare
23145.92%
Managed Medicare
123
24.45%
Self Pay
56
11.13%
Managed Medicaid
51
10.14%
Private
377.36%
Medicaid
50.99%
At MDMC, the HF Readmission Reduction
Program was led by the director of care
management and a community based case
manager (CBCM). The journey began with
completing an extensive analysis of the
organization’s HF patient population, with a
focus on patients with one or more 30-day
readmission. The team also performed
an extensive review of the literature to
determine best practice guidelines for HF
patients, and recommendations related to
decreasing readmissions.
MDMC modeled its program development
on existing readmission reduction programs,
including the Better Outcomes for Older Adults
through Safe Transitions (BOOST) program,
Reengineered Hospital Discharge (Project
RED), State Action on Avoidable
Rehospitalizations (STAAR), and Dr. Eric
Coleman’s Care Transitions Program. For HF,
disease self-care management plays a key role
in keeping patients well and out of the
hospital.1,2,3 Patients with HF must have both
the knowledge and ability to take their
medications, eat a low sodium diet, be
physically active, and identify and respond to
changes in signs and symptoms of their
disease.1,2,3 The American Heart Association
(AHA) and the Heart Failure Society of America
(HFSA) both recommend not only educating
patients about their disease, but also teaching
them skills to apply the knowledge.1,2,3 Routine
screening for barriers to self-care and
appropriate referrals to post-acute services
promote self-care. The guidelines and
recommendations from AHA and HFSA fit
well with the increased case management/
coaching recommended by programs focused
MDMC utilizes the Plan-Do-Study-Act cycle
to review quality improvement programs. As
the team continuously reviewed program data,
they were surprised to find several opportunities
to strengthen the hospital’s patient care
processes in order to have the patient achieve
successful self-management of their disease
process. The team also needed to build a
stronger foundation during the patient stay,
from admission to discharge. At that point it
was determined that if any meaningful impact
was to occur on reducing readmission rates
for this patient population, the focus had to be
on the acute care processes first. The program
shifted focus from transitions of care to the
application of best practice guidelines for a
hospitalized patient, 1 and a Heart Failure
Clinical Pathway and Heart Failure Order Set
were developed. Patient self-management
education and training would still occur while
the patient was in the hospital, but the team
also worked to support adherence to the HF
clinical pathway and order set.
METHOD
Like many hospitals, when MDMC leadership
first decided to create a program to address
30-day readmissions, they began by
establishing a committee. The Readmission
Reduction Steering Committee was created to
look at all readmissions, with HF readmissions
to be the first diagnosis on focus. Hospital
administration provided the strong support
needed to gain multidisciplinary engagement
across departments. Throughout the life of the
program and as focuses shifted, committee
membership changed, but initial committee
members included the organization’s
cardiology physician champion, a hospitalist,
nurse managers from the telemetry floors,
nursing leadership, pharmacy leadership, the
outpatient teaching clinic administrator, the
Community CBCM, a registered dietitian, and
a cardiac rehab specialist There were also ad
17
COLLABORATIVE CASE MANAGEMENT | ACMAWEB.ORG
hoc members from the organization’s
accountable care organization (ACO), the
informatics department, palliative care, quality,
and the department of education (DOE). The
committee was chaired by the director of care
management who, with the CBCM, reported
bi-monthly to the executive steering committee.
The Executive Steering Committee meeting
was attended by the cardiology physician
champion, chief quality/medical informatics
officer, director of clinical outcomes, VP of
finance, VP of operations, and VP of nursing.
The steering committee met on a monthly
basis, initially to discuss and direct program
development and later to review outcomes and
opportunities for program improvement. The
CBCM would run monthly readmissions data
and present progress on program development
and implementation. The executive committee
provided guidance and support needed to
resolve barriers to implementation of the
recommendations from the steering committee.
From the analysis of HF patients and the
review of literature, the team at MDMC created
an outline of what an optimal case managementdriven HF readmission reduction program
would look like. Then they met with frontline
staff and physicians to discuss current
practices. They also received input from
hospital leadership regarding how best to align
the program with the hospital’s mission and
goals. Taking the parts of their ideal program
that fit well with the hospital’s goals and had
the greatest potential for significant impact,
the team then created an initial outline of a
multi-phase program.
The identified purpose of the program was to
establish a community care approach to
managing the HF patient population at MDMC.
The three goals of the program were to 1)
reduce the 30-day readmission rate, 2) reduce
the average LOS, and 3) improve HCAPS scores
for selected domains.
PROGRAM SUMMARY
WHILE INPATIENT:
1.CBCM review case due to referral or
case finding.
2.Focus on population with diagnosis of HF
3.Use high risk screening tool to identify
patient that will have greatest benefit.
4.If patient admitted to program, CBCM
will implement and coordinate multidisciplinary team approach. i.e. Nutrition
18
Consult, Pharmacy Consult, Nursing,
Social Work and any other discipline
deemed necessary for comprehensive
management of individual patient.
5.Coordinate and monitor the team
approach to educating the patient /
caregiver about the patient’s disease and
their medications throughout the stay.
6.Arrange all post discharge aftercare with
patients and families. Ensure
appointments are made prior to discharge
and, if patient agrees to participate in the
Walgreens program, ensure all new
prescriptions are filled and delivered to
the patient room prior to discharge.
7.Provide ‘Transition of Care’ packet and
ensure teaching with patient and caregiver
complete and thorough regarding
discharge plan.
8.Provide a scale to patients who do not
have one.
POST DISCHARGE:
9.Follow up telephonically post discharge
with patient/ caregiver within 48-72 post
discharge and as frequently as necessary
depending on patient need.
10. Communicate and collaborate with post
acute service providers until patient
discharged from CBCM program.
(‘Discharged’ patients will still be
monitored for future readmissions)
11. Average length of time active in program
anticipated to be 30-90 days.
12. Track, trend and report statistical
information related to the
program interventions.
The committee spent several months
discussing the details of how each part of the
program was to be implemented. It was finally
decided that the most important element was
for the CBCM to start seeing patients and the
other various parts of the program would be
implemented in phases.
The organization’s CBCM began seeing
patients on January 28, 2013. The CBCM
continuously gathered outcomes data and
brought it to the monthly readmission reduction
steering committee meeting. Three months
into the program, the data suggested that there
were several opportunities to strengthen patient
care processes on both the nursing and
physician side. There were three main areas of
opportunity the steering committee identified.1)
Knowledge of bedside staff, 2) Standardization
of treatment, 3) Patient education.
HOSPITAL STAFF EDUCATION
A subcommittee was established, which included
nurse managers and staff from the telemetry
floors, the DOE, and the CBCM. The goals of the
subcommittee were to identify specific gaps in
the knowledge and skillsets of bedside staff,
develop and implement training tools to address
those gaps, and evaluate the effectiveness of the
training. Bedside staff included patient care
technicians (PCT) and nurses.
PCTs were provided education and training on
the consistent collection, accurate measurement
and documentation of patient intake and output
of fluids along with daily morning standing
weights. Treatment decisions were being made
based on the assessment findings and
documentation results therefore it was vital that
processes were consistent across all units and
all shifts. In-services were conducted on the
unit then competency check-offs and ongoing
monitoring ensured application of the training.
The CBCM did regular chart audits to review
the accuracy of the documentation of I&Os
and daily weights.
Nursing received in-depth education on the
care and management of the HF patient in an
acute care setting. This included the importance
of strict I&Os, patient education, and accurate
cardiovascular assessments. Bedside nurses
from the primary heart failure unit, who were
highly engaged in the initiative, were asked to
complete online CEU training courses and
become heart failure subject matter experts
(SME) for the facility. The SMEs were then
able to be a resource of information for the rest
of the unit staff and other units in the hospital.
The SMEs also developed poster education
boards for both nurses and for patient families
that were posted on the unit.
The CBCM also created binders with up-todate patient care standards and
recommendations from the American Heart
Association (AHA) and the American College
of Cardiology (ACC) that were placed on the
telemetry units. The CBCM attended staff
meetings and shift changes to discuss the HF
program and answer questions – this included
attending shift change on the weekend and at
night shift, to ensure that everyone was
included in the discussion.
Initially, the challenges faced with hospital
staff education were identifying what the
FALL EDITION 2014
educational gaps were, who was going to
provide the education, and how the
effectiveness of the education provided would
be evaluated. Once the education began,
challenges included initial buy-in from staff,
the ongoing monitoring of staff compliance,
and training new staff.
STANDARDIZATION OF TREATMENT
Standardization of patient care between
physicians and residents was another
opportunity identified. Review of patient charts
showed significant variation in practice
patterns among practitioners. Corporate
leadership at Methodist Health System, a fourhospital system which includes MDMC, set a
goal to standardize the care of the HF patient
across the system by creating a HF clinical
pathway and admission order set. The
cardiology physician champion, hospitalist
representative, and CBCM reviewed current
best practice guidelines from the AHA and
ACC to develop the pathway and order set.
Both were then reviewed by bedside nursing,
pharmacy, cardiology and the hospitalists at
MDMC. The draft pathway and order set were
then shared with other cardiologists across the
Methodist system to allow opportunity for input
and to increase buy-in among the cardiologists.
Education was provided to the hospitalists
and residents regarding the availability of the
new heart failure order sets. The order sets,
clinical pathways and patient teaching booklet
were bundled in a blue folder and placed in
the ED dictation room for the admitting
physician to use. These documents were also
on the telemetry floors, where most of the heart
failure patients were admitted. Nursing and
unit secretaries monitored the admitting
diagnoses as the patients came to the floor. If
the diagnosis was indicated to be heart failure,
the unit staff would contact the physician to
inquire if they would like to implement the
new heart failure order set. Sometimes the
answer was “yes” and sometimes it was “no”
but the question was always asked. If the
patient was actively being treated for HF
exacerbation, a HF Clinical Pathway was to be
placed in the chart, even if the admitting
diagnosis was not HF.
The HF Readmission Reduction program as
a whole was initially met with skepticism from
the physicians and residents. Their doubt
stemmed from the potential for success of the
program and a pervasive feeling that
readmissions were unavoidable for this patient
population. This belief led to passive resistance
to the use of the HF Admission Order Set and
adherence to the clinical pathway.
The CBCM provided multiple in-services with
the hospitalist group and residents to review
best practice guidelines and statistical
information on MDMC patient data. Data
included anticipated length of stay based on
severity of illness compared with actual length
of stay, readmission rates related to course of
treatment, and mortality data. Treatment goals
that were seen as the biggest opportunity for
improvement were stabilizing patients on their
home dose of diuretic for 24 hours before
discharge, diuresing patients to their “dry
weight,” and appropriate discharge disposition.
The health system as a whole made the
conscious decision to potentially add one day
to the length of stay to ensure that the patient
was being discharged on the appropriate
medications to prevent readmission.
In order for the physicians to evaluate their
treatment, they needed accurate I&Os, weights
and cardiovascular assessments. This further
supported the need for hospital staff education.
Education was provided to hospitalists and
residents regarding discharge disposition
criteria for HF patients. Representatives from
area post- acute providers presented at the
monthly physician meetings to ensure they
were aware of options available for patients.
Physicians were also encouraged to address
discharge planning earlier in the stay so that
there would not be a delay in discharge for
patients who met the criteria for post-acute
services. Physicians were also encouraged to
discuss treatment options with the advanced
stage HF patients. There are three facilities in
Dallas that provide LVAD and heart transplant
as treatment options, but MDMC does not.
Several patients, who readmitted repeatedly,
were identified as appropriate for referral to
one of those programs, but for multiple
reasons, a referral had not been made. There
were other patients with advanced HF who
did not qualify for a LVAD or transplant, and
physicians were encouraged to discuss the
option of palliative care with the patient.
To address concerns that following the clinical
pathway might increase LOS, a physician-led
daily huddle to discuss patient progression
and barriers to discharge was piloted on the
unit where most of the heart failure patients
were admitted. The hospital’s physician advisor
facilitated the Monday-Friday meeting. The
meeting was attended by the CBCM, unit
manager or charge nurse, case manager and
social worker for the unit. The physicians would
come and discuss the treatment plan and
discharge plan for any patient with a LOS ≥3.
During this huddle there was discussion regarding
heart failure care, patient needs post-discharge,
transition to oral medications for 24 hours prior
to discharge, and the possible benefits to the
patient of home health care evaluation.
Push-back from physicians is an ongoing
challenge. Although physicians are reminded
of best practice guidelines throughout the
patient’s stay, they may choose not to use the
HF order set or adhere to the clinical pathway.
The CBCM and bedside staff can have educated
conversations with the physician about the
plan of care, but final decisions about treatment
plans are made by the physician. The key in
achieving buy-in is evidence that indicates a
significant impact on improved patient
outcomes to result in changing their practice
patterns. Like other groups, MDMC’s
hospitalists believe that their patient population
is terminally unique, sicker and more
complicated than patients at other facilities.
Presenting data from other facilities was not
significant to them. Presenting the physicians
with outcomes data from statistical analysis
of MDMC’s own patient population was the
key in gaining support from the physicians.
PATIENT EDUCATION NEEDS
HF is a chronic disease that has to be managed
by the patient to prevent exacerbation and the
need for hospital admission. Many HF patients
with multiple hospital admissions are labeled
“non-compliant.” As the CBCM met with patients
and reviewed data, it was discovered that very
few of MDMC’s HF patients were truly noncompliant. Most patients did not understand
their disease process or the impact of their lifestyle
on their HF. The HF patients were being educated
by staff, but there was a clear gap in the transfer
of knowledge. The team at MDMC started with
a community literacy analysis. Most of the current
teaching tools were written at an eighth grade
reading level. The analysis indicated the literacy
level around MDMC’s urban facility to be in the
lowest 10% in the nation. A review of current
literature showed the difference between “health
literacy” and literacy. High literacy level does not
directly correlate to high health literacy, which
is why an eighth grade reading level had been
19
COLLABORATIVE CASE MANAGEMENT | ACMAWEB.ORG
used previously. MDMC felt that for their patient
population, using educational material at a third
to fifth grade reading level would be more
successful in ensuring knowledge transfer. They
also felt that the educational material would need
to be simplified. There was no pre-printed teaching
material found that met the patient population’s
needs, so a subcommittee was formed to develop
a customized HF teaching booklet.
after discharge, 3) Weigh yourself every
morning and call your doctor if you gain 3
pounds in a day or 5 pounds in a week. There
are other critical topics for heart failure patients;
however, MDMC’s goal for patient education was
to give the patient a “Dixie cup portion” of
information to digest, instead of spraying them
with a “fire hose of information,” hoping they will
retain some important information.
The committee was chaired by the CBCM and
included a registered dietitian, cardiac rehab
specialist, and leadership from the telemetry
units. Over several months the committee met
and created the content for the “Guide to Heart
Failure” booklet. Content was reviewed and
approved by the cardiology physician
champion. The CBCM then took the content
and worked with the public relations
department to draft a booklet. A final draft was
reviewed by cardiology, pharmacy, nursing,
and volunteers from the older adult community
outreach program. The final booklet contains
basic information on HF, symptoms, daily weights,
medications, diet, physical activity, and physician
visits. It also engages the patient with places for
them to write questions, take quizzes and record
self-care activities after discharge. Patients are
encouraged to bring the booklet to follow-up
appointments to facilitate communication with
their primary care physician (PCP).
Challenges faced in developing educational
material were minimal. The committee agreed
easily on content and formatting based on best
practice recommendations for low literacy
health education. The only significant challenge
was time: the time necessary to secure approval
for the booklet from legal, and then the time
necessary for the hospital’s public relations
department to format and publish the booklet.
Securing support from the public relations
department leadership was instrumental in
getting the booklet published.
Training on use of the “teach back method”
of patient education was provided to all staff
in a position to teach a patient. This method of
education encourages staff to have the patient
“teach back” what they just learned, allowing
for evaluation of the education provided. An
electronic learning module was developed for
nurses and another module developed for nonRN staff, both using examples of heart failure
patient education. This module was required
for all clinical area staff and was added to their
annual core competency training. It was also
added to the new hire competency training for
all new clinical staff.
HF is a complicated disease, usually
accompanied by multiple comorbidities.
Patients are often overwhelmed with
information during their 2-3 day stay. Nurses
were taught to review all the topics in the
“Guide to Heart Failure Booklet,” but not
everything could be covered in detail. The three
pieces of information the committee felt were
the most crucial educational needs for patients
were: 1)Take your medications as prescribed
by your doctor, 2)Follow-up with your doctor
20
OUTCOMES
ABOUT THE AUTHORS
Gail Serralta, RN, BSN, CCM, CMAC,
has been Director of Care Management at
Methodist Health System since 2007. She has
more than 30 years of health care experience,
14 of which have been in case management.
During her 19 years as a nurse, she has
specialized in emergency room care and
intensive care.
Michelle Hendricks, RN, BSN, has been
at Methodist Health System since 2011. She
earned her BSN from Baylor University Louise
Herrington School of Nursing and has received
post graduate education from Johns Hopkins
Bloomberg School of Public Health. Michelle
has 10 years of combined experience in critical
care/emergency nursing, nursing education,
and case management.
REFERENCES
1
Jessup M, Abraham WT, Casey DE, Feldman
AM, Francis GS, Ganiats TG, Konstam MA,
Mancini DM, Rahko PS, Silver MA, Stevenson
LW, Yancy CW, writing on behalf of the 2005
Guideline Update for the Diagnosis and
Management of Chronic Heart Failure in the Adult
Writing Committee. 2009 Focused update: ACCF/
AHA guidelines for the diagnosis and management
of heart failure in adults: a report of the American
College of Cardiology Foundation/American
Heart Association Task Force on Practice
Guidelines. Circulation.2009;119:1977–2016.
Riegel B, Moser DK, Anker SD, Appel LJ,
Dunbar SB, Grady KL, Gurvitz MZ, Havranek EP,
Lee CS, Lindenfeld J, Peterson PN, Pressler SJ,
Schocken DD, Whellan DJ; on behalf of the
American Heart Association Council on
Cardiovascular Nursing, Council on Clinical
Cardiology, Council on Nutrition, Physical
Activity, and Metabolism, and Interdisciplinary
Council on Quality of Care and Outcomes
Research. State of the science: promoting self-care
in persons with heart failure: a scientific statement
from the American Heart Association. Circulation.
2009;120:1141–1163
3
Lindenfeld J, Albert NM, Boehmer JP, Collins
SP, Ezekowitz JA, Givertz MM, Klapholz M, Moser
DK, Rogers JG, Starling RC, Stevenson WG, Tang
WHW, Teerlink JR, Walsh MN. Executive
Summary: HFSA 2010 Comprehensive Heart
Failure Practice Guideline. J Card Fail
2010;16:475e539.
2
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