This document summarizes a presentation on proposed CMS rules for antibiotic stewardship programs. It discusses the growing problem of antibiotic resistance and inappropriate antibiotic prescribing. It provides background on the presenter and outlines CDC core elements for antibiotic stewardship. The presentation reviews results from antibiotic stewardship programs, including reductions in C. difficile infections and antibiotic costs. It argues that antibiotic stewardship programs improve patient outcomes and safety while reducing costs.

1. Presented by:
James M. Keegan, MD
AMERICAN HEALTH LAWYERS ASSOCIATION
JUNE 29, 2016
CMS-Proposed
Antibiotic Stewardship Rules:
What you need to know

2. Page 1
Presented by
James M. Keegan, MD
Native Kingsport, Tennessee
Emory University, Atlanta, Georgia
U.S. Air Force, Ellsworth AFB
South Dakota
Commendation: Meritorious Service
Chief of Medical Staff
University of Vermont
Infectious Disease Fellowship
1986-1990 Clinical Practice of Infectious Disease
with Fred Kerns, MD, Charleston WV
1990-2005 Clinical Practice Infectious Disease
1990-Pres Medical Director of Infection Control,
Rapid City
Regional Hospital and Regional Health
(Western SD)
2001-Pres Medical Director
Antibiotic Stewardship,
Rapid City Regional Hospital
2005-2013 Administrative Leadership
in Regional Health
Vice President Quality  Chief Medical Officer
Chief Executive Officer of Regional Health
Physicians  1 of 5 Senior Executive
Team Members

3. Page 2
The Problem – Antibiotic Resistance
The Global Health Crisis
Each year in the U.S. at least 2-million
Americans will become infected with
bacteria that are resistant to antibiotics and
at least 23,000 die each year as a direct
result. CDC
By 2050, more people will die (worldwide)
from antibiotic resistance than from cancer.”
BBC

4. Page 3
The Problem – Antibiotic Resistance
The Global Health Crisis
…20-50% of all antibiotics prescribed in U.S.
acute care hospitals are either unnecessary or
inappropriate.”
Similar to the findings in hospitals, studies have
shown that 40–75% of antibiotics prescribed in
nursing homes may be unnecessary or
inappropriate.”
“We can either work to improve antibiotic use and prevent infections,
or watch as the clock turns back to a world where simple infections kill people.”
Tom Frieden, CDC

5. Page 4
Historical Prescribing Practices
90-95% of all sinus infections
are viral, yet…”

6. Page 5
Empiric Prescribing and Risks
At community hospitals, ONE of THREE
patients with bloodstream infections given
inappropriate therapy.” Duke University
: Treatment given without knowledge of cause or nature of
disorder and based on experience, rather than logic.
Simple Definition of EMPIRICAL
empirical
adjective | em-pir-i-kuh-l

7. Page 6
The Dilemma for Physicians
Patient Expectations
 Prescribed antibiotic validates
illness
 Antibiotic often considered a
“cure all”
 Patient satisfaction scores
Physicians prescribe how they
have been historically trained
Treating the patient vs. solving
world issues

8. Page 7
Regulatory Environment
Infectious Diseases Society of America (IDSA)
& Society for Healthcare Epidemiology of
America (SHEA) recommend antibiotic
stewardship as a Condition of Participation
by December 2017 to Centers for Medicare &
Medicaid Services (CMS)”
CMS Requirement Imminent?
IDSA and SHEA letter to CMS, March 4, 2014.

9. Page 8
Message Going Mainstream
Growing Public Awareness of the Problem
“USA needs to take
immediate steps to fight
super bugs, experts say.”

10. Page 9
Broad Spectrum Antibiotics
Use by State
Use of Quinolones in 2012
Source: IMS Xponent

11. Page 10
MRSA
Incidence by Region

12. Page 11
There is a disconnect--why?
• Changing clinical behavior is difficult
• Limited Antibiotic Stewardship experience
• Broadcasting the problem does not equate with solving
the problem
• Pharmacy champions and
others may not be
comfortable with task of
changing physician
prescribing behavior

13. Page 12
What We Are Seeing
RESULTS
OBSERVATIONS
30-Hospital Collaborative

14. Page 13
CDC Core Elements
13 Centers for Disease Control and Prevention, CDC, “Core Elements of Hospital Antibiotic Stewardship Programs.”
Leadership
Commitment
Accountability
Need Drug
Expertise
Active
Oversight
Tracking
Reporting
Ongoing
Education
Antibiotic Stewardship

15. Page 14
Our Philosophy
PRIMUM NON NOCERE

16. Page 15
The Role of Diagnostics
 Rapid diagnostics
 Pay now or pay more later
 Prescribing contingent
upon lab results

17. Page 16
Clostridium difficile (C.difficile)
Thoughts about this HAI
CDC Hazard Level Rank: Urgent Threat Assessment – Highest
level
 DEADLY: “Contracting C. diff drastically reduces your chance of
leaving the hospital alive. If two patients come into the hospital with
the same diagnosis, the one who gets C. difficile is four times more
likely to die.”
 EXPENSIVE: $10K per incidence (national average)
“I know that today I had 3 rooms closed down for C.diff. Meaning the patients
had discharged and the rooms steri-misted. Still have to confirm they're clean
before reopening them to accept patients. Normally takes 72 hours, depending
on when environmental services get there to steri-mist it.”

18. Page 17
Valley Hospital ASP Results
C. difficile and ABX Correlation

19. Page 18
Hospital Engagement Sample Results
C. difficile and Antibiotics Correlation

20. Page 19
Penicillin
Allergy
• If you are hospitalized and declare a penicillin allergy,
your mortality risk doubles if you are prescribed an
alternative medication
• Avoiding penicillin means using alternatives that are less
effective, more expensive, or have greater side effects
• Add length-of-stay increase
• Dangers for those/Treatment risk for those who think
they are allergic

21. Page 20
Antibiotic Stewardship Program
Direct and Attributable Financial Benefits
20-50% reduction in total antibiotic expense with
emphasis on broad spectrum antibiotics. Clinical
improvement to more precise prescribing practices.
Reduce expenses associated with antibiotic inventory
and related costs of maintaining inventory
Decrease C. difficile cases - 10% mortality rate and $10K
per incidence cost associated with this HAI (national
average)

22. Page 21
Antibiotic Stewardship Program
Indirect Financial Benefits
Savings and improved outcomes that
influence Value-Based Reimbursements
• Avoids Unnecessary Admissions
• Decreases LOS (Length of Stay)
• Decreases Readmissions
• Reduces Risk for HAI (Hospital-Acquired
Infections)
• Improves DRG Sufficiency

23. Page 22
Antibiotic Stewardship Program
Related Benefits
Public Relations and Improved
Perceptions
Better Patient Care
Mitigate Legal Risk
Prepare for impending CMS
Condition of Participation
related to the adoption of ASPs

24. Page 23
Antibiotic Stewardship equals
Triple Aim
1. Improves Patient
Care and Outcomes
2. Reduces Costs
3. Improves Health of a
Community
…and it is Simply the Right Thing to Do.

25. Page 24
Antibiotic Stewardship Program
Selected Programs and Savings
Location/Type of
Facility
Number of
Beds
Cost
Savings/Reductions
AS Team Composition
Monroe, LA
Community Hospital
120 $177,000/ 1 Year ID Specialist,
Clinical Pharmacist
Dallas, TX
LTAC Hospital
60 $159,580/ 15 Months ID Specialist,
Director of Pharmacy
Dorchester, MA
Community Teaching
Hospital
159 $200,000-250,000/
1 Year
ID Specialist,
ID-trained Pharmacist
Baltimore, MD
Large Tertiary Care,
Teaching Medical
Center
800 $2,949,705/ 3 Years ID Specialist,
Clinical Pharmacist
Winston-Salem, NC
Academic Medical
Center
880 $920,070 to $2,064,441
per year over 11 years
2 ID Specialists,
3 Clinical Pharmacists

26. Page 25
PYA ASP Team
Our Services
 24/7 Access and Support of Infectious Disease Physician and
Team
 20+ Years of ASP Experience with Proven Results
 Training and Empowerment of Physician and Pharmacy
Champions
 Concurrent Monitoring of Prescribing Practices
 Ongoing Review and Data Analysis to Ensure Continued
Success
 Transparent Reporting and Outcomes
 Safety Bundle Recommendations

27. Page 26
Public Health Crisis
…resistance to antibiotics has become
a major threat to public health”
World Health Organization

28. Page 27
PYA’s ASP TEAM
Multidisciplinary Expertise

29. PERSHING YOAKLEY & ASSOCIATES, P.C.
800.270.9629 | www.pyapc.com
James M. Keegan, MD
mkeegan@pyapc.com
(605) 408-6513