cms-proposed antibiotic stewardship rules: what you need to know

Presented by: James M. Keegan, MD

AMERICAN HEALTH LAWYERS ASSOCIATIONJUNE 29, 2016

CMS-Proposed Antibiotic Stewardship Rules:

What you need to know

Presented byJames M. Keegan, MD

Native Kingsport, Tennessee

Emory University, Atlanta, Georgia

U.S. Air Force, Ellsworth AFBSouth DakotaCommendation: Meritorious ServiceChief of Medical Staff

University of VermontInfectious 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 CityRegional Hospital and

Regional Health(Western SD)

2001-Pres Medical DirectorAntibiotic Stewardship,Rapid City Regional Hospital

2005-2013 Administrative Leadershipin Regional Health

Vice President Quality Chief Medical OfficerChief Executive Officer of Regional HealthPhysicians 1 of 5 Senior ExecutiveTeam Members

The Problem – Antibiotic ResistanceThe 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

The Problem – Antibiotic ResistanceThe 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

Historical Prescribing Practices

90-95% of all sinus infections are viral, yet…”

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

empiricaladjective | em-pir-i-kuh-l

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

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.

Message Going MainstreamGrowing Public Awareness of the Problem

“USA needs to take immediate steps to fight super bugs, experts say.”

Broad Spectrum AntibioticsUse by State

Use of Quinolones in 2012Source: IMS Xponent

MRSAIncidence by Region

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

What We Are Seeing

RESULTS

OBSERVATIONS

30-Hospital Collaborative

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 OversightTracking

Reporting

Ongoing Education

Antibiotic Stewardship

Our PhilosophyPRIMUM NON NOCERE

“Aggressive Diagnostics and

ConservativeTherapeutics”

The Role of Diagnostics

Rapid diagnostics Pay now or pay more later Prescribing contingent

upon lab results

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.”

Valley Hospital ASP ResultsC. difficile and ABX Correlation

Hospital Engagement Sample ResultsC. difficile and Antibiotics Correlation

PenicillinAllergy

• 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

Antibiotic Stewardship ProgramDirect 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)

Antibiotic Stewardship ProgramIndirect 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

Antibiotic Stewardship ProgramRelated 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

Antibiotic Stewardship equalsTriple 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.

Antibiotic Stewardship ProgramSelected 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

PYA ASP TeamOur 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

Public Health Crisis

…resistance to antibiotics has become a major threat to public health” World Health Organization

PYA’s ASP TEAMMultidisciplinary Expertise

PERSHING YOAKLEY & ASSOCIATES, P.C.800.270.9629 | www.pyapc.com

James M. Keegan, [email protected]

(605) 408-6513

mailto:[email protected]