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12/6/2012 1 What’s New For Infection Preventionists In the Public Policy Arena? Lisa Tomlinson, MA Sr. Director of Government Affairs Nancy Hailpern Director of Regulatory Affairs December 6, 2012

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12/6/2012

1

What’s New For Infection Preventionists

In the Public Policy Arena?

Lisa Tomlinson, MA

Sr. Director of Government Affairs

Nancy Hailpern

Director of Regulatory Affairs

December 6, 2012

12/6/2012

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Where are your joining us from?

Overview

• Public Policy Overview

• National Action Plan to Prevent HAIs

• Regulatory Issues

• Federal Legislative Issues

• Keeping Up-To-Date on Public Policy Announcements

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Public Policy Overview

Federal

Legislation

Federal

Regulations

State

Legislation

Public Policy Committee

Patty Gray, RN, BAHSA, CIC, Chair

Annemarie Flood, RN, BSN, CIC, Vice Chair

Linda R. Greene, RN, MPS, CIC, Board Liaison

Heather M. Gilmartin, RN, MSN, FNP, CIC

Susan M. Kraska, RN, CIC

Pat Kulich, RN, CIC

Charlene Ludlow, RN, MHA, CIC

Patricia J. Metcalf, RN, MA, CIC

Patricia A. Rosenbaum, RN, CIC

Regulatory Review Panel

Theresa A. Cain, RN, BSN

Tracy Cox, RN, CIC

Susan A. Dolan, RN, MS, CIC

Shannon Oriola, RN, BSN, CIC, COHN

Rachel L. Stricof, MT, MPH, CIC

Chapter Legislative Representatives

2012 Public Policy Committee

and Regulatory Review Panel

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National Action Plan to Prevent Healthcare-

Associated Infections: Roadmap to Elimination

National Action Plan to Prevent HAIs

Update

• Phase I: Acute Care Hospitals

– HHS Action Plan to Prevent HAIs issued: 2009

– Progress report on targets and metrics presented: November 27, 2012

• Phase II: ASC, ESRD, HCP Flu Vaccination

– Update to Action Plan included these settings: 2010

• Phase III: Long-Term Care Facilities (focus on nursing homes)

– LTCF draft issued for public comment: April 2012

– Revised National Action Plan with LTCF chapter: late 2012/early 2013

• Phase IV: To be determined

– All outpatient settings? Physicians offices? Injection safety?

– HHS Steering Committee must approve the expansion

HAI Action Plan to be Maintained as a “Living” Document

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Source: HHS, Progress Toward Eliminating Healthcare-Associated Infections meeting, November 27, 2012

http://www.hhs.gov/ash/initiatives/hai/nationaltargets/index.html

NAPHAI Phase II: NAPHAI Phase II:

Measurable Goals for ASCsMeasurable Goals for ASCs

• By December 31, 2013, HHS, with stakeholder input, will:

– Develop plan for ongoing collection, electronic transmission, and analysis of process

measure data that are collected using the Infection Control Worksheet as part of ASC

inspections

– Identify existing quality measures (e.g., serious reportable events, SCIP measures)

that have been NQF-endorsed and are applicable to ASCs;

– Identify areas where additional quality measures are needed for ASCs; and;

– Establish a timeline and methods for adoption and implementation of select

measures within ASCs

– Identify a set of ASC procedures for which HAI definitions and methods should be

developed; and,

– Establish a multi-year plan and phased approach to support their routine surveillance

in a resource-efficient matter that can be implemented consistently across facility

types; and,

– Identify requirements and standards for ASCs to report notifiable diseases and

potential outbreaks.

Source: HHS, Progress Toward Eliminating Healthcare-Associated Infections meeting, November 27, 2012

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NAPHAI Phase II: NAPHAI Phase II:

HCP Influenza ImmunizationHCP Influenza Immunization

• Increasing Influenza Vaccination Among Healthcare Personnel (HCP) – by December 31,

2015 achieve 75% vaccination of HCP

• Interim goal

• Healthy People 2020 Goal for annual influenza vaccine coverage for HCP is 90%

NAPHAI Phase II: NAPHAI Phase II:

EndEnd--Stage Renal Disease Facilities (ESRD)Stage Renal Disease Facilities (ESRD)

• End-Stage Renal Disease Facilities (ESRD) – by December 31, 2015 achieve specified

ESRD HAI reduction measures and goals (measured by NHSN and CrownWeb)

• Prevention Priorities:

– Prevention of Intravascular Infections

– Prevention of Bloodborne Pathogen Transmission

– Prevention of Influenza and Pneumococcal Disease

– Prevention Priority Implementation Bundles

– Education and Training

• Five-Year National Metrics and Evaluation Targets:

http://www.hhs.gov/ash/initiatives/hai/esrd.html

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Priority areas:

• National Healthcare Safety Network (NHSN) enrollment

− Goal: 5% of certified nursing homes enroll in NHSN over the 5 years following

launch of the component

• Resident Influenza and Pneumococcal Vaccination

‒ Goal: 85% vaccination coverage of eligible residents for both seasonal

influenza and pneumococcus

• HCP Influenza Vaccination

‒ Goal: 75% of HCP in LTC receiving the seasonal influenza vaccination by 2015

based on National Health Interview Survey data

• Urinary Tract Infections (UTI)

‒ Goal: Pilot reporting to NHSN, evaluate variability, and obtain consensus on

measurable 5-year targets

• Clostridium difficile infections (CDI)

‒ Goal: Pilot implementation of reporting to NHSN, evaluate variability in

measure and obtain consensus on a measurable 5-year target

National Action Plan to Prevent HAIs

Phase III – Draft LTCF Module

Regulatory Issues

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• Ban on the Extralabel Use of Cephalosporins In Food-Producing Animals

• Proposed Regulation on a Veterinary Feed Directive (VFD)

• Guidance on Judicious Use of Antimicrobial Drugs in Food-Producing Animals

• Guidance on Drugs Administered in Food or Drink of Food-Producing Animals

• Unique Device Identifiers

• Infection Control Surveyor’s Worksheet

• Electronic Health Record Incentive Program – Stage 2

• Hospital Inpatient and Long-Term Care Prospective Payment System

• Hospital Outpatient and Ambulatory Prospective Payment System

• Revised Physician Fee Schedule Proposed Rule

• End-Stage Renal Disease Prospective Payment System Rule

• Healthcare Personnel Influenza Vaccination Goals for Healthy People 2020

• Certification Criteria for Electronic Health Record Technology

• National Action Plan to Prevent HAIs – Revisions to Tiers 1 and 2

• National HAI Action Plan Long-Term Care Module

2012 Regulatory Action

http://www.apic.org/Advocacy/Government-Affairs-Resources

Healthcare Facility Reporting to CMS via

NHSN: Current and Proposed Requirements

HAI Events Facility Type Reporting Start Date

CLABSIs Acute Care Hospital ICUs Jan 2011

CAUTIs Acute Care Hospital ICUs (except

NICUs)

Jan 2012

SSIs Colon Surgeries and Abdominal

Hysterectomies

Jan 2012

Dialysis Events Dialysis Facilities Jan 2012

CLABSIs Long Term Care Hospitals Oct 2012

CAUTIs Long Term Care Hospitals Oct 2012

CAUTIs Inpatient Rehab Facilities Oct 2012

MRSA Bacteremia LabID Events Acute Care Hospitals Jan 2013

C Difficile LabID Events Acute Care Hospitals Jan 2013

HCP Influenza Vaccination Acute Care Hospitals Jan 2013

HCP Influenza Vaccination Long Term Care Hospitals Oct 2013

HCP Influenza Vaccination Ambulatory Surgical Centers Oct 2014

SSIs and other events ASCs and Hospital Outpatient Depts TBD

• Long Term Care Hospitals are called Long-Term Acute Care Hospitals in NHSN

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• APIC submitted comments to CMS on infection control provisions in proposed

updates to payment systems impacting:

– hospital inpatients

– hospital outpatients

– ASCs

– LTCFs

– ESRDs

– inpatient rehabilitation facilities, and

– physicians

• Common themes include:

– Efforts to align quality reporting measures across programs and healthcare

settings

– Efforts to reduce reporting burden for healthcare providers

– Efforts to reduce hospital readmissions

– Use of subregulatory process for non-substantive updates to adopted measures

– Automatic continuation of adopted measures unless CMS proposes to remove,

suspend or replace measure

CMS Payment Systems

• New: Hospital Value-Based Purchasing (VBP) program incorporated into

Hospital Inpatient Quality Reporting (IQR) Program

– VBP: incentive payments to hospitals based on performance scores

determined by formula of clinical process of care of care measures +

patient experience of care measures.

• VBP process measures taken from measures already adopted for

Hospital IQR Program.

– New: For FY 2015, outcome measures CLABSI and AHRQ Patient

Safety Indicator (PSI)-90 composite added to the VBP performance

score formula

Value-Based Purchasing (VBP)

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• No new HAI reporting requirements for acute care hospitals for reporting

beginning after 2013.

• Addition of 2 new hospital-acquired conditions (HACs) in FY 2013 (starts

October 2012):

– SSI following cardiac implantable electronic device (CIED)

– Iatrogenic pneumothorax with venous catheterization

• Removal of 8 original HACs from Hospital Inpatient Quality Reporting

(IQR) Program beginning FY 2015 (starts October 2014).

– Includes CAUTI, vascular catheter-associated infection, and certain SSIs

– HAI-HACs removed because they overlap with NQF-endorsed CAUTI and

CLABSI reporting measures already included in IQR

– Other HACs also overlap with other measures in IQR

Acute Care Hospitals

• New PPS-Exempt Cancer Hospital Quality Reporting Program

– New: NHSN reporting of CLABSI (ICU and non-ICU) and CAUTI for FY 2014.

• Quarterly reporting beginning with October 2012 events.

Cancer Hospitals

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• Long-Term Care Hospital Quality Reporting (LTCHQR) Program

– NHSN reporting of CLABSI and CAUTI already adopted for FY 2015 payment

• Reporting begins October 2012

– New: HCP Influenza Vaccination reporting for FY 2016 payment

• Reporting begins October 2013

Long-Term Acute Care Hospitals

• No new HAI quality reporting measures beginning after 2014.

• Hospital OQR validation requirements

– CY 2012: 800 randomly selected hospitals for validation of chart

abstracted data.

– CY 2013: number of hospitals reduced to 450.

– New: CY 2014 – 450 randomly selected hospitals for validation of chart

abstracted data (Same as 2013).

• HCP influenza vaccination for ASCs for CY 2016 payment determination

– Reporting via NHSN begins 10/1/14 – 3/31/15.

Hospital Outpatient/ASCs

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• CAUTI measure for IRF Quality Reporting Program

– CAUTI rate per 1,000 urinary catheter days.

– New: Updated to use different calculation method -- standardized

infection ratio (SIR) (still reported through NHSN).

Inpatient Rehabilitation Facilities

• Vascular Access Type

– Payment Year (PY) 2015: CMS continuing previously-adopted measures to

maximize use of arteriovenous fistulas (AVF) and minimize use of catheters.

• Drug policy changes: Daptomycin

– Calendar year (CY) 2012: CMS eliminated restrictions on vancomycin to allow

ESRD facilities to receive separate payment for claims when furnished to treat

ESRD and non-ESRD related conditions, such as skin infections.

– New: CY 2013: CMS expanded this to include daptomycin.

End-Stage Renal Disease Facilities

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• NHSN Dialysis event reporting measure

– Adopted 2011: CMS required enrollment and training in NHSN, and submission of

3 or more consecutive months of dialysis event data to NHSN for PY 2014.

Reporting began January 2012.

– New: CMS expanded reporting period to 12 months of dialysis data for PY 2015.

• All data for 12-month reporting period must be reported to NHSN no later

than 4/15/14.

– Bloodstream infection measure: NQF measure #1460

• Already exists in NHSN for dialysis event reporting, but until now the CMS

ESRD measure only assessed facilities based on whether they enroll and

report dialysis event data to NHSN, not on what the data reported are.

• New: CMS intends to propose to adopt NQF #1460 once facilities have more

experience reporting data – sometime after PY 2015.

End-Stage Renal Disease Facilities (con’t)

• Data validation

– Beginning CY 2013, CMS will begin a pilot data validation program in which

they will randomly sample data from approximately 750 facilities,

approximately 10 records per facility.

– First year: no facility will receive payment reduction.

– Future years: facilities will be scored based on accuracy, with payment

reduction if data incorrect beyond certain threshold.

End-Stage Renal Disease Facilities (con’t)

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Annual update to payment policies under Medicare Part B (physician fee schedule)

• Includes Physician Quality Reporting System – holds physicians accountable to

provide quality care

– Some infections included in PQRS measures.

– Composite of acute prevention quality indicators -- includes bacterial pneumonia,

UTI, and dehydration

• All-cause readmission

– Rate of provider visits within 30 days of discharge from acute care hospital per

1,000 discharges.

– CMS Intent:

• incentive for groups to focus on reducing hospital readmissions.

• incentive for physicians to engage in more effective care coordination.

Physician Payment

Federal Legislative Issues

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APIC Support for

Federal Programs

• Centers for Disease Control and Prevention Core Programs

– National Healthcare Safety Network (NHSN)

– Emerging Infections Program (EIP)

– Antimicrobial stewardship programs

• National Action Plan to Prevent HAIs

• Agency for Healthcare Research and Quality (AHRQ)

– Comprehensive Unit-based Safety Program (CUSP)

Annual Funding for Programs

Related to Infection Prevention

• APIC and SHEA jointly outline our organizations’ annual

funding priorities and submit testimony to the House and

Senate Appropriations Committees.

• Meet with Appropriations Committee staff.

• Prepare materials so that

our members can send

letters to their legislator at

the key times.

• Participate in Coalition

activities that promote

these priorities.

Joint APIC-SHEA Congressional Testimony

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Taking Action: Be A Voice

For Infection Prevention

• This is where

Members can

take action on

APIC Action

Alerts

• Most federal programs operating under a continuing

resolution through March

– Differences between House and Senate funding levels still need to be

worked out

• Congress needs to act or spending for “domestic

discretionary” programs will be cut by an estimated 8%

– Automatic cut for CDC would be an estimated $490 million

Federal Funding for 2013 Uncertain

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Antimicrobial Resistance

Actions in Congress

• Generating Antibiotics Incentives Now (GAIN) Act passed as part of the Food and Drug

Administration Reauthorization (Public Law 112-144)

– Creates incentives to encourage the development of products to treat, prevent,

detect and diagnose antibiotic-resistant infections

– Extends the length of time an approved drug is free from competition

• Strategies to Address Antimicrobial Resistance Act (STAAR) Act language was included

in FY13 Senate Appropriations Report – related bill not yet enacted (S. Rept. 112-176)

– Asks for a report from CDC in coordination with the Interagency Task Force on

Antimicrobial Resistance (ITFAR) on the type and scope of data collected in the US

on antibiotic consumption and resistance trends, a comparison of this level of data

with the level and scope of data collected around the world, and the benefits or

drawbacks of collecting such data

– Calls on the HHS Secretary to designate an office and director to lead the task force

and coordinate the federal response

Antimicrobial Resistance

Actions in Congress

Limited Population Antibacterial Drug Approval (LPAD) Mechanism:

• IDSA proposed new antibacterial approval mechanism

• For drugs to treat serious or life-threatening infections for which few or no satisfactory

drug options exist

• Safety and effectiveness would be studied in smaller, more rapid, and less expensive

clinical trials – like the orphan drug programs permits for other diseases

• Products would be narrowly indicated for use in small, well-defined populations of

patients for whom the drugs’ benefits outweigh their risks

• Product labeling designed to ensure that these drugs are narrowly marketed for use in

the limited population

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• U.S. House of Representatives Energy and Commerce,

Oversight and Investigations Subcommittee

– The Fungal Meningitis Outbreak: Could It Have Been Prevented?

• U.S. Senate Committee on Health Education Labor and

Pensions

– Pharmacy Compounding: Implications of the 2012 Meningitis Outbreak

Meningitis Outbreak

Keeping Up-to-Date on

Public Policy

Announcements

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Public Policy Action EPublic Policy Action E--ListList

• Alerts you to the latest Public Policy news as soon as it is

available.

• Links to additional information on APIC’s website.

• Let’s you know when critical action is needed on the latest

infection prevention policy issues.

Sign-up here to join the list

Where Can You Find the

Latest Public Policy News?

• The “Public Policy:

What’s New” page

provides the latest

updates.

www.apic.org/Advocacy/Advocacy-Updates

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Where Can You Find Other

Public Policy Resources?

• This is a library of a

wide range of Public

Policy resources. For

example:

– Federal

regulations

– APIC comments

on federal

regulations

– APIC testimony to

Congress

– Congressional

hearings

For example, this is the

CMS page, which includes

for each issue:

• Proposed rule

• APIC comments

• Final rule

Sample Agency Page: CMS

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Where Can You Find State and

Federal Legislative Updates?

• This is where you can

check for legislative

updates for specific

states and/or by

issues we follow

• Options:

– click on a specific

issue

– choose a state

from the pull-

down menu

– click on a specific

state on the map

Sample State Bill Summary: KYSample State Bill Summary: KY

• This is what you see

when you click on a

state on the website.

• Within state or issue,

you can read about

bills we’re following

• Link to read bill itself

• Summary provided

by CQ

• Summary added by

APIC

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• With the help of the Greater St. Louis Chapter, APIC released a toolkit

developed to help APIC chapters reach out to state policymakers

• The toolkit will include:

� Tips for planning a legislative visit

� Tips for preparing materials

� Sample planning timeline

� Sample meeting request letters

� Sample talking points

� Sample follow-up letters

Voice for Infection Prevention (VIP)

Advocacy Toolkit:

http://www.apic.org/Advocacy/advocacy-toolkit

AHRQ – Agency for Healthcare Research and Quality

ASC – Ambulatory Surgical Center

CDC – Centers for Disease Control and Prevention

CLIP – Central Line Insertion Practices

CLR – APIC Chapter Legislative Representative

CMS – Centers for Medicare & Medicaid Services

CUSP – Comprehensive Unit-based Safety Program at AHRQ

CY – Calendar Year

DRG – Diagnosis Related Group

EIP – Emerging Infections Program at CDC

ESRD – End-Stage Renal Disease

FDA – Food and Drug Administration

FY – Fiscal Year

GAIN Act – Generating Antibiotic Incentives Now (GAIN) Act

GAO – Government Accountability Office

Acronyms and Abbreviations

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HAC – Hospital-Acquired Condition

HCP – Healthcare Personnel

HCUP – Healthcare Cost and Utilization Project

IIPW – International Infection Prevention Week

IPPS – Hospital Inpatient Prospective Payment System

IRF – Inpatient Rehabilitation Facility

IDSA – Infectious Diseases Society of America

IQR – Hospital Inpatient Quality Reporting Program

ITFAR - Interagency Task Force on Antimicrobial Resistance

LPAD – Limited Population Antimicrobial Drug Approval

LTCF – Long-term care facility

LTCH – Long-term care hospital

NAPHAI – (HHS) National Action Plan to Prevent HAIs: Roadmap to Elimination

NHSN – (CDC’s) National Healthcare Safety Network

NQF – National Quality Forum

Acronyms and Abbreviations

OPPS – Hospital Outpatient Prospective Payment System

OQR – Hospital Outpatient Quality Reporting Program

QIP – Quality Incentive Program

PY – Payment Year

SCIP – Surgical Care Improvement Project

STAAR Act – Strategies to Address Antimicrobial Resistance Now Act

VBP – Value-Based Purchasing

VIP – Voice for Infection Prevention

Acronyms and Abbreviations

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Questions?

[email protected]

To complete the program evaluation,

please click the following link:

http://www.magnetmail.net/forms/display_form.cfm?uid=

CPClient&fid=34171&rtype=nonmm

To obtain your participation certificate,

http://webinars.apic.org/evaluation/index.php?id=9762

and enter the certificate code below: 22Rh3n

12/6/2012

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