what’s new for infection preventionists in the public...
TRANSCRIPT
12/6/2012
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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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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?
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