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2012 Updates: SCPC Troponin Turn-Around-Time Documentation Requirements and CMS OP-16 1

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Page 1: 2012 Updates: SCPC Troponin Turn-Around-Time …SCPC Troponin Turn-Around-Time Documentation Requirements and CMS OP-16 1 . ... III and/or pink Tier IV Items: 4.4.0.0 Yes No Item Baseline

2012 Updates: SCPC Troponin

Turn-Around-Time Documentation Requirements

and CMS OP-16

1

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Speaker Overview

Ruth Cantu, BSN, RN Accreditation Review Specialist

There are no disclosures

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Objectives

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Discuss turn-around-time (TAT) implications in healthcare studies, research and guidelines

Discuss the Society of Chest Pain Centers (SCPC) Troponin Turn-around-Time (TTAT) documentation

requirements for accreditation

Provide an update of the Centers for Medicare and Medicaid Services (CMS) Hospital Outpatient Quality Data

Reporting Program: OP-16

Discuss best demonstrated practices for improvement in process outcomes

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Society of Chest Pain Centers

Patient-centric

Founded in science

Validated by accreditation and certification

The leader in establishing criteria helping hospitals develop superior processes that embrace

the full spectrum of cardiac care by providing tools, education and support to drive process improvement in

healthcare facilities worldwide.

We create communities of excellence that share understanding on quality, cost and patient satisfaction.

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Benefits of SCPC Accreditation

Streamlines and standardizes intra/inter-facility processes from identification of symptoms to definitive care

Requires defined pathways to reduce missed MIs through a consistent approach to risk stratification of the ACS patient

Promotes evidence-based processes that result in improved quality outcomes and improves performance on quality indicators

Requires everyone who touches the cardiac patient to come together; breaking down silos that exist between disciplines and departments

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Society of Chest Pain Centers

Cardiac Biomarkers &

Troponin Turn-Around-Time

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Changing Perspectives of Turn-Around-Time Tracking and Healthcare Implications

Recent studies and research support the movement towards the following:

Assessing the “whole process” (ie: arrival)

Standardizing definitions of TAT

Assessing TAT with patient outcomes and length of stay

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Changing Perspectives of Turn-Around-Time Tracking and Healthcare Implications

Study by Ervasti et al, Clin Chem Lab Med 2008

Proposed new concepts for TAT in the diagnostic process: As a “Patient-oriented” view or the “whole process”

Diagnostic TAT – arrival to reporting of results (outcomes median 122 min)

Clinical TAT – arrival to order Laboratory TAT – order to report/resulted

In Academic Emergency Medicine, 2010:17, Hwang et al noted: “Guidelines do not exist delineating times frames for when a troponin test should

optimally be resulted in association with improved patient outcomes.”

“ Prolonged laboratory TAT may delay recognition of conditions in the acutely ill , potentially affecting clinician decision-making and the initiation of timely treatment.” Outcomes median 107 minutes; “ordered to resulted”

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SCPC Cardiac Biomarker Requirements

Measuring TAT is a guideline driven recommendation

No previous TAT requirement SCPC requirement starting in 2012

Track and demonstrate improvements

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Page 10: 2012 Updates: SCPC Troponin Turn-Around-Time …SCPC Troponin Turn-Around-Time Documentation Requirements and CMS OP-16 1 . ... III and/or pink Tier IV Items: 4.4.0.0 Yes No Item Baseline

Troponin Measurement

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0.8% Tn / MYO

39.3% Tn / CKMB

23.0% Tn/ CKMB / MYO

14.5% Diff combo

22.2% Tn only

Which do you measure in your lab/hospital today?

Troponin (Tn) and MyoglobinTroponin and CK-MBTroponin, CK-MB and MyoglobinA different combination of markersTroponin only

CLN – April 2009, vol 35, no 4

Troponin TAT only

Gold standard

Standardization

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The facility has a process for reviewing and assessing baseline troponin quality metrics for ED patients. These metrics are tracked and shared between the ED and laboratory at appropriate committee meetings at least quarterly. At least six months of metrics are required AND at least two of the following green Tier III and/or pink Tier IV Items:

4.4.0.0

Yes No Item Baseline troponin “turnaround time" (TAT) is broken down into the

time segment of ORDER to COLLECT. 4.4.1.0

Baseline troponin TAT is broken down into the time segment of COLLECT to RECEIVE IN LAB.

4.4.2.0

Baseline troponin TAT is broken down into the time segment of RECEIVE IN LAB to RESULT.

4.4.3.0

Baseline troponin TAT is broken down into the time segment of DOOR to RESULT.

4.4.4.0

Baseline troponin TAT is broken down into the time segment of DOOR to ORDER.

4.4.5.0

Baseline troponin TAT is broken down into the time segment of ORDER to RESULT.

4.4.6.0

Baseline troponin TAT is broken down into the time segment of COLLECT to RESULT.

4.4.7.0

90% of baseline troponin TAT of ORDER TO RESULT or COLLECT to RESULT is within 60 minutes.

4.4.8.0

Yes No Item 90% of baseline troponin TAT of ORDER to

RESULTS or COLLECT to RESULT is within 30 minutes.

4.4.9.1

Item The facility's cardiac biomarker approach includes documentation of an evidenced-based serial troponin strategy that is consistent with the assay used AND at least one of the following green Tier III Items:

4.5.0.0

Yes No Item The facility has a process in place to monitor the TAT of serial

draws for troponin. 4.5.1.0

The cardiac biomarker protocol includes a serial troponin from ED arrival up to 6 hours. The protocol may last less than 6 hours if provocative cardiac testing or imaging takes place.

4.5.2.0

SCPC Tool Example

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SCPC ACCREDITATION & BIOMARKER TESTING: Key Element 4 – 4.4.0.0 overview

Demonstrating a process for reviewing and assessing Troponin TAT for Emergency Department (ED) patients

Documentation requirements: Monthly or quarterly meeting notes Lab participates as an agenda item Metrics, process and action plans discussed

Minimum 6 months of data Goal times Required to provide TAT metrics: cumulative & secondary Point-of-Care Testing (POCT) Central Laboratory Analyzers

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SCPC ACCREDITATION & BIOMARKER TESTING: Key Element 4

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KE 4.4.0.0

POC in ED? IF NO IF YES

CUMULATIVE TAT CUMULATIVE TAT

AND AND

SECONDARY TAT % compliance

(90% C-R in 60’) SECONDARY TAT

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Where does Point-of-Care Testing (POCT) fit in with CP Accreditation?

“To the extent that laboratory test TAT is only one factor impacting

ED length of stay and patient outcomes,

it is unlikely that POCT alone, in the absence of an interdepartmental approach to ED operations,

will produce measurable improvements in outcomes.”

Lewandrowski, E. et al. Cardiac Marker Testing As Part Of An

Emergency Department Point-of-Care Satellite Laboratory In A Large Academic Medical Center. Practical Issues Concerning Implementation. Point of Care. The Journal of Near Patient testing & Technology. Vol. 1,

No.3, pp. 145-154.

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SCPC ACCREDITATION & BIOMARKER TESTING: Key Element 4

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KE 4.4.0.0

POC in ED? IF NO IF YES

CUMULATIVE TAT CUMULATIVE TAT

AND AND

SECONDARY TAT % compliance

(90% C-R in 60’) SECONDARY TAT

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CBM TAT EXAMPLE COLLECTION TOOL: 90% Goal w/in 60 minutes

Total (n=ED TnI)

# Collect to Result w/in

60 min

Collect-Result

<=60 min (=C/B) Goal

January 522 479 92% 90%February 554 453 82% 90%March 590 522 88% 90%April 520 477 92% 90%May 517 468 91% 90%June 507 471 93% 90%July 544 514 94% 90%August 473 440 93% 90%September 491 452 92% 90%October 534 484 91% 90%November 494 435 88% 90%December 490 463 94% 90%Totals: 6236 5658 91% 90%

Example: Troponin TAT

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4.4.7.0

4.4.8.0

Year:____

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DATA SUBMISSION OPTIONS

College of American Pathologist (CAP) QM1 monitor

The Society has partnered with the College of American Pathologist who have created a validation tool which collects data to meet the Society requirements for TAT tracking.

Additional benefits are having one source collecting data for research to track the “diagnostic TAT” or “door to result’ data through sampling.

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SCPC ACCREDITATION & BIOMARKER TESTING: Key Element 4

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4.5.1.0 – The facility has a process in place to monitor the TAT of serial draws for Troponin

Key concept: “Windows of Scheduled Time”

•Assessment and documentation of serial draw time points

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SCPC Summary

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Information is current as of 7/1/2012: SCPC KE 4.4.0.0

Troponin TAT tracking requirement? YES

Accreditation for PCI/Non-PCI

Admission/Disposition status dependant? NO

All ED baseline Troponin

Can use validation tools? YES

CAP QM1 monitor

Requires “door to result in 60 minutes”? NO

One cumulative (door/order/collect) and one secondary time-point; TAT goals must

be set by facility

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SCPC Summary

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Information is current as of 7/1/2012: SCPC KE 4.4.0.0

Requires % compliance? YES For POC, 90% collect-to-result in 60 min;

can also apply for main lab.

Includes PCI Hospitals? YES All facilities applying for

Chest Pain Accreditation

Includes Non-PCI Hospitals? YES

All facilities applying for Chest Pain Accreditation

Includes Critical Access Hospitals? YES

All facilities applying for Chest Pain Accreditation

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Summary

Expectations and documentation requirements include:

TAT tracking for POC or central lab analyzers

Laboratory participation in meetings, at least quarterly

Metrics broken down into different time points with clear definitions of starting and end point goals and include: The number (n) of cases by month Data minimum: six months Policies for tracking of serial time-points

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DISCLAIMER

CMS and OP-16 : Information and opinions included in this presentation

are based on interpretation of currently available regulatory resources.

No representation is made as to the completeness of the information.

Please refer to specific regulatory guidelines, hospital coding/billing or quality department as necessary for the latest updates.

The following information is derived from research of various sources, to include but not limited to the following:

CMS, Qualitynet.org, the Federal Register, QIO, industry guidance documents and industry representatives

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Hospital Inpatient Quality Data Reporting Program Summary from Inpatient Prospective Payment System- Final Rule

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INPATIENT Current and Proposed Measures Collected and Submitted by Hospital

HIQRP* VBP**

MEASURE Reporting effective

date Affects

APU

Reporting effective

date

Affects Reimburse

ment Acute Myocardial Infarction (AMI)

AMI-1 Aspirin at arrival *Ended

2011 *Retire FY 2014

AMI-2 Aspirin prescribed at discharge Ongoing Ongoing

AMI-3 Angiotensin Converting Enzyme Inhibitor (ACE-I) or Angiotensin II Receptor Blocker (ARB) for left ventricular systolic dysfunction

*Ended 2011

*Retire FY 2014

AMI-4 Adult smoking cessation advice/counseling *Ended

2011 *Retire FY 2014

AMI-5 Beta blocker prescribed at discharge *Ended

2011 *Retire FY 2014

AMI-7a Fibrinolytic (thrombolytic) agent received within 30 minutes of arrival Ongoing Ongoing July 2011 FY 2013

AMI-8a Timing of Receipt of Primary Percutaneous Coronary Intervention (PCI) Ongoing Ongoing July 2011 FY 2013 AMI-10 Statin prescribed at discharge Jan 2011 FY 2013 Emergency Department (ED)

Heart Failure (HF)

Pneumonia (PN)

Stroke

Surgical Care Improvement Project (SCIP)

Venous Thromboembolism (VTE)

Global Immunizations

*HIQRP - Hospital In-patient Quality Reporting Program

**VBP - Value Based Purchasing Program

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Hospital Outpatient Quality Data Reporting Program Summary from Outpatient Prospective Payment System (OPPS) - Final Rule

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Measure # Measure Short Name: CY2012, CY2013, CY2014 Payment Determination HOSPITAL COMPARE TJC ORYX Effective Collection MEASURE SET:

OP-1 Median Time to Fibrinolysis NO YES Ongoing Abstract AMI / SCPC OP-2 Fibrinolytic Therapy Received Within 30 Minutes YES YES Ongoing Abstract AMI / SCPC OP-3 Median Time to Transfer to Another Facility for Acute Coronary Intervention YES YES Ongoing Abstract AMI / SCPC OP-4 Aspirin at Arrival YES YES Ongoing Abstract

OP-5 Median Time to ECG YES YES Ongoing Abstract AMI / CP/ SCPC OP-6 Timing of Antibiotic Prophylaxis NO YES Ongoing Abstract

OP-7 Prophylactic Antibiotic Selection for Surgical Patients NO YES Ongoing Abstract

OP-8 MRI Lumbar Spine for Low Back Pain YES NA Ongoing Medicare Claims

OP-9 Mammography Follow-up Rates YES NA Ongoing Medicare Claims

OP-10 Abdomen CT - Use of Contrast Material YES NA Ongoing Medicare Claims

OP-11 Thorax CT - Use of Contrast Material YES NA Ongoing Medicare Claims

OP-12 The Ability for Providers with HIT to Receive Laboratory Data Electronically Directly into their Qualified/Certified EHR System as Discrete Searchable Data NO NA 1/1/2011 Structural (YES/NO) LAB

OP-13 Cardiac Imaging for Preoperative Risk Assessment for Non Cardiac Low-Risk Surgery YES NA 1/1/2011 Medicare Claims

OP-14 Simultaneous Use of Brain Computed Tomography (CT) and Sinus CT YES NA 1/1/2011 Medicare Claims

OP-15 Use of Brain Computed Tomography (CT) in the ED for Atraumatic Headache NA 1/1/2011 Medicare Claims Postponed 07/12

OP-16 Troponin Results for ED AMI or chest pain patients (with Probable Cardiac Chest Pain) Received Within 60 minutes of Arrival NA 1/1/2012 Abstract AMI / CP/ SCPC

& LAB OP-17 Tracking Clinical Results between Visits NA 1/1/2012 Structural (YES/NO) LAB OP-18 Median Time from ED Arrival to ED Departure for Discharged ED Patients 2013 NA 1/1/2012 Abstract

OP-19 Transition Record with Specified Elements Received by Discharged Patients

NA

1/1/2012

Abstract -YES or NO

SUSPENDED FROM VALIDATION / APU

04/12 OP-20 Door to Diagnostic Evaluation by a Qualified Medical Professional NA 1/1/2012 Abstract

OP-21 ED- Median Time to Pain Management for Long Bone Fracture NA 1/1/2012 Abstract

OP-22 ED- Patient Left Before Being Seen NA 1/1/2012 Abstract

OP-23 ED- Head CT Scan Results for Acute Ischemic Stroke or Hemorrhagic Stroke who Received Head CT Scan Interpretation Within 45 minutes of Arrival NA 1/1/2012 Abstract

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Hospital Outpatient Quality Data Reporting Program Summary from Outpatient Prospective Payment System (OPPS)

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Measure # CY2012, CY2013, CY2014 Payment Determination Effective Collection MEASURE SET

OP-1 Median Time to Fibrinolysis Ongoing Abstract AMI / SCPC

OP-2 Fibrinolytic Therapy Received Within 30 Minutes Ongoing Abstract AMI / SCPC

OP-3 Median Time to Transfer for Acute Coronary Intervention Ongoing Abstract AMI / SCPC

OP-5 Median Time to ECG Ongoing Abstract AMI/ CP/ SCPC

OP-12 The Ability for Providers with HIT to Receive Laboratory Data Electronically Directly into their Qualified/Certified

EHR System as Discrete Searchable Data 1/1/2011 Structural

(YES/NO) LAB

OP-16 Troponin Results for ED AMI or chest pain patients Received within 60 minutes of Arrival (aka: Door to Result)

1/1/2012 Abstract AMI/ CP/ SCPC & LAB

OP-17 Tracking Clinical Results between Visits 1/1/2012 Structural (YES/NO) LAB

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UPDATE: CMS OP-16 MEASURE CHANGE

On August 13, 2012, CMS issued an SDPS Memorandum #12-257-OD for the removal of Hospital Outpatient Quality Reporting (HOQR) measure OP-16.

“The Centers for Medicare & Medicaid Services (CMS) announces the immediate removal of the following measure from the HOQR measure set: OP-16…

We are removing OP-16 from the HOQR measure set based on patient safety concerns. On July11, 2012 the Food and Drug Administration (FDA) issued a Class I recall on several point of care (POC) testing kits, including those that provide Troponin results. The Class I recall was due to false results… (see FDA website – ucm311405)

While OP-16 does not specify which type of laboratory equipment should be used to obtain Troponin results, hospitals may be using these POC tests in order to expedite results. In view of the recent Class I recall, CMS is concerned that continued collection of the measure may potentially impact patient safety because of the high probability of false results associated with such equipment.”

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UPDATE: CMS OP-16 MEASURE CHANGE

“ CMS WILL NOT publically report, validate or use in CY 2013 payment determination any data collected on this measure…

…CMS is unable to immediately cease data collection in the system. In order to overcome CMS’s system limitation, hospitals can choose to submit a value that is not meaningful for this measure.

Please do not submit a blank value for OP-16, as a lack of a populated value for OP-16 will cause a case to be rejected. If a case is rejected due to lack of data, this could impact a hospital’s ability to meet Hospital OQR requirements for receiving a full outpatient hospital annual payment update…Hospitals are encouraged to work with their vendors to determine options to populate the OP-16 data field at submission.” CMS SDPD MEMORANDUM #12-257-OD

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Hospital Outpatient Quality Data Reporting Program Summary from Outpatient Prospective Payment System (OPPS) –

Updates

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Measure # Measure Short Name: MEASURE SET:

OP-15 Use of Brain Computed Tomography (CT) in the ED for Atraumatic Headache

Public Reporting Postponed until

2013 (07/12)

OP-16 Troponin Results for ED AMI or chest pain patients (with Probable Cardiac Chest Pain) Received Within 60 minutes of Arrival

SUSPENDED FROM VALIDATION / APU

08/12

OP-19 Transition Record with Specified Elements Received by Discharged Patients

SUSPENDED FROM VALIDATION / APU

04/12

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Measure # Measure Short Name: CY2012, CY2013, CY2014 Payment Determination

OP-12 The Ability for Providers with HIT to Receive Laboratory Data Electronically Directly into their Qualified/Certified EHR System as Discrete Searchable Data

OP-17 Tracking Clinical Results between Visits

OP 12 and OP 17

= YES or NO answer only

Departments Included: ED, outpatient imaging, outpatient surgery, clinics

The "Yes" or "No" is not linked to APU, just whether it was answered

*EHR must be Office of the National Coordinator for Health Information Technology (ONC) certified

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OPPS SUMMARY

Validation and Payment Requirements

All hospitals submit data to CMS; all measures must be addressed

Payment: ~2% percent 4 measures (OP 12, 16, 17 and 19) are currently not included in the determination for the APU

75% compliance requirement for reimbursement Failure to meet 75% = to failing to report = ~ 2% reduction in

annual payment update (APU)

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Why OP-16 was implemented originally?

CMS statement of Troponin TAT as a measure of “quality”

“…The focus of this measure is on the timeliness of the receipt of the Troponin results…For this reason, we believe timeliness of the availability of the test results is a marker of quality because it results in more timely treatment decisions and treatment delivery, which in turn results in better outcomes for patients.” CMS-1525-FC

Suspension of this measure does not negate the real impact of why it was originally implemented. Facilities should continue to strive towards assessment and reductions in the diagnostic TAT (door –to-result).

Any progress and momentum in goal setting, improved communications and reductions of time will continue to impact patient care and quality outcomes.

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Process Improvement Methods

Nurse driven or pre-approved standing order protocols

Validation tools CAP QM1 Monitor – meets SCPC requirements Goals need to be established from the various phases “door-to-result”

Lab workflow assessments and optimization: Door to Result Pre-analytical and analytical Lab and hospital information systems Connectivity Education for both the ED and Lab on detailed time-tracking processes

Key Players: Lab / ED / Cardiology ED Director / ED Medical Director / CPC Medical Director CPC Coordinator / Quality Department

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Summary

Best demonstrated practices have requirements for defining and tracking cumulative turn-around-

time metrics of the whole-process or the patient-centric view.

As such, timeliness of the reporting of Troponin

equals timeliness of the diagnosis for the appropriate delivery of care in the Acute Coronary Syndrome patient population.

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Links and Resources

Society of Chest Pain Centers www.scpcp.org or [email protected]

College of American Pathologists www.cap.org

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Links and Resources

CMS and OPPS http://www.cms.gov/HospitalOutpatientPPS/

www.qualitynet.org http://www.hospitaloqr.com

http://www.hospitalcompare.hhs.gov

CMS is accepting public comments through September 4, 2012 for the proposed rules for 2013-2015 payment determinations. These can be found on the CMS website under “ CMS-1589-P” to download instructions of the Federal Register/ Vol. 77, No. 146/ Monday, July 30, 2012/ Proposed Rules/ PDF page 7 & 116-128, Hospital OQR Program.

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Thank You!

[email protected] 36