Download CMS Shared Decision

NCDR Registry Requirements and
EMR Capabilities
Wendy Schell, MSN, RN, AGACNP-BC, APN, CCRN
Amy Schwartz, BSN, RN
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Agenda
• Registry Requirements Supporting NCD
• Shared Decision Making
• Registry
–
–
–
–
Getting Started
Resources
Data collection
Data submission
• EMR Build
• Q&A
Background Information
• CMS released the national coverage determination (NCD) for LAA
– Effective date of coverage is February 8, 2016
• All Medicare Administrative Contractors have updated their Category III
code policies to include coverage of 0281T under the LAAC NCD
• CMS forwarded program instructions to the local contractors to update
their claims processing systems to be in compliance with the NCD
– Implementation date: October 3, 2016
– MLN article on LAAC defines billing instructions for hospitals and
physicians
• Registry certification occurred August 17,2016
LAAO Registry
•
•
•
•
•
The LAAO Registry is designed to assess the prevalence, demographics, management, and
outcomes of patients undergoing percutaneous and epicardial based left atrial appendage
occlusion procedures to reduce the risk of stroke.
The primary goals of the registry are to optimize outcomes and management of patients
through the implementation of evidence-based guideline recommendations in clinical
practice, facilitate efforts to improve the quality and safety for these patients, investigate
novel quality improvement methods, and provide risk-adjusted assessments of patients for
comparison with nationwide NCDR data.
The secondary purpose of the registry is to serve as source of clinical data to support
assessments of short and long term safety, comparative and cost effectiveness research and
as a scalable data infrastructure for post market studies.
Physicians and hospitals can use these data to support quality improvement efforts locally,
monitor patterns of care, and assess procedure utilization and variability.
Registry data will be used to help develop clinical guidelines leading to improved patient care
and ultimately will provide a better understanding of this population and emerging treatment
options.
CMS Registry Approval
https://www.cms.gov/Medicare/Coverage/Coverage-with-EvidenceDevelopment/LAAC.html
NCD for LAAO
•
Procedure must be performed in a hospital with an
established structural heart disease or EP program.
•
Procedure must be performed by an IC, EP, or Cardiovascular
Surgeon meeting the following criteria:
– Trained by the manufacturer
–
≥ 25 interventional cardiac procedures involving transseptal punctures
through an intact septum
– Continues to perform ≥25 interventional cardiac procedures involving
trans-septal punctures through an intact septum, with at least 12 being
LAAC over a two year period
• Must be enrolled in a prospective national
registry
LAAO Registry Inclusion Population
• Consecutive left atrial appendage occlusion procedures on
patients >= 18 years
• Devices implanted via a percutaneous/catheter-based
approach
• Device is non-investigational and FDA approved
• Inclusive of off label device use where device is being used
for another purpose other than the described indication
given to the device as part of FDA approval
• Open surgical approaches not included
• Sampling not permitted
• Patient entered location in which procedure is intended to
be performed
Patient Eligibility for LAAC Therapy
1
CHADS2 score >2 or
CHA2DS2VASc score >3
2
Suitability for
Short Term
Warfarin
3
Formal Shared
Decision Making
with a noninterventional
physician
Must be
documented in
medical record
to assess stroke
risk score and
eligibility
for LAAC.
NCD for LAAO
Eligible patients must have:
•
•
•
CHADS2 score ≥ 2 or CHA2DS2-VASc score ≥ 3.
Suitable for short-term warfarin
Deemed unable to take
long-term oral anticoagulation.
•
Documented
Evidence of a formal shared decision
interaction between the patient
and an independent, noninterventional physician using an
evidence-based decision tool on
oral anticoagulation in patients with NVAF prior to LAAC.
(LAAC is only covered as second line therapy to OAC)
Sign Up for CardioSmart on ACC Website
CMS Shared Decision
Shared decision making has the patient at the center and is much more structured, evidencebased and importantly interactive with bilateral exchange of information compared to
informed consent. Patients differ in their risk for ischemic stroke and risk of major bleeding,
making generic information inadequate.
The NICE patient decision aid does not mention LAAC. While CMS recognizes that no evidence
based shared decision making tool on LAAC has been published, we encourage the
development of such a tool given the complex considerations for anticoagulation in NVAF and
invasive interventions.
We have required the use of an evidence-based tool on anticoagulation in NVAF since
consideration of anticoagulation is inseparable from the decision on LAAC.
In the meantime, the shared decision making interaction will be augmented with the addition
of non-interventional providers that either have a relationship with the patient, such as the
primary care provider, or those with experience caring for stroke patients, to the patient’s care
team.
Documentation Criteria
Referring/Consult note should reflect:
– Outline the decision for LAAO based on past history
– List current and past medication use (antiplatelets ,NSAIDs, NOACs, Warfarin)
& contraindication to anticoagulation
– SDM Tool utilized
– CHA2DS2-VASc score and Yearly Risk of Stroke %
– (Encourage HAS-BLED)
Specialist Consults Involved:
– GI
– Neuro
– Hematologist
Supporting the Shared Decision
• Education Packets
• Tools available
– ACC
– NICE
– SPARC
Patient Welcome & Education
Shared Decision Making Tools:
ACC Shared Decision Tool
NICE Tool
Sparc Tool
https://www.cardiosmart.org/hea
lthwise/te81/26/te8126#te8129
WATCHMAN Template for MD dictation
Diagnosis of Non-valvular afib: The patient is being considered for Watchman LAA occlusion device. The
patient has need for anticoagulation and is considered a high risk for stroke, but has a relative
contraindication for long term anticoagulation. The patient is suitable for short-term warfarin but
deemed unable to take long term oral anticoagulation following the conclusion of the shared decision
making interaction utilizing the NICE tool. The patient watched the video for the Watchman device. We
discussed the procedure with risks, benefits and alternatives. They understand, questions were
answered. The patient understands that anticoagulation will be maintained in a variety of forms during
the first year and agrees. Risks include but not limited to: infection, bleeding, vessel injury, cardiac
perforation at times requiring drainage or surgery, heart failure, migration of the device, emergency
surgery, myocardial infarction, stroke and death.
1)
CHA2DS2-VASc score is ___
2)
Yearly risk of stroke is ___%
3)
HAS-BLED score is ___
4)
Estimated Rate of Major Bleeding with 1-Year of OAC is 4.9-19.6%
5)
Contraindication to oral anticoagulation is ____________________.
CHA2DS2VASc Score 5 (CHF,HTN,Age,DM) HASBLED Score 4
Assessment/Plan: 78 year old gentleman with PMH chronic diastolic heart failure with mild systolic failure, chronic persistent afib on
warfarin who presents with hematochezia and shortness of breath now evaluated for potential Watchman therapy.
Mr. X. has a history of non valvular AF. He is at increased risk for stroke and systemic embolism based on a CHA2DS2-VASc1 Score of 5 and
is recommended for anticoagulation therapy.
He is being evaluated for a Watchman Device as an alternative to warfarin and Mr. X has been found to be suitable for short term Warfarin
however is unable to take long term Warfarin for the following reasons: recurrent episodes of GI bleeding and gastritis found on recent
EGD with a HASBLED Score of 4
The patient’s current medical management regimen includes: ASA and Warfarin
Side effects suffered from these medications include: Recurrent GI Bleeding requiring hospitalization and temporary discontinuation of
Warfarin. He was deemed to be not a candidate for ablation per electrophysiology
The rational for this procedure over pharmacologic therapy includes: Recurrent GI bleeding affecting Mr X's quality of life taking into
account the safety and effectiveness of the device compared to warfarin.
A formal shared decision was reached with Mr, X Through the use of the ACC Shared decision making tool (Scanned to media section of
Epic) and He has made the decision to have this device implanted with hopes of eliminating continued necessity for the long-term use of
warfarin.
I feel that Mr. X will benefit greatly from this procedure. His quality of life and well-being is greatly impacted by atrial fibrillation and other
health conditions including recurrent Diverticulosis , Gastritis, GI bleeding, dizziness with recent fall, and Chronic congestive heart failure.
- TEE for Assessment of LAA
Case and Plan discussed with Dr. Sabir
Wendy Schell APN-C
Cardiology – Structural Heart Team
University Cardiology Service
Cooper University Hospital
I, Sajjad A Sabir, MD, have seen and examined the patient on 3/24/2016. I agree with the resident's assessment and
plan as written, with exceptions as noted.
TEE images reviewed personally and 3D reconstruction performed. Complex left atrial appendage (LAA) with multiple
lobes. Two small lobes are just distal to the LAA os. Would have to deploy the device just above that to ensure no lobe
is left uncovered. There is a small chance of not being able to do that in which case the procedure would have to be
aborted. I discussed this and the rest of the details of the procedure including risks and benefits with patient in detail.
The risks include but are not limited to bleeding, groin hematoma, pseudoaneurysm, AV fistula, infection, pericardial
effusion, tamponade, arrhythmias, stroke, device embolization, emergency surgery, contrast induced nephropathy,
and death. Patient would also need to be "cleared" by GI to be able to take the coumadin for at least 6 weeks postimplant. At 6 weeks, we repeat a TEE. If no thrombus on the device or no significant leak around the device,
coumadin will be stopped and replaced by Plavix up until he is 6 months out from the procedure. Pt would like to
proceed "as soon as possible". He was hoping to have it done during this admission but the next available date is
Wednesday April 20. Will tentatively add pt on for that day.
Called Dr. Nussbaum's cell and left a message on her cell. Team can call me at my cell at 267-716-7757 if any
questions. Pt also has our Structural Heart direct cell phone number he can call us on if he has any additional
questions.
------------------------1
January CT, Wann LS, Alpert JS, et. al., 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial
Fibrillation A Report of the American College of Cardiology/American Heart Association Task Force on Practice
Guidelines and the Heart Rhythm Society, Circulation, 2014; 130: e199-e267.
LAAO Registry: Getting Started
• Go to NCDR website:
• http://cvquality.acc.org/NCDR-Home/Registries/HospitalRegistries.aspx
• Click on “Join a Registry” and fill out required information and
choose LAAO Registry™ under Hospital Registries.
• Fee: $15,000
• 1.Download LAAO Registry Packet
• 2.Complete enrollment materials
• 3.Mail completed materials along with payment to NCDR
• Contact: 800-257-4737 or [email protected]
National Audited Registry
• Consecutively enrolls LAAO patients
• Tracks the following annual outcomes for each patient for a
period of at least two years from the time of the LAAC:
•
•
•
•
•
•
Operator-specific complications
Device-specific complications including device thrombosis
Stroke/ TIA, adjudicated, by type
Systemic embolism
Death
Major bleeding, by site and severity
Education Home Page
Monthly Site Manager & User Calls
RSM and New User Call Schedule
Monthly Case Scenarios
Monthly Case Scenario Education
Support: FAQ Database
Are the Modified Rankin Scale and Barthel Index Evaluation
required to be administered for each follow-up?
• Participants should provide responses for all of the data elements,
including follow-up.
• Individual clinicians or facilities may have their own protocols based
on device selection and directions for use as to what is evaluated at
each follow-up
• All sequences in the follow-up require a response, if there is no
documentation of the Modified Rankin Scale and the Barthel Index
Evaluation performed…
• sequence #13081 Modified Rankin Scale “Not Administered”
• sequence #13085 “No”, Barthel Index Evaluation Performed
Data Dictionary
Coding Instructions
Target Values
Valid Ranges
A. DEMOGRAPHICS
Last Name
2030
SSN
2000
:
First Name
:
-
Birth Date
2050
:
Race:
(check all that apply)
□
-
Patient ID
SSN N/A
mm / dd / yyyy
Sex
2060
2076
:
O No
3000
:
O No
3010
:
:
□
Patient Zip Code2065:
O Female
Zip Code N/A
2066
If Yes, Ethnicity Type:
□ Puerto Rican2101
□
(check all that apply)
□ Other Hispanic, Latino or Spanish Origin2103
2102
Cuban
□ Private Health Insurance
□ Medicare
□
□ State-Specific Plan (non-Medicaid) □ Indian Health Service □
□
Medicaid
Military Health Care
Non-US Insurance
:
Research Study3020: O No
If Yes, Study Name3025, Patient ID3030:
O Yes
Admitted for LAA Occlusion Intervention
C. HISTORY
TO
AND
RISK FACTORS (PRIOR
CHA2DS2-VASC
TO
3045
If Yes, NYHA Functional Classification
CHA2DS2-VASc Hypertension
4015
4020
CHA2DS2-VASc Stroke
4035
CHA2DS2-VASc TIA
TO
4030
:
4025
:
:
RISK SCORES
4055
4060
HAS-BLED Abnormal Renal Function
HAS-BLED Abnormal Liver Function
4070
:
□
,
Patient Restriction
3035
O Yes
O Yes
O Class I
O Class II
O Yes
O Class III
O Class IV
CHA2DS2-VASc Thromboembolic Event
4045
O No
O Yes
CHA2DS2-VASc Vascular Disease
O No
O Yes
If Yes, Vascular Disease Type
O No
O Yes
O No
O Yes
O No
O Yes
HAS-BLED Bleeding
O No
O Yes
HAS-BLED Labile INR
O No
O Yes
HAS-BLED Alcohol
O No
O Yes
□ Prior MI
4050
□ PAD
□
4040
:
:
:
O No
O No
O Yes
O Yes
(Select all that apply)
Known Aortic Plaque
1
HAS-BLED Hypertension (Uncontrolled)
HAS-BLED Stroke
O No
:
O No
:
HAS-BLED
:
4010
:
CHA2DS2-VASc Diabetes Mellitus
O No
1
4005
CHA2DS2-VASc LV Dysfunction
:
FIRST PROCEDURE)
RISK SCORES
CHA2DS2-VASc Congestive Heart Failure
SPECIFIC
Other ID
O Yes
:
(Select all that apply)
SPECIFIC
(auto)
2020
mm / dd / yyyy
If Yes, Payment Source
3015
:
2045
(ADMISSION)
OF CARE
Health Insurance3005:
HIC #
Middle Name
O Male
O Yes
□ Mexican, Mexican-American, Chicano2100
Arrival Date
:
:
□ White2070
□ Black/African American2071
□ American Indian/Alaskan Native2073
□ Asian2072 If Yes, □ Asian Indian2080 □ Chinese2081 □ Filipino2082 □ Japanese2083 □ Korean2084 □ Vietnamese2085 □ Other2086
□ Native Hawaiian/Pacific Islander2074 If Yes, □ Native Hawaiian2090 □ Guamanian or Chamorro2091 □ Samoan2092 □ Other Island2093
Hispanic or Latino Ethnicity
B. EPISODE
2010
2040
2031
4065
:
:
:
If
4095
:
4100
4105
:
:
HAS-BLED Drugs - Antiplatelet
4110
:
O No
O Yes
O No
O Yes
O No
O Yes
O No
O Yes
4115
HAS-BLED Drugs - NSAIDS
http://cvquality.acc.org/en/NCDR-Home/DataCollection/What-Each-Registry-Collects.aspx
Data Quality Report
• All data must be submitted through the DQR
• •Data not received in NCDR data warehouse unless green or yellow
submission status obtained
• •Data > Data Collection Tool > Maintenance
DQR Benchmark Inclusion Status
Falling Data Assessment
• Data NOT received in data warehouse
• Remains only on the hospital platform in DCT
• Will not be in the Outcomes Report
Falling Completeness Assessment
•
•
•
•
Data received in the data warehouse
NOT included in metrics, rolling 4 quarters,
or national aggregates
Displayed in detail section quarterly statistics
Passing the DQR
•
•
•
Data received in the data warehouse
included in metrics, rolling 4 quarters,
and national aggregates
DQR SAMPLE
Follow Up Data
• Base submissions must be complete and
pass data submission prior to submitting
follow up data
• Create only 1 follow up for each of the 4
time frames
• Submit all follow ups regardless of when
they occur
Follow Up Details (No metrics yet established for follow-ups)
•
Each procedure requires follow up at these intervals: (these have changed)
• 45 day (+/- 14 days)
• 6 month (+60 days/- 30 days)
• 1 year (+/- 60 days)
• 2 year (+/- 60 days)
•
Methods to determine follow up status may vary:
• Office Visit
• Medical Records
• Letter from Medical Provider
• Phone Call
• Social Security Death Master File
• Hospitalized (this has to be >24 hours or overnight otherwise check office visit)
In-Hospital Metrics
L. FOLLOW-UP
Follow-up should be performed at the following intervals post-procedure:
45 days (+/- 14 days), 6 months (+ 60 days/- 30 days), 1 year (+/- 60 days), 2 years (+/- 60 days)
Assessment Date
13000
: mm / dd / yyyy
Procedure Start Date/Time
7001/7002
Method(s) to Determine Status:
Follow-up Status13015: O Alive
If Deceased, Cause of Death
O Acute myocardial infarction
O Sudden cardiac death
O Heart failure
O Stroke
O Cardiovascular procedure
O Cardiovascular hemorrhage
O Other cardiovascular reason
□ Office Visit13005
□ Medical Records13006
□ Letter from Medical
Provider13007
13008
13009
13010
□ Phone13011
Call
□ Social Security Death Master File
□ Hospitalized
□ Other
O Deceased
13020
If Deceased, Date of Death
: mm / dd / yyyy HH:MM
O Lost to Follow-up
: mm / dd / yyyy
13025
:
O Pulmonary
O Renal
O Gastrointestinal
O Hepatobiliary
O Pancreatic
O Infection
O Inflammatory/Immunologic
O Hemorrhage
O Non-cardiovascular procedure or surgery
O Trauma
O Suicide
O Neurological
O Malignancy
O Other non-cardiovascular reason
Adjudication
Adjudication of adverse events occurring in hospital as well as follow up period:
A.
Neurologic
1.
2.
3.
4.
5.
B.
Hemorrhagic Stroke
Ischemic Stroke
Undetermined Stroke
TIA
Intracranial Hemorrhage
Bleeding
1.
2.
3.
4.
5.
Access Site Bleeding
Hematoma
Vascular Complications
GI Bleeding
Retroperitoneal Bleeding
Future adjudication - Systemic Thromboembolism
EMR Build
EMR Build
EMR Build
CQI = Improved Patient Care
Questions?