Implementation of Anticoagulation Patient SelfTesting in an Indian Health Service Facility

1
Implementation of Anticoagulation Patient
Self-Testing in an Indian Health Service Facility

• LT John Bousum, Pharm.D.
• Pharmacy Resident
• Claremore Indian Hospital

2
Objectives

• List the requirements for patient self-testing
  (PST) by the Centers for Medicare and Medicaid
  Services (CMS)
• Explain the potential role of PST in the
  management of anticoagulation therapy

3
2008 CHEST Guidelines

• 4.3.1. In patients who are suitably selected and
  trained, PST is an effective alternative
  treatment model. We suggest that such therapeutic
  management be implemented where suitable. (Grade
  2B)

Ansell J, Hirsh J, Hylek E, et al. Pharmacology
and Management of the Vitamin K Antagonists.
CHEST 2008 133(6)160-98S.
4
Warfarin Black Box Warning

• Regular monitoring of INR should be performed on
  all treated patients
• Those at high risk of bleeding may benefit from
  more frequent INR monitoring

Warfarin. Facts Comparisons 4.0. Wolters Kluwer
Health, Inc. Accessed Mar. 9, 2009.
5
CMS Requirements

• Chronic oral anticoagulation with warfarin
• Mechanical heart valve (exluding porcine)
• Chronic atrial fibrillation
• Venous thromboembolism (DVT and PE)
• 3 months of anticoagulation prior to PST
• Face-to-face training
• Correct use of the point-of-care device
• Test no more than once a week

Ph. Durrough S, Jacques L, Spencer F, et al.
Decision Memo for Prothrombin Time (INR) Monitor
for Home Anticoagulation Management.CMS 2008.
File CAG 00087R
6
CMS Billing Codes
International Normalized Ratio
7
CLIA-Waived POC Devices
CoaguChek XS (Roche Diagnostics)
INRatio (HemoSense Inc.)
ProTime (ITC)
8
PST Reimbursement
aIncludes 13 sets of 4 results (52 weeks)
Burgwinkle P, et al. Oral anticoagulation patient
self-testing concensus guidelines for practical
implementation. Managed Care Supp.
200817(10)1-8.
9
Annual Reimbursement
10
Criteria for Patient Selection

• Willing to participate
• Able to
• use POC device
• report results
• attend visits
• Reliable in following instructions
• Accessible via telephone

Burgwinkle P, et al. Oral anticoagulation patient
self-testing concensus guidelines for practical
implementation. Managed Care Supp.
200817(10)1-8.
11
Barriers to PST
Wittkowsky AK, et al. Barrers to patient
self-testing of prothrombn time national survey
of anticoagulation practitioners.
Pharmacotherapy. 200525(2)265-9.
12
Reasons for PST

• Improved time in therapeutic range (TTR)
• Improved patient understanding of warfarin
  therapy
• Ease of burden for providers
• Convenience for patients
• Improved quality of care

13
Research Support

• Systematic review and meta-analysis
• 14 randomized trials of PST
• Results reductions in

Heneghan C, et al. Self-monitoring of oral
anticoagulation a systematic review and
meta-analysis. Lancet 2006 367404-11
14
Implementation of PST Program

• Objective feasibility of PST in an IHS facility
• Methods
• Prospective observational analysis
• Face-to-face training by pharmacist
• Assessment of TTR
• 3 months before and after training
• Determined by linear interpolation
• Patient satisfaction survey using Likert scale

15
Baseline Demographics
Mean SD
16
Aortic Valve Results
TTR
17
Mitral Valve Results
TTR
18
Combined Results
TTR
19
Problems

• Forgetting to test
• Forgetting to report INR
• Improper technique
• Time constraints for patient contact

20
Next Step

• Reevaluate policy and procedures
• Expand service to include more patients
• Further defining eligibility criteria
• Investigate options for billing

21
Patient Self-Testing

• LT John Bousum, Pharm.D.
• Pharmacy Resident
• Claremore Indian Hospital
• john.bousum_at_ihs.gov