Use of Outcome Measurements: Warfarin, NOACs and How They Apply to MU and National Quality Measures

Part 2 in a 5 part series - Improving the Quality of Chronic Oral Anticoagulation with Evidence-Based Guidelines

The Center for Medicare and Medicaid Services (CMS) has identified Time in Therapeutic Range (TTR) as a Meaningful Use goal, and highlights that TTR’s greater than 70% represent high quality warfarin care, TTR’s of 65-70% are considered acceptable warfarin care and TTR’s under 65% needs improvement.

The National Quality Foundation has endorsed multiple quality measures for anticoagulation, which include both inpatient and outpatient measures. The outpatient measures include monthly testing of INR values, more frequent testing of INR values of individuals taking interacting medications such as antibiotics, and implementation of measures to ensure that regular and frequent INR testing is done on patients using Coumadin.

Table 4.Alex Blog 2

Meaningful use stage 3 is the third phase of the meaningful use EHR incentive program which also highlights important anticoagulation measures for EHR’s. Key metrics are important from a process point of view.  Some of these requirements include the use of clinical decision support rules for eligible patients to include INR re-testing evaluation and INR testing while taking anti-infection medication such as antibiotics. INR re-testing evaluation involves the use of clinical reminders to assess the need for INR testing for those requiring frequent testing intervals (< 30 days) or if it has been more than 180 days since the last INR. As well as clinical notification for INR testing when drugs known to interfere with warfarin such as anti-infective medications are initiated. Meaningful use measures for EHR’s become an important part of the overall quality metrics for warfarin that have been endorsed by federal quality organizations.

Table 5.Alex blog 2

In addition to warfarin, which was the only oral anticoagulant that we have had for over half a century, we’ve seen tremendous progress in the last 7 years or so with the non-vitamin K antagonist oral anticoagulants (NOAC’s). NOAC’s are, tailor-made agents that interfere with specific steps within the coagulation cascade, whether by inhibiting propagation of coagulation through activated factor Xa or thrombin activity itself by inhibition of factor II. A plethora of agents (including apixiban, rivaroxaban, betrixaban,, edodoxaban and dabigatran) have revolutionized chronic oral anticoagulant care because they have very predictable pharmacokinetic and pharmacodynamic profiles, and have decreased drug/drug and drug/food interactions compared to Coumadin.

But these agents have come with their own paradigms with respect to measuring their anticoagulant effects and adherence, as well as their interaction with other potential medications such as anti-platelets and other meds. Instead of the need to routinely monitor INRs with these agents, we shift to another standard of monitoring.

These agents include processes such as:

  • Consistent and regular patient education, especially with respect to adherence of these new medications
  • Monitoring the potential for interaction with other co-medications (although much more limited than Coumadin) such as Azoles and HIV inhibitor agents, as well as select antibiotics and cardiac medications.
  • And importantly, regular blood work, especially with respect to renal function with these medications.

Table 3. Alex blog 2

We see that although the criterion for NOACs is much simpler than Coumadin, there are metrics associated with both adherence, compliance and use of the NOACs that have a profound impact on how practitioners treat AC patients on a routine basis.

What have we learned in the last 20 years or so in how we achieve optimal oral anticoagulant control, specifically for warfarin. We know that the advent of point of care INR testing is very important along with the use of patient self-testing and self-management of INRs. We know it’s important to have a dedicated trained healthcare team with respect to AC management. For example, Northwell uses a FDA approved point of care device in our clinics, like many other clinics throughout the U.S., to assist in obtaining a direct INR value at the point of care in a face to face visit versus the traditional approach of waiting for INR values to come out of laboratories and can take anywhere from 24-48 hours to get results.

What we have seen in the last 2 years or so, are CMS driven MACRA/MIPS payments which are merit based incentive payment system. CMS has now given a high rating for anticoagulant management improvement as well as participation in a systematic anticoagulation program. This involves the use of an anticoagulant management program that coordinates systematic care, comprehensive patient education, and systematic INR testing, tracking, dosing and follow-up. CMS also includes incentives for implementing a validated electronic decision support system along with clinical management tools to deliver that care at the point of patient contact. Payments and MIPS metrics apply not just to warfarin but to other coagulation cascade inhibitors such as direct oral anticoagulants.

We are entering a new era in oral anticoagulation therapy. We now have a wide range of treatment options available to the AC patient, as well as new opportunities in how that AC care is coordinated and delivered. Is your clinic ready for the new CMS MACRA incentives? Has your clinic considered integrating a validated electronic decision support system to facilitate these new incentives without disrupting the care you deliver? Let’s take this a step further. Does your decision support system accelerate efficiency and safety and leave you and your patient highly satisfied? Tell me about your experience in the comments below.

Topics: Anticoagulation, Meaningful Use, Warfarin, DOAC, Adverse Drug Events, NOAC, National Quality Measures, TTR