In the News:  Center for Medicare and Medicaid Services Activities

The Center for Medicare and Medicaid Services [CMS] has been reviewing its coverage parameters for home prothrombin assays.  This review included a research study that looked at existing evidence supporting the benefits of this testing.  Currently coverage is restricted to mechanical heart valve patients, but the recommendations coming out of this study propose that Medicare coverage of home prothrombin time (INR) monitoring be expanded to include both chronic atrial fibrillation and deep venous thrombosis when certain conditions are met.  Conditions listed in these proposed recommendations include that the Medicare beneficiary:

• requires chronic oral anticoagulation with warfarin for a mechanical heart valve, chronic atrial fibrillation or deep venous thrombosis; and
• has had at least three months of anticoagulation therapy prior to use of the home INR device;
• has participated in an educational program on anticoagulation management;
• can demonstrate the correct use of the device prior to its use in the home;
• continues to correctly use the device for the management of the anticoagulation therapy;
• self-tests with the device no more than one time a week.

Included with this recommendation is the identification of six tests that have been cleared by the Federal Food and Drug Administration [FDA] for prescriptive home use for prothrombin assays.  These are

Source: CMS 2007

Another important aspect of quality care and patient safety for patients on warfarin sodium therapy is education. This study also includes recommendations relative to warnings that should be provided to patients on warfarin.  These are focused on the bleeding risks associated with this medication, which are more likely to happen during the initiation of therapy or when a higher dosage of warfarin sodium is administered.  Identified risk factors include:

• high intensity of anticoagulation (INR >4.0),
• age > 65,
• highly variable INRs,
• history of gastrointestinal bleeding, hypertension,
• cerebrovascular disease,
• serious heart disease,
• anemia,
• malignancy,
• trauma,
• renal insufficiency,
• concomitant drugs [Note: review all drug and food precautions closely], and
• long duration of warfarin therapy.

In addition to instructing patients and families about the risks of bleeding, patients and families should also be taught techniques to prevent and/or minimize bleeding.  Instructions on what signs and symptoms to immediately report to the physician should also be in the patient’s teaching plan.

The National Coverage Determination draft memo is available online for consumers and providers to read in its entirety.  In addition to the draft memo, there is detailed information on the research conducted with outcomes and findings in more detail.  Requests for comments on the draft memo are currently underway.  Additional details and information is available at: https://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?from2=viewdraftdecisionmemo.asp&id=209