The Centers for Medicare and Medicaid Services (CMMS), formerly the Health Care Financing Administration (HCFA), recently announced that Medicare will now cover home tests for prothrombin time in certain circumstances. Prothrombin time, also know as PT or Pro Time, measures the time it takes your blood to form clots and is important in monitoring patients taking blood-thinning medications (anticoagulants), such as warfarin. PT results are reported after adjusting them to the International Normalized Ratio (INR); therefore, the tests are often referred to as home INR monitors.

Although there are several FDA-approved home PT tests on the market, until now, patients have had to pay for them out-of-pocket. With this new national coverage decision, patients with mechanical heart valves who are covered by Medicare will be able to be reimbursed for the cost of weekly use of their home PT monitoring devices. Selection of the Medicare patient population for coverage was based on evidence that all patients with mechanical heart valves are on anticoagulant therapy and that most patients needing anticoagulation are older and, therefore, covered by Medicare.

The implications of this coverage decision are significant. There are between 600,000 and 900,000 patients with heart valves, many of whom are Medicare beneficiaries and will be taking anticoagulant medication for the rest of their lives. The Medicare policy also will likely impact private insurance companies, many of which already do cover home PT tests; those that do not may be persuaded to adopt a coverage policy, which will make these home tests more affordable for many patients.

It is estimated that implementation of this coverage policy will be completed within the next six months to one year.

Sources

Medicare Coverage Policy Decision Memorandum

Auxter, S. Why labs should monitor the home PT (INR) Medicare coverage debate. Clinical Laboratory Strategies June 2001 6(6): 2, 7.