Medicare's New Regulations for Deep Vein Thrombosis as a “Never Event”: Wise or Worrisome?

Clearly Define What Changed Beginning October 1, 2008 

The legislation attempts to improve patient safety by decreasing the frequency of hospital-acquired complications and, in turn, reducing Medicare's and Medicaid's expenses. If a “never event” condition is absent upon hospital admission, but subsequently occurs during the hospitalization, Medicare will not pay the incremental cost to manage the complication. Furthermore, the patient is not responsible for the additional cost. Rather, the hospital bears the additional financial burden.

The Debate about “Never Events” Related to Deep Vein Thrombosis and Pulmonary Embolism after Total Knee or Hip Replacement 

A challenge for providers will be to decide when to declare venous thromboembolism as “present on admission” or “present on admission cannot be determined,” because many venous thromboembolism cases are asymptomatic.7, 8 The designation of “present on admission cannot be determined” implies the need for further testing, including imaging studies such as venous ultrasonography and chest computed tomography. This approach, if routinely applied, will increase health care costs.

The use of prophylaxis in total knee and hip arthroplasty reduces the risk of postoperative deep vein thrombosis or pulmonary embolism.9 Freedman et al9 analyzed 52 trials with 10,929 participants in their meta-analysis showing that, when compared with placebo (49%), the risks of total deep vein thrombosis were reduced effectively with low-molecular-weight heparin (18%), pneumatic compression (21%), and warfarin (23%). The recommended prophylactic regimens according to the American College of Chest Physicians for total knee or hip replacement include: low molecular weight heparin, fondaparinux, or warfarin with a target international normalized ratio of 2.5, ranging from 2.0 to 3.0.10 Thromboprophylaxis after total hip arthroplasty is recommended for at least 10, and up to 35, days.10

However, the American Association of Orthopedic Surgeons has published guidelines that differ from the American College of Chest Physicians by permitting the use of aspirin in lieu of low-molecular-weight heparin, fondaparinux, or warfarin.11 Aspirin can be started on the day of surgery and continued for 6 weeks.11 This recommendation has sparked controversy, and the American College of Chest Physicians argues that there is no role for aspirin because it was less effective than low-molecular-weight heparin, fondaparinux, or warfarin.

Eikelboom and colleagues12 argue that the American Association of Orthopedic Surgeons recommendations are based more upon expert opinion than rigorous scientific evidence.12 If aspirin prophylaxis is not effective, then this strategy will expose medical centers to increased financial liability under the new Medicare policy.

Favorable Aspects of the “Never Event” Designation 

Classification of postoperative venous thromboembolism in the setting of total knee or hip replacement as a “never event” emphasizes the importance of prophylaxis. Venous thromboembolism prophylaxis is cost effective, yet not universally used among orthopedic patients.13 Medicare's new policy should serve to unify health care practices. Hospitals now have extra incentive to maximize the intensity of preventive efforts in orthopedic surgery patients.

Unfavorable Aspects of the “Never Event” Designation 

Although prophylaxis is cost effective, the net effect of the “never event” designation to patient care remains unclear because: the new regulation may discourage aggressive diagnosis of venous thromboembolism once the patient is admitted,14 and prophylaxis does not eliminate the risk completely. Any system that incorporates a punitive component risks limiting full disclosure and encouraging the release of incomplete data about patient safety.14 Clinicians and institutions might curtail diagnostic procedures that are associated with these disincentives.15

Conclusions 

Improving patient safety should improve quality, boost performance, and lower costs. Under governmental pressure, a congressional mandate, and public demand for quality, the Centers for Medicare and Medicaid Services added a punitive element, denying reimbursement for “never events.” Because venous thromboembolism, even with universal prophylaxis, is not always preventable, hospital systems may incur added cost. However, hospitals may realize net savings if this new “never event” policy results in a marked reduction in hospital-acquired pulmonary embolism and deep vein thrombosis. The effect of this policy on hospitals and their patient safety systems will soon become apparent.