The American Journal of Medicine
Volume 122, Issue 11 , Pages 975-976, November 2009

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

  • Juwono L. Sutedjo, MD

      Affiliations

    • University of Massachusetts Medical Center, Worcester
    • ,
  • Roger K. Ng, MD

      Affiliations

    • University of Massachusetts Medical Center, Worcester
    • ,
  • Gregory Piazza, MD

      Affiliations

    • Brigham and Women's Hospital, Harvard Medical School, Boston, Mass
    • ,
  • Samuel Z. Goldhaber, MD

      Affiliations

    • Brigham and Women's Hospital, Harvard Medical School, Boston, Mass
    • Corresponding Author InformationRequests for reprints should be addressed to Samuel Z. Goldhaber, MD, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, 75 Francis St., Boston, MA 02115

Article Outline

 

The Surgeon General's Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism estimates that more than 100,000 deaths occur annually from pulmonary embolism in the US alone.1 Many of these deaths are preventable by prescribing proved prophylactic measures during hospitalization. In addition, venous thromboembolism and its complications place a substantial burden on the US health care system.2 The sequelae of deep vein thrombosis and pulmonary embolism—post-thrombotic syndrome3 and chronic thromboembolic pulmonary hypertension4, 5—respectively, are sources of morbidity, diminished quality of life, and loss in functional status.

Patient safety has taken center stage in the discussion of our nation's health care system. Medicare's most recent strategy to reduce medical errors is to withhold payment to hospitals for treatment of serious preventable illnesses or complications termed “never events.” The President's Fiscal Year 2009 Budget outlined this approach.6 This legislation prohibits hospitals from billing for these events. The legislation also requires that hospitals report occurrence of these “never events.”6 The initial 3 in-hospital “never events” were: foreign object retained after surgery, air embolism, and blood transfusion incompatibility. The subsequent 5 “never events” were: severe pressure ulcers, falls and trauma, catheter-associated urinary tract infections, vascular catheter-associated infections, and mediastinitis after coronary artery bypass grafting. As of October 1, 2008, 3 additional “never events” were specified: surgical site infections following certain elective procedures, certain manifestations of poor blood sugar control, and deep vein thrombosis and pulmonary embolism occurring after total knee or hip replacement. This commentary will explore the merits and implications of classifying venous thromboembolism after total knee or hip replacement as a “never event.” The policy adopted by Medicare is controversial because postoperative venous thromboembolism following total knee or hip arthroplasty is not always preventable.

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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.

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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.

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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.

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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

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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.

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References 

  1. Office of the Surgeon General. The Surgeon General's Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism. http://www.surgeongeneral.gov/topics/deepvein/Accessed December 8, 2008
  2. MacDougall DA, Feliu AL, Boccuzzi SJ, Lin J. Economic burden of deep-vein thrombosis, pulmonary embolism, and post-thrombotic syndrome. Am J Health Syst Pharm. 2006;63:S5–S15
  3. Kahn SR, Shrier I, Julian JA, et al. Determinants and time course of the postthrombotic syndrome after acute deep venous thrombosis. Ann Intern Med. 2008;149:698–707
  4. Condliffe R, Kiely DG, Gibbs JR, et al. Prognostic and aetiological factors in chronic thromboembolic pulmonary hypertension. Eur Respir J. 2009;33:332–337
  5. Lang IM, Klepetko W. Chronic thromboembolic pulmonary hypertension: an updated review. Curr Opin Cardiol. 2008;23:555–559
  6. Centers for Medicare and Medicaid Services, HHS. Medicare program: changes to the hospital inpatient prospective payment systems and fiscal year 2009 rates; payments for graduate medical education in certain emergency situations; changes to disclosure of physician ownership in hospitals and physician self-referral rules; updates to the long-term care prospective payment system; updates to certain IPPS-excluded hospitals; and collection of information regarding financial relationships between hospitals (Final rules). Fed Regist. 2008;73:48433–49084
  7. Kim YH, Oh SH, Kim JS. Incidence and natural history of deep-vein thrombosis after total hip arthroplasty (A prospective and randomised clinical study). J Bone Joint Surg Br. 2003;85:661–665
  8. Adams RC, Hamrick M, Berenguer C, et al. Four years of an aggressive prophylaxis and screening protocol for venous thromboembolism in a large trauma population. J Trauma. 2008;65:300–306
  9. Freedman KB, Brookenthal KR, Fitzgerald RH, et al. A meta-analysis of thromboembolic prophylaxis following elective total hip arthroplasty. J Bone Joint Surg Am. 2000;82A:929–938
  10. Geerts WH, Bergqvist D, Pineo GF, et al. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. (8th Edition) Chest. 2008;133:381S–453S
  11. American Academy of Orthopaedic Surgeons Physician Work Group. American Academy of Orthopaedic Surgeons Clinical Guideline on Prevention of Symptomatic Pulmonary Embolism in Patients Undergoing Total Hip or Knee Arthroplasty (American Academy of Orthopaedic Surgeons). http://www.aaos.org/research/guidelines/PE_guideline.pdfAccessed February 21, 2009
  12. Eikelboom JW, Karthikeyan G, Fagel N, Hirsh J. American Association of Orthopedic Surgeons and American College of Chest Physicians guidelines for venous thromboembolism prevention in hip and knee arthroplasty differ: what are the implications for clinicians and patients?. Chest. 2009;135:513–520
  13. Cardiovascular Disease Educational and Research Trust, Cyprus Cardiovascular Disease Educational and Research Trust, European Venous Forum, International Surgical Thrombosis Forum, International Union of Angiology, Union Internationale de Phlebologie. Prevention and treatment of venous thromboembolism (International Consensus Statement (guidelines according to scientific evidence)). Int Angiol. 2006;25:101–161
  14. Pronovost PJ, Goeschel CA, Wachter RM. The wisdom and justice of not paying for “preventable complications”. JAMA. 2008;299:2197–2199
  15. Streiff MB, Haut ER. The CMS ruling on venous thromboembolism after total knee or hip arthroplasty: weighing risks and benefits. JAMA. 2009;301:1063–1065

 Funding: Dr. Goldhaber was supported, in part, by an unrestricted grant from Sanofi-Aventis. Drs. Sutedjo, Ng, and Piazza report no outside support for their work on this project.

 Conflict of Interest: None.

 Authorship: All authors had access to the data and participated in writing this manuscript.

PII: S0002-9343(09)00575-0

doi:10.1016/j.amjmed.2009.04.019

The American Journal of Medicine
Volume 122, Issue 11 , Pages 975-976, November 2009

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