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Medicare Reform Needed for Home-Based Low-Molecular-Weight Heparin Therapy

      To the Editor: Similar to its policy regarding parenteral antibiotics, Medicare currently reimburses for the administration of low-molecular-weight heparin (LMWH) in office, clinic, and emergency department settings but does not pay for homebased treatment. Individual Medicare patients must provide out-of-pocket payment for home-based LMWH treatment or choose to remain in the hospital or go to a nursing home to complete intravenous heparin therapy. Paradoxically, if Medicare patients who are homebound and receiving home health care nursing receive outpatient (office- or clinic-based) LMWH therapy, they become ineligible for home nursing benefits.
      More than a dozen randomized clinical trials have compared outpatient (including at-home) LMWH therapy to unfractionated heparin for initial management of venous thromboembolism and found LMWH to be safe and at least as effective as unfractionated heparin in reducing the incidence of recurrent, symptomatic deep venous thrombosis, pulmonary embolism, and death.
      • Schraibman IG
      • Milne AA
      • Royle EM
      Home versus in-patient treatment for deep vein thrombosis.
      • Segal JB
      • Bolger DT
      • Jenckes MW
      • et al.
      Outpatient therapy with low molecular weight heparin for the treatment of venous thromboembolism: a review of efficacy, safety, and costs.
      The potential magnitude of cost savings with use of outpatient-based LMWH therapy is substantial. Segal et al
      • Segal JB
      • Bolger DT
      • Jenckes MW
      • et al.
      Outpatient therapy with low molecular weight heparin for the treatment of venous thromboembolism: a review of efficacy, safety, and costs.
      systematically reviewed 19 studies involving outpatient LMWH therapy that addressed the issue of costs via direct comparison or decision analysis and reported a median cost savings of 57% with LMWH vs unfractionated heparin use. In a cost-minimization analysis, van Den Belt et al
      • van Den Belt AG
      • Prins MH
      • Lensing AW
      • et al.
      Fixed dose low molecular weight heparin versus adjusted dose unfractionated heparin for venous thromboembolism.
      determined that substitution of in-hospital heparinization with at-home LMWH therapy would result in a 64% reduction in costs. According to decision-analysis modeling, treatment with LMWH resulted in cost savings when as few as 8% of patients were treated at home.
      • Gould MK
      • Dembitzer AD
      • Sanders GD
      • Garber AM
      Low-molecular-weight heparins compared with unfractionated heparin for treatment of acute deep venous thrombosis: a cost-effectiveness analysis.
      Two studies, 1 from Canada
      • O'Brien B
      • Levine M
      • Willan A
      • et al.
      Economic evaluation of outpatient treatment with low-molecular-weight heparin for proximal vein thrombosis.
      and 1 from the United States,
      • Tillman DJ
      • Charland SL
      • Witt DM
      Effectiveness and economic impact associated with a program for outpatient management of acute deep vein thrombosis in a group model health maintenance organization.
      comparing outpatient enoxaparin with in-hospital unfractionated heparin for treatment of deep venous thrombosis reported cost savings per treatment course of $2422 (57%) and $3025 (60%), respectively. The average cost reduction in these 2 studies was $2724, and with an overall mean age- and sex-adjusted annual incidence of deep venous thrombosis in the United States of 48 per 100,000 population (160,640 new cases per year),
      • Silverstein MD
      • Heit JA
      • Mohr DN
      • Petterson TM
      • O'Fallon WM
      • Melton III, LJ
      Trends in the incidence of deep vein thrombosis and pulmonary embolism: a 25-year population-based study.
      the national financial impact of a strategy using outpatient LMWH therapy can be as much as $435 million annually.
      In the mid-1980s, reimbursement for home intravenous antibiotic therapy by third-party payers paradoxically lagged behind accumulated literature evidence that confirmed its safety, efficacy, and cost-saving benefits.
      • Smego Jr, RA
      Home intravenous antibiotic therapy [editorial].
      Within the private insurance industry, logic eventually caught up with logistics, and home parenteral antibiotic treatment became the cornerstone of management for a variety of infectious disease syndromes that has reduced treatment costs while ensuring clinical outcomes that equal those provided by in-hospital antimicrobial therapy. Today, Medicare still does not reimburse for home intravenous antibiotics, or LMWH, but does provide coverage for home-based care, with strict guidelines, for the following parenteral medications: antirejection agents (eg, cyclosporine, tacrolimus), cancer chemotherapeutic agents (eg, cyclophosphamide, etoposide), narcotic analgesics (eg, morphine sulfate, fentanyl), deferoxamine, insulin, inotropic agents (eg, dopamine, dobutamine), agents for pulmonary hypertension (eg, epoprostenol, treprostinil), antiviral agents (eg, acyclovir, ganciclovir), and antifungal agents (eg, amphotericin B deoxycholate, amphotericin B liposomal complex). Medicare reform is needed to address the inconsistency of home treatment reimbursements.

      REFERENCES

        • Schraibman IG
        • Milne AA
        • Royle EM
        Home versus in-patient treatment for deep vein thrombosis.
        Cochrane Database Syst Rev. 2001; 2: CD003076
        • Segal JB
        • Bolger DT
        • Jenckes MW
        • et al.
        Outpatient therapy with low molecular weight heparin for the treatment of venous thromboembolism: a review of efficacy, safety, and costs.
        Am J Med. 2003; 115: 298-308
        • van Den Belt AG
        • Prins MH
        • Lensing AW
        • et al.
        Fixed dose low molecular weight heparin versus adjusted dose unfractionated heparin for venous thromboembolism.
        Cochrane Database Syst Rev. 2000; 2: CD001100
        • Gould MK
        • Dembitzer AD
        • Sanders GD
        • Garber AM
        Low-molecular-weight heparins compared with unfractionated heparin for treatment of acute deep venous thrombosis: a cost-effectiveness analysis.
        Ann Intern Med. 1999; 130: 789-799
        • O'Brien B
        • Levine M
        • Willan A
        • et al.
        Economic evaluation of outpatient treatment with low-molecular-weight heparin for proximal vein thrombosis.
        Arch Intern Med. 1999; 159: 2298-2304
        • Tillman DJ
        • Charland SL
        • Witt DM
        Effectiveness and economic impact associated with a program for outpatient management of acute deep vein thrombosis in a group model health maintenance organization.
        Arch Intern Med. 2000; 160: 2926-2932
        • Silverstein MD
        • Heit JA
        • Mohr DN
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        Trends in the incidence of deep vein thrombosis and pulmonary embolism: a 25-year population-based study.
        Arch Intern Med. 1998; 158: 585-593
        • Smego Jr, RA
        Home intravenous antibiotic therapy [editorial].
        Arch Intern Med. 1985; 145: 1001-1002

      Linked Article

      • Celiac Disease Serology and Irritable Bowel Syndrome: Does the Relationship Merit Further Evaluation?: In Response
        Mayo Clinic ProceedingsVol. 79Issue 9
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          We appreciate Sanders and Azmy's comments and their interest in our article.1 We wish to clarify that our study design was different than inferred by Sanders and Azmy. The patients in our study were identified by the symptoms they reported on a survey mailed to a random sample of the community. Hence, ours was a population-based sample, not a sample of primary care patients. The study consisted of minimal-risk interventions, and thus the patients did not undergo small bowel biopsy as part of the study protocol.
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