Prevention and management of thrombosis using low-molecular-weight hepari
The American Society of Consultant Pharmacists held its 33rd Annual Meeting and Exhibition, “Senior Care Pharmacy ’02,” in Anaheim, CA, on November 13-16, 2002. At a satellite symposium entitled, “Prevention and Management of Thrombosis Using Low-Molecular-Weight Heparins: The Challenge of Optimizing Clinical and Economic Outcomes in the Skilled Nursing Facility,” two speakers described strategies and tools that pharmacists can use to manage the cost of using low-molecular-weight heparins, thereby improving both clinical outcomes for nursing home residents and economic outcomes for skilled nursing facilities.
Strategies for Reimbursement of Low-Molecular-Weight Heparin in the Skilled Nursing Facility
Garry Woessner, MA, MBA, CAS, is Business Development Specialist for Intrepid USA Healthcare Services, a national network of home health care and other senior health care services. He is also a surveyor for the Commission on Accreditation of Rehabilitation Facilities (CARF) and is certified as a Subacute Administrator through the American College of Health Care Administrators. Mr. Woessner discussed methods of reimbursement used by major payor groups within different sites of care, focusing on long-term care settings such as skilled nursing facilities (SNFs), and on the features of low-molecular-weight heparins (LMWHs) that affect Medicare reimbursement to SNFs.
Mr. Woessner began by explaining that reimbursement for pharmaceutical products depends on both the payor and the site of care. Medicare is a major driver of reimbursement for patients 65 years and older. Medicare Part A covers both inpatient hospital services and short-term care in an SNF. Medicare Part B covers practitioner services, use of outpatient facilities, and durable medical equipment. Part B is an optional supplementary insurance available to individuals who are eligible for Part A, and coverage is funded partly by monthly premiums paid by subscribers. SNF residents who no longer meet the criteria for Part A may still have coverage under Part B, because in many states, the Medicaid program pays Part B premiums for Medicaid recipients. By doing this, Medicaid programs shift to Medicare costs that would otherwise be covered by Medicaid.
Under Medicare Part A, the requirements for coverage of care for SNF patients include admission to an SNF within 30 days after a hospital stay of at least 3 days (not including the day of discharge), and physician certification that reasonable and medically necessary care is required on a daily basis and can be provided only in an SNF. If the patient continues to qualify—that is, skilled care continues to be medically necessary and appropriate—Medicare Part A covers up to 100 days of SNF care. The first 20 days are covered at 100%, and the next 80 days are covered at 80%. The average length of stay for patients covered by Medicare Part A is about 20 days.
Within the hospital setting, drug reimbursement is typically bundled into an all-inclusive, fixed amount that is dictated by the patient’s discharge diagnosis. Similar diagnoses are clustered into diagnosis-related groups (DRGs). DRG 209, for example, includes patients who have hip or knee replacement surgery. Because hospital reimbursement is made through a prospective payment system (PPS) that is based on an adjusted average payment rate, the amount of a Medicare payment can be either higher or lower than actual costs. Prior to the Balanced Budget Act of 1997, a hospital that transferred a patient to an SNF received full DRG payment regardless of when the transfer occurred. However, the Centers for Medicare & Medicaid Services (CMS) were concerned that this postacute care transfer policy would create financial incentives for hospitals to transfer patients prematurely. Therefore, in 1998, CMS implemented a new policy under which the hospital’s reimbursement for certain DRGs is prorated when a patient is transferred directly to an SNF before reaching the average length of stay. The new policy applies to 10 DRGs, including DRG 209 and others, in which LMWH is typically used.
Medicare reimbursement has changed for SNFs as well. In contrast to hospitals, which receive fixed-payment reimbursements, SNFs previously received cost-based reimbursements. However, in 1998, Medicare implemented PPS reimbursement for SNFs, and payment is now based on resource utilization groups (RUGs), into which drug reimbursement is bundled. For SNF residents who are Medicaid recipients, drug costs are either billed separately under the state’s fee schedule, or are bundled into state-specific Medicaid PPS reimbursements.
Mr. Woessner noted that the average operating cost, all payors considered, is $109 per resident per day. Medicaid reimbursement averages only about $110 per day, and reimbursement by private payors also has a very low profit potential. Although Medicare accounts for the smallest percentage of the typical payor mix for SNFs—only 7% compared with 65% for Medicaid and 28% for private payors—Mr. Woessner pointed out that the Medicare program is “the only place that SNFs have a real potential to take some dollars to the bottom line.” This potential exists for two reasons. First, the profit margin is potentially greater for Medicare patients, who, because of the acuity of their conditions, have an estimated average cost per day of about $200, and an estimated average Medicare reimbursement per day of $320 to $350. Second, for Medicare patients, the pharmacy bills the SNF, and the SNF bills Medicare under the bundled RUG level. This reimbursement flow is in contrast to that for Medicaid and private-pay patients, for whom the pharmacy bills the payor directly. By bundling its billing to Medicare directly and effectively managing its pharmacy cost, the SNF can retain any profit that results from keeping costs lower than reimbursements.
Of the $200 cost per day for Medicare-covered patients, $125 is typically spent on room and board, while $75 is spent on ancillary services. The typical breakdown for ancillary services is approximately $50 (67%) for rehabilitation, $19 (25%) for drugs, and $2 (3%) each for laboratory tests, supplies, and other services. The typical breakdown for Medicare utilization by census days is 76% rehabilitation; 21% extensive services (including IVs), clinically complex, and special care; and 3% reduced physical functioning, impaired cognition, and behavior disorders.
In the SNF setting, each patient is assessed by use of the Minimum Data Set (MDS) tool. The patient’s MDS score determines the RUG category, and each RUG has a corresponding Medicare reimbursement. The MDS must be scored at defined intervals during a patient’s stay in the SNF. For a patient who is eligible for 100 days of Medicare coverage and remains in the SNF throughout that period, the MDS must be scored at days 5, 14, 30, 60, and 90. If the MDS score changes, the RUG—and the reimbursement—may change. Of the more than 500 items on the MDS tool, only a few affect a patient’s RUG classification and Medicare reimbursement, including rehabilitation therapy, activities of daily living (ADLs) score, certain diagnoses and conditions, depression or mood problems, behavior problems, cognitive impairment, and certain special treatments such as intravenous (IV) drug administration. For example, reimbursement is higher for a patient who receives rehabilitation therapy, because the cost of providing such therapy is higher.
Mr. Woessner described how drug selection affects SNF revenues and expenses. Drugs that improve alertness and tolerance for rehabilitation therapy increase revenue by allowing patients to participate in more therapy sessions and to be categorized into higher reimbursement RUGs. Similarly, drugs that require IV administration place patients into higher reimbursement RUGs. However, costs are increased by use of drugs that have a higher risk of adverse effects or medication errors, which prevent patients from participating fully in rehabilitation therapy, or which require additional staff time to administer or monitor.
Focusing on LMWHs, Mr. Woessner discussed three major reimbursement advantages. First, LMWHs are safer than unfractionated heparin (UH). LMWHs are associated with fewer skin tears and less bleeding, and therefore, lower secondary costs. Second, the use of LMWHs has the potential to increase revenue by increasing the amount of time a patient can spend in rehabilitation therapy, and by decreasing census days lost to rehospitalization. Third, the use of LMWHs can decrease costs by reducing laboratory expenses as well as staff time for drug administration and monitoring. Many other advantages of LMWHs are detailed in Table I.
To implement practice changes in the SNF, consultant pharmacists should be prepared not only to present the economic advantages of LMWH, but also to address any concerns about the use of LMWH. For example, although LMWH is more expensive than UH, the ability of patients to participate in rehabilitation therapy and to be categorized into higher reimbursement RUGs can help offset that difference. Some patients for whom treatment with LMWH is appropriate are short-stay patients. In such cases, the SNF makes a front-end investment in the form of higher drug costs, but may not achieve the back-end benefit provided by reimbursement for longer-term rehabilitation therapy. To optimize both clinical and economic outcomes with LMWH, Mr. Woessner recommended utilization management strategies, including managing the quantity of drug ordered so that the SNF orders and pays for only the doses required.
Efficacy, Safety, and Value of Low-Molecular-Weight Heparin as a Component of Thromboembolic Management
Nancy Losben, RPh, CCP, FASCP, is Senior Vice-President of Clinical Services for NeighborCare, a long-term care pharmacy services provider serving more than 260,000 long-term care residents. She holds an adjunct faculty appointment at Temple University School of Pharmacy and at the University of the Sciences in Philadelphia, PA. Ms. Losben discussed the clinical advantages of LMWH for prevention of deep-vein thrombosis (DVT) or for treatment of DVT with or without pulmonary embolism (PE). She described a point-of-service program to manage the cost and utilization of LMWH, and identified steps that the consultant pharmacist can take to improve the SNF census and monitor anticoagulant therapy.
Ms. Losben began her presentation by saying that her customers have learned that “they can admit high-acuity, short-stay orthopedic residents that pay very well. One of the reasons that they are able to comfortably and safely admit those types of residents is because of the availability, safety, and ease of use of LMWH in reducing the risk of DVT—or even treating DVT with or without PE—in these very high-risk populations.”
The key to successful implementation of LMWH in SNFs is managing utilization. At Ms. Losben’s company, this is accomplished by bringing together a point-of-service team driven by dispensing pharmacists, and also including physicians and consultant pharmacists. Through this program, dispensing pharmacists can make sure that they are dispensing only the supply of LMWH that is actually needed. Doing so decreases the overall cost of LMWH by ensuring appropriate utilization, reducing inventories, and reducing costs relating to unused doses.
As an example, Ms. Losben described a group of 52 high-acuity SNFs that recently budgeted a 20% increase in Medicare Part A days, but wanted to keep costs down. By achieving appropriate utilization through a point-of-service program, the group discovered a 19% reduction in costs for LMWH. “You can institute a program like this with your own customers,” Ms. Losben said. “The first thing you need to do is learn to justify the use of a higher-cost medication. For many reasons, LMWH is much better than UH.”
Treatment of DVT with UH requires an IV and is generally administered in the acute care setting. In contrast, LMWH is administered subcutaneously once or twice daily, and can easily be used in the SNF or home setting. Unlike UH, LMWH typically does not require monitoring with laboratory tests. Because of its long half-life and high bioavailability, LMWH provides a more predictable anticoagulant response that seldom requires adjustment. In addition, LMWH is associated with fewer recurrences of thromboembolism, fewer major bleeding episodes, and fewer deaths. In a study of patients with acute DVT, enoxaparin use reduced the average length of hospitalization from 5.4 days to 0.97 days.1 When these advantages are taken into account, LMWH is a less expensive treatment than UH, even though the medication cost is higher.2
Ms. Losben suggested that consultant pharmacists cite the Efficacy and Safety of Subcutaneous Enoxaparin in Non–Q-Wave Coronary Events (ESSENCE) study3 when discussing with their clients the clinical and economic advantages of LMWH. The ESSENCE study provided data confirming the safety, efficacy, and economic benefits of enoxaparin in the treatment of unstable angina or non–Q-wave myocardial infarction.3,4 Major findings of the study include a 5% reduction in coronary angioplasty, a lower rate of rehospitalization, and cost reductions that persisted over a 30-day observation period (Table II).
Ms. Losben described changing practices in SNFs. In the past, when a patient developed DVT, the SNF would discharge the patient to the hospital for 5-10 days of treatment with UH. Today, because of the safety and efficacy of LMWH, that patient can be evaluated in the emergency room, the location and extent of the DVT can be assessed, and treatment with LMWH can be started. The patient can then return immediately to the SNF for continued treatment, reducing the hospital stay to less than 1 day on average. Of the available LMWHs, only enoxaparin is FDA-approved for use in the outpatient treatment of acute DVT. Another reason that LMWH can be used comfortably in the SNF setting is that LMWH has fewer drug interactions than UH. As would be expected, both LMWH and UH have interactive effects with platelet inhibitors, oral anticoagulants, and thrombolytic agents. However, UH has additional drug interactions—with cephalosporins, nitroglycerine, penicillin, and angiotensin-converting enzyme inhibitors—that make its use more problematic. Thrombocytopenia is another important risk factor in the use of UH. The incidence of thrombocytopenia in patients treated with UH is 3%, and the risk of thrombosis or death associated with thrombocytopenia is greater than 50%.
Ms. Losben suggested that consultant pharmacists articulate to their customers the prevalence of DVT in their patient populations. Risk factors for DVT are extremely common in SNF patients. These risk factors include increasing age; history of thrombosis; immobilization; pelvic, abdominal, or joint replacement surgery; medical conditions such as myocardial infarction, congestive heart failure, stroke, and chronic obstructive pulmonary disease; central venous lines; obesity; infection; and clotting disorders. The level of risk for DVT can be determined according to the number of risk factors present, with one risk factor associated with a low level of risk, and five or more risk factors associated with a very high level of risk. Nursing home patients typically have a high or very high level of risk. “These are the people who should be using LMWH to prevent DVT,” said Ms. Losben, “especially because of the risk of DVT associated with the types of surgery commonly performed in this patient population.”
To achieve cost control with LMWH, Ms. Losben suggested that consultant pharmacists take the following steps: review clinical appropriateness; define and monitor utilization, based on diagnosis and expected duration of therapy; introduce and support a point-of-service program driven by the dispensing pharmacist; and educate and monitor the SNF staff. Ms. Losben described this type of program as “the epitome of pharmaceutical teamwork, when both the consultant pharmacist and the dispensing pharmacist work with the physicians and nurses.”
Pharmacists must be aware that because the various LMWHs differ in their derivation or synthesis, molecular size, and anticoagulant activity, they are not substitutable. The hospital will have a specific LMWH on formulary, and the SNF must be prepared to continue therapy with the same drug. The appropriate dosing and duration of therapy must also be ensured, based on indication, patient age and weight, level of risk, acute care start date, stop order date, and whether the care plan calls for initiation of warfarin therapy.
The dose and duration of postacute therapy with enoxaparin are based on the indication. For hip or knee replacement, the recommendation is 30 mg every 12 hours for at least 7 days and until the risk of DVT diminishes (1-3 weeks total). An alternative regimen for hip replacement patients substitutes a once-daily 40-mg dose in place of a twice-daily 30-mg dose. For prevention of DVT in abdominal surgery, the recommendation is 40 mg enoxaparin once daily for 7-10 days, or longer if risk factors persist. Ms. Losben said that patients with acute medical illness and restricted mobility are the most underassessed population in the SNF setting. The recommendation for enoxaparin in this group is 40 mg once daily for 6-11 days.
The main principle of the point-of-service program for LMWH is that appropriate utilization hinges on dispensing the correct quantity of the drug to complete the regimen as indicated. To accomplish this, the team must identify the indication to determine the appropriate dose, frequency, and duration of therapy; determine the date that therapy was initiated in hospitalized patients who were transferred to the SNF; and dispense only enough doses to cover the remaining days of therapy. Ms. Losben suggested that the point-of-service program consider adopting policies to help manage utilization. For example, reordered prescriptions should be questioned, inquiries should be made regarding warfarin if an order is not received with admission orders, and a written “stop” order should be completed for every patient. These items and others, such as nondrug adjunct therapy and patient age, diagnosis, and risk factors, can be included in a pharmacist intervention and assessment form.
In addition to the pharmacist intervention and assessment form, other tools for a point-of-service program include pharmacist educational materials, physician educational materials, and determination of acute care product selection in the hospitals that transfer patients to the SNF. For consultant pharmacists who are seeking resources to help them in the establishment of a point-of-service program for LMWH, Ms. Losben recommended “The Expanding Role of Low-Molecular-Weight Heparins,” a special report published by the American Pharmaceutical Association.5
This special report was produced by MultiMedia HealthCare/Freedom, LLC, under an unrestricted educational grant from Aventis Pharmaceuticals. The views expressed in this publication are not necessarily those of Aventis Pharmaceuticals, or the publishers. This publication may not be reproduced in whole or in part without the express written permission of MultiMedia HealthCare/Freedom, LLC.
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