Reimbursement for outpatient therapy with enoxaparin

Reimbursement for outpatient therapy with enoxaparin

REIMBURSEMENT CEU by Anu Dhamecha, PharmD, and Jessica Yaron, RN, MS V enous thromboembolic disease (VTED) comprises deep venous thrombosis (DVT) ...

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REIMBURSEMENT

CEU

by Anu Dhamecha, PharmD, and Jessica Yaron, RN, MS

V

enous thromboembolic disease (VTED) comprises deep venous thrombosis (DVT) and its potential-

ly fatal complication, pulmonary embolism (PE). The annual U.S. incidence of VTED has been estimated at 2 million.1 Clinical and autopsy data suggest that approximately 350,000 cases of PE, including 100,000 fatalities, occur annually in this country.2 TCM 56

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The mainstay of clinical management of VTED is anticoagulation, traditionally with unfractionated heparin (UFH) and, in recent years, low molecular weight heparin (LMWH). LMWH is gradually displacing UFH as the agent of choice for the prophylaxis and treatment of DVT and PE. Clinical advantages of LMWH over intravenous UFH include greater bioavailability, more predictable dose response, longer half-life, and a lower risk of bleeding.3,4 LMWH therapy is also associated with a low rate of VTED recurrence. In a study of patients who have DVT, 61% were considered eligible for outpatient therapy with LMWH, and the VTED recurrence rate in this group was only 1.9%, compared with a 4.1% recurrence rate in a matched group of patients who had been treated on an inpatient basis with intravenous UFH the previous year.5

The major cost-saving factor with LMWH is reduced hospitalization. Establishing stable anticoagulation with intravenous UFH requires several days in the hospital, whereas enoxaparin can be initiated in the hospital (or, in some cases, in the emergency department) and continued on an outpatient basis. In a study6 at a nonprofit teaching hospital, 125 patients received DVT treatment with enoxaparin for an average of 5.23 days, of which 4.26 days were on an outpatient basis. Thus, the average length of hospitalization was only 0.97 days, compared with a 5.4-day average stay with intravenous UFH treatment at the same hospital. Of these 125 patients, 122 (97.6%) required no rehospitalization for any reason. At the end of a 90-day follow up, the total cost savings compared with inpatient treatment with UFH was almost $309,000—more than $2470 per patient. The advantages of LMWH for outpatient prevention and treatment of VTED are now well recognized.7 Nevertheless, obtaining insurance coverage for enoxaparin may be difficult. The drug acquisition cost is substantially higher for LMWH than for UFH, and third-party payors may be unfamiliar with this treatment mode and its cost-effectiveness. In looking at overall costs rather than just drug-acquisition costs, the choice for insurers is between paying for several days in the hospital to establish stable anticoagulation with intravenous UFH or paying for a day or less in the hospital (or even a few hours in the emergency department) to initiate LMWH,

FIGURE 1. PRIVATE INSURANCE: ALGORITHM 1

FIGURE 2. MEDICAID (VARIES BY STATE): ALGORITHM 2

which can be continued on an outpatient basis. In either case, oral therapy with warfarin is introduced when stable anticoagulation with the injected agent has been achieved; once therapeutic levels are achieved with the oral agent, the injected agent is withdrawn, and warfarin monotherapy continues for approximately 3 to 6 months. During that extended period of outpatient therapy with warfarin, the main costs

involve blood draws and laboratory monitoring of prothrombin time (reported in terms of the International Normalized Ratio [INR], which should be maintained within a range of 2.0 to 3.0). Insurers also should be aware that clinical risks and associated potential costs are greater with a longer hospital stay and intravenous therapy (required for UFH) than with a shorter stay and subSeptember/October 2002

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Approved for use in the United States since 1993, the LMWH enoxaparin sodium has an established record of safety and effectiveness in the prevention and treatment of VTED. Because enoxaparin can be administered subcutaneously, outpatient therapy is entirely feasible. Compared with inpatient UFH treatment, outpatient enoxaparin treatment reduces overall health costs and improves use of clinical resources without compromising the quality of care. Routine laboratory monitoring is unnecessary with enoxaparin, and the subcutaneous route avoids the expenses (of equipment and nursing time) and risks associated with intravenous UFH infusion.

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FIGURE 3. MEDICARE: ALGORITHM 3

address, Social Security number, phone number, and employer information); clinical condition (diagnosis, medical regimen, and estimated duration of therapy); and insurance (name and telephone number of agent to contact at company and the insured’s name and identification number). This sheet should be completed and updated before any attempt is made to contact insurance providers. The case manager also confirms that the patient or a close family member is competent and comfortable with giving injections; otherwise, a home care agency, outpatient clinic, or other service must be identified for outpatient therapy. The following algorithms are designed for patients with insurance through private companies, Medicaid, or Medicare and for patients without insurance. Representative case studies illustrate the process by which coverage might be obtained for patients with private insurance and Medicare.

FIGURE 4. NO INSURANCE: ALGORITHM 4

cutaneous therapy (as feasible with LMWH). At any stage in communications with insurers, it may be necessary to explain the clinical and economic rationale for enoxaparin rather than UFH in the initial treatment of DVT. To address the problem of securing insurance coverage, we have devised algorithms to guide case managers and TCM 58

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discharge planners in obtaining coverage or reimbursement for outpatient DVT therapy with enoxaparin. This approach has been successful in various teaching hospitals. The initial step in this algorithmic approach is the preparation of a fact sheet to summarize all pertinent information about the patient (name,

Private Insurance Algorithm 1 Contact with the insurance company should take place before hospital discharge to verify or arrange coverage for continuing therapy on an outpatient basis (Fig 1). If LMWH is covered under a prescription plan, the patient can obtain the product at a local pharmacy; if it is covered under a major medical plan, a vendor will deliver the drug to the patient. The case manager should find out from the insurer whether a certain pharmacy or vendor is preferred for providing the drug and what portion of the cost, if any, is the patient’s responsibility. If the drug is not specifically covered, it may be necessary to discuss the case with the insurer’s medical director, emphasizing that, because the patient’s medical condition is stable enough to permit discharge, outpatient DVT therapy with enoxaparin is not only clinically advantageous but also more cost-effective than inpatient therapy with UFH. Approval for coverage may be granted under the company’s prescription plan or major medical plan. However, if the request for coverage is denied, the case should be handled as a patient with no insurance; a discussion of the management of patients without insurance comes later in this article.

A patient with private insurance HP is a 56-year-old woman who presented with right lower leg swelling and pain. An ultrasound confirmed lower extremity DVT. She was started on therapy with enoxaparin and warfarin and was anxious to return home to her family. Her physician, deciding she was medically stable, discharged her on the enoxaparin outpatient protocol and wrote an order for a discharge planner to arrange for therapy, including instructions for self-administration. The planner recorded the following information on the face sheet: Name: HP Address: 123 Cherry Lane Anytown, USA 00000 Phone: 999-555-4321 SSN: 123-45-6789 Employer: Royal Retailers 120 Division St. Anytown, US 00000 Diagnosis: Deep vein thrombosis Treatment: Enoxaparin 80 mg subcutaneously q 12 h × 5-6 days; warfarin 5 mg once daily Insurance: XYZ Insurance Corp. Phone: 1-800-001-0101 Insured’s name: DP Insured’s ID: 234-56-7890 Relation to patient: spouse The customer service department of XYZ Insurance was contacted to obtain precertification for home care (to obtain blood samples for monitoring INR during warfarin therapy) and find out whether XYZ has a preferred home health agency. The discharge planner then called XYZ’s prescription plan number and provided the face sheet information to determine whether enoxaparin is covered under the patient’s husband’s plan. After learning that enoxaparin is not specifically covered, the discharge planner asked to speak directly to the medical director and explained why outpatient treatment with enoxaparin would be far less costly to the company than having the patient admitted to the hospital for intravenous treatment with UFH. The medical director agreed to allow coverage under XYZ’s prescription drug program. Drug Central was identified as XYZ’s preferred local pharmacy, and Drug Central verified that it had the prescribed medication in stock. By the time HP was discharged, all the arrangements and verifications were complete, and she was able to go directly to the designated pharmacy to obtain the medication.

A patient insured through Medicare Part A and Part B LG, a 71-year-old man, was admitted to the hospital with a diagnosis of left leg phlebitis. An ultrasound confirmed DVT in his left leg, and the patient was placed on a regimen of enoxaparin 100 mg subcutaneously every 12 hours and warfarin 5 mg daily. The next day, his physicians decided he was medically stable and could continue treatment on an outpatient basis. The case manager evaluated the patient and recorded the following information: Name: LG Address: 1234 Hillary Lane

Medicaid Algorithm 2 Each state has its own Medicaid program to cover the costs of treating medically needy residents. Therefore, the Medicaid algorithm provides only a very general approach to acquiring cov-

Big City, US 00000 Phone: 444-555-6666 SSN: 234-56-7890 Employer: Retired, no pension, living alone, on Social Security Diagnosis: Deep vein thrombosis Treatment: Enoxaparin 100 mg subcutaneously q 12 h × 5-6 days; warfarin 5 mg once daily Insurance: Medicare Part A and Part B Phone: 1-800-999-8888 Insured’s name: LG Insured’s ID: 234-56-7890 Relation to patient: self The case manager verified LG’s coverage through Medicare Part B and arranged for outpatient care through a home health agency (for initial instructions about self-administration and visits to draw blood for INR monitoring). However, Part B does not cover medications, and LG could not afford to pay for enoxaparin or the 20% of the home care cost not covered by Part B. Fortunately, he was deemed eligible for the hospital’s patient assistance program because he has a fixed income and qualified for Medicare coverage. Alternatively, he could seek assistance through the Caremark program to obtain the drug.

A patient insured through Medicare Part A only RD is a 67-year-old man admitted to the hospital with pain and soreness around his left knee after a recent injury. Venous ultrasonography revealed a thrombus in the left anterior tibial vein. The physician prescribed enoxaparin 100 mg subcutaneously every 12 hours and warfarin 5 mg once daily. The next day, the patient was deemed medically stable and eligible to continue treatment as an outpatient with the assistance of a home health nurse. A case manager summarized the case information: Name: RD Address: 346 Canary Street Fairville, US 00000 Phone: 000-987-6543 SSN: 345-67-8901 Employer: Retired, has minimum-wage job at a store Diagnosis: Deep vein thrombosis Treatment: Enoxaparin 100 mg subcutaneously q 12 h ¥ 6 days; warfarin 5 mg once daily Insurance: Medicare Part A Phone: 1-888-010-1010 Insured’s name: RD Insured’s ID: 345-67-8901 Relation to patient: self RD is covered under Medicare Part A, which covers neither home health care nor drugs. He earns minimum wage, has no supplemental insurance, and cannot afford to pay for his medications. The case manager contacts a social worker to help the patient get home health care and medications. RD’s financial situation qualifies him for the hospital’s assistance program. The social worker calls the hospital’s home health care service and arranges for home visits to draw blood for monitoring INR. The pharmacy delivers the medications to the patient’s room and teaches RD self-administration of enoxaparin before he is discharged.

erage for outpatient therapy with enoxaparin, although home care is a standard benefit under most Medicaid plans (Fig 2). First, confirm that the patient is eligible for Medicaid. If specific coverage is available for outpatient therapy with

enoxaparin, the patient simply takes the prescription and Medicaid card to a pharmacy where it has been verified that the drug is in stock; even with Medicaid coverage, the patient may be responsible for a small copayment. OthSeptember/October 2002

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CASE STUDIES OF REIMBURSEMENT STRATEGIES

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erwise, the Medicaid decision-maker will have to be contacted to determine if coverage should be provided under a managed care or risk-based program; thereafter, the case is handled in the same way as for patients with private insurance. Medicare Algorithm 3 Medicare comprises several different types of coverage. Part A covers inpatient costs only. Patients with coverage limited to Part A receive no benefits for outpatient medication or home care. Therefore, to obtain coverage or reimbursement for outpatient DVT therapy with LMWH, the approach is the same as for patients without insurance (Fig 3). However, it may be possible in certain cases for outpatient treatment to be provided at a designated clinic or physician’s office that can bill under J-code 1650 for the cost of the drug and its administration. Part B, held by some Medicare patients in addition to Part A coverage, covers 80% of the cost of skilled outpatient care (mainly for home visits to draw blood for monitoring INR during warfarin therapy) but does not cover outpatient medication. For patients with Part B, the outof-pocket expense of outpatient DVT treatment with LMWH includes the cost of the drug itself plus any uncovered portions of clinical care. For ambulatory patients who receive the anticoagulant at an outpatient clinic rather than at home, Part B may cover all or part of the cost of the drug and its administration. In all these scenarios, total outpatient costs will be far less than the cost of a full hospital admission. Again, for patients who cannot afford the medication, the situation is analogous to having no insurance; if a designated outpatient provider is available in such cases, billing under J-code 1650 may be the best option. Prescription drug rider policies also are available through Medicare. Medicare with supplement simply means the patient also has private supplemental insurance for home care or prescribed medication. If the supplement covers outpatient DVT therapy with LMWH, the approach is the same as for patients with private insurance; otherwise, the case should be handled in the same way as for patients with no insurance. TCM 60

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HMO or risk-based Medicare is equivalent to private insurance, and the approach to securing coverage for outpatient DVT therapy with LMWH is the same as for patients with private insurance. Medicare with Veterans Administration (VA) benefits provides coverage through VA facilities. Patients who are eligible for VA benefits can obtain LMWH through the VA hospital pharmacy. Home care to assist in drug administration may be arranged separately. No Insurance Algorithm 4 Patients without medical insurance may have to rely on their own financial resources to obtain outpatient LMWH therapy but only after all other possible options have been explored (Fig 4). Some assistance programs can be accessed by the Internet (eg, www.rxassist.org, www. volunteersinhealthcare.com, www.needymed. com). Social Services also can help the patient apply for Medicaid or evaluate his or her eligibility for Social Security disability benefits or COBRA programs. Beyond such established avenues of medical-cost assistance, charitable agencies may provide help through a designated clinic or pharmacy. Aventis Pharmaceuticals has an assistance program called Caremark to help patients with no insurance, inadequate insurance, or insurance that does not pay for medications. The hospital’s social services department can obtain the appropriate forms by calling (888) 632-8607; the completed forms then are returned by fax to (888) 875-9951. If assistance is provided through Aventis, the patient can obtain enoxaparin at a designated pharmacy. Conclusion Outpatient therapy for VTED with the LMWH enoxaparin is both clinically advantageous and more cost-effective than inpatient treatment with UFH. However, insurers may not always provide coverage or reimbursement for this type of therapy. For patients who can be discharged on outpatient therapy, case managers and discharge planners should follow an algorithmic approach to securing coverage and should be prepared to present data supporting the clinical and financial benefits of outpatient treatment

with enoxaparin to insurers who are not familiar with this therapy. ❑ References 1. Hirsh J, Hoak J. Management of deep vein thrombosis and pulmonary embolism. A statement of health care professionals. Council on Thrombosis in consultation with the Council on Cardiovascular Radiology. Circulation 1996;93:2212-45. 2. Fareed J, Hoppensteadt DA, Bick RL. An update on heparins at the beginning of the new millennium. Semin Thromb Hemost 2000;26:5-21. 3. Merli G. Why are we talking about LMWHs? P&T Supplement 2001:2-4. 4. Rydberg EJ, Westfall JM, Nicholas RA. Low molecular weight heparin in preventing and treating DVM. Am Fam Phys 1999;59:1607-12. 5. Spyropoulos AC. Outpatient-based treatment protocols in the management of venous thromboembolic disease. Am J Manag Care 2000;6:S103444. 6. Groce JB III. Patient outcomes and cost analysis associated with an outpatient deep venous thrombosis treatment program. Pharmacotherapy 1998;18:175S-80S. 7. Agnelli G, Becattini C. Clinical and economic aspects of managing venous thromboembolism in the outpatient setting. Semin Hematol 2001;38:58-66. Anu Dhamecha, PharmD, and Jessica Yaron, RN, MS, work in the department of pharmacy at St. Vincent’s Hospital in Indianapolis, Ind. Acknowledgment: The authors will receive an honorarium from Aventis Pharmaceuticals for their involvement with this project and serve on Aventis’ speakers bureau. Reprint orders: Mosby, Inc., 11830 Westline Industrial Dr., St. Louis, MO 63146-3318; phone (314) 453-4350; reprint no. 68/1/127984 doi:10.1067/mcm.2002.127984

CEU: REIMBURSEMENT

CEU APPLICATION This article has been approved for 1 hour of CCM, CRC, and CDMS education credit by The Foundation for Rehabilitation Education and Research. To obtain your education credit, please do the following: 1. Read the “Reimbursement for Outpatient Therapy with Enoxaparin” article. 2. Make copies of this page for each person applying for credit. 3. Answer the following questions by selecting one statement. Four questions must be answered correctly to receive the educational credit. 4. Mail this completed form with a check for $10 to: Foundation for Rehabilitation Education and Research 1835 Rohlwing Rd., Ste. E, Rolling Meadows, IL 60008

Questions: For which educational credit (1 hour) are you applying? CCM ID#___________ CRC ID#___________

CDMS ID#__________

1. Clinical advantages of low molecular weight heparin (LMWH) over intravenous unfractionated heparin include: _____A. Greater bioavailability _____B. More predictable dose response _____C. Longer half-life _____D. All of the above 2. The following is not true about LMWH: _____A. LMWH do not require routine monitoring. _____B. The use of LMWH can reduce length of stay. _____C. LMWH usually is given intravenously. _____D. All of the above 3. If a patient has private insurance, enoxaparin sodium can be covered under drug benefits or as a major medical benefit. _____A. True _____B. False 4. A patient has Medicare Part A only. Enoxaparin sodium will be covered. _____A. True _____B. False 5. A patient does not have any insurance coverage. You have the following options: _____A. Ask the patient to pay for the enoxaparin sodium _____B. Assess if the patient qualifies for a patient assistance program _____C. Assess if the patient qualifies for your institution's charity program(if one is available) _____D. All of the above

Name ______________________________________________________________________________________________________ Address ____________________________________________________________________________________________________ City ___________________________________________________ State __________________ ZIP ________________________ Signature ___________________________________________________________________________________________________ An individual application and $10 payment must accompany each request. Applicants who do not score 80% or higher may reapply with another application and additional $10 payment. No refunds will be issued for the $10 processing fee, regardless of the certification an applicant holds. Documentation of credit and an approval number will be mailed from the foundation in 3 to 4 weeks. Credit available from September 11 to November 30. September/October 2002

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