Reimbursement for Anticoagulation Services

Journal of Thrombosis and Thrombolysis 12(1), 73 79, 2001. # 2002 Kluwer Academic Publishers, Manufactured in The Netherlands. Reimbursement for Anticoagulation Services Paul W. Radensky McDermott, Will & Emery, Miami FL Key Words. reimbursement, anticoagulation services, Medicare The Basics of Reimbursement for Anticoagulation Services: Coverage, Payment, and Coding To determine how anticoagulation services will be paid, one must consider three issues: (1) coverage policy, (2) payment policy, and (3) coding. Coverage policy determines whether anticoagulation services are eligible for payment under the terms of the benefit plan. For public payers (e.g., Medicare and Medicaid), coverage is determined by statute. For private payers, coverage is determined by contract (benefit plan agreements) under requirements set out by state or federal law. Payment policy determines how the allowed payments are determined and what, if any, copayments or coinsurance will apply. Coding is the language providers use to tell payers what they have done and why.* To be eligible for coverage, a service must be included under the scope of benefits and not otherwise excluded. The benefits under most benefit plans are described broadly and include hospital, physician, clinical laboratory, home health, and skilled nursing facility services. The scope of benefits under Medicare is set out in the Social Security Act. Anticoagulation services are not listed specifically under the scope of benefits. Anticoagulation services may include physician services for evaluating a patient on therapy, obtaining blood specimens, and for administration of a low molecular weight heparin; clinical laboratory services for monitoring prothrombin time (PT) levels; hospital services if the patient is evaluated and managed in a hospital setting; skilled nursing facility services if the patient is managed in that setting; and home health agency services if the patient is managed at home. Home prothrombin time (PT) monitors meet the criteria for durable medical equipment (DME), a separately listed item under the scope of benefits. Some, but not all, benefit plans include outpatient prescription drugs. Medicare does not cover outpatient prescription drugs generally. Coverage under Medicare is limited to drugs that are not usually self-administered by the patient. Therefore, a drug like warfarin is not covered under Medicare because it is not included under the scope of benefits. Warfarin may be covered under certain Medicare supplement policies (NAIC standard plans H, I, J). A low molecular weight heparin (LMWH) may be covered under Medicare when administered by a physician or hospital but would not be covered when selfadministered by a patient. Exclusions may apply two ways: (1) to all beneficiaries at all times (that is, the item or service is never covered) or (2) to specific beneficiaries or under specific circumstances. Some items are specifically excluded (e.g., hearing aids). Anticoagulation services are not specifically excluded. Other items may be excluded because the payer considers the item or service to be investigational or experimental. Under these circumstances, the payer will deny coverage whenever the item or service is ordered. For example, the Medicare Durable Medical Equipment Regional Carriers (DMERCs) have denied coverage for home PT testing because the DMERCs believe that the benefits of home testing have not been proved. CMS s Coverage and Analysis Group is reviewing the evidence on this issue and is expected to issue a coverage decision allowing coverage in 2001. Items and services that are generally covered also must be considered medically necessary for the specific patient at the specific time. A payer may determine that it is medically necessary to order a PT test every 3 to 4 weeks, for example, but not every 3 to 4 days. The payment policies that apply to covered items and services vary by the setting where the service is provided. Under Medicare, there Address for correspondence: Paul W. Radensky, M.D. 201 South Biscayne Boulevard, 22nd Floor, Miami, FL 33131-4336. E-mail: pradensky@mwe.com * The policies under Medicare are publicly available and directed nationally by the Centers for Medicare and Medicaid Services (CMS). By contrast, the policies among private payers vary widely and also differ among the 50 state Medicaid programs. Therefore, this summary primarily presents information on Medicare policies. 73

74 Radensky are several prospective payment systems that define how Medicare sets the payment rate for anticoagulation services. Hospital inpatient services are paid under the per-admission all inclusive Diagnosis Related Group (DRG) rates. Medicare payment is the same, for example, for an admission to manage a patient with deep venous thrombosis whether the patient is treated with unfractionated heparin (UFH) or a low molecular weight heparin (LMWH). Hospital outpatient services, such as emergency department visits or outpatient clinic visits are paid under the Hospital Outpatient Prospective Payment System (HOPPS), which provides a packaged payment for procedures performed in the hospital outpatient setting under Ambulatory Payment Classification (APC) rates. Physician services are paid under the Resource Based Relative Value Scale (RBRVS) fee schedule. Prothrombin time tests are paid under the clinical laboratory fee schedule. Home health agency services are paid under the Home Health Prospective Payment System. DME, such as the home PT testing monitors, are paid under the Durable Medical Equipment, Prosthetics, and Orthotic Supplies (DMEPOS) fee schedule. Several coding systems are used to report services on claim forms. Procedures are generally reported using the American Medical Association s Current Procedural Terminology (CPT) codes. Office visits, PT tests, venipuncture, and administration of injectable drugs are all reported using CPT codes. Injectable drugs, such as LMWHs, and DME are reported using the alpha-numeric HCFA Common Procedure Coding System (HCPCS) codes. Providers report the reason for providing services using the International Classification of Diseases 9th Revision Clinical Modification (ICD-9-CM) codes. Coverage Payment and Coding for Oral Anticoagulation Management Visits Consider a patient who is on chronic oral anticoagulation. The patient will be seen at regular intervals and the following services may be provided: (1) PT testing, (2) specimen collection, and (3) evaluation and management. PT testing performed in the outpatient setting is covered and paid under the Clinical Laboratory Fee Schedule. The test is coded using CPT 85610: Prothrombin time. If the test is performed in a physician office laboratory that has a certificate of waiver under the Clinical Laboratory Improvement Amendments (CLIA), the test must be performed using a waived test device and reported using the QW modifier following the CPTcode for the test. The 2001 Clinical Laboratory Fee Schedule payment for PT testing is $5.43 (national limitation amount). PT testing performed in an inpatient setting would be included in the rate paid to the facility for the admission, with no separate payment made for the test. Specimen collection by venipuncture may be paid separately under HCPCS G0001 routine venipuncture for collection of specimens at a 2001 payment amount of $3.00 (2001 midpoint). Medicare will not pay for fingerstick sample collection. Private payers may pay for venipuncture or fingerstick sample collection under CPT 36415 routine venipuncture or finger=heel=ear stick for collection of specimen(s). Evaluation and management office visit services are also covered when medically necessary and the services actually provided meet the intensity of services described by the CPT code for each type of service. Evaluation and management office visit service codes and payment amounts are shown in Table 1 for new patients and in Table 2 for established patients. New patients are those who have not received any face-to-face service by the physician within the past 3 years. For multispecialty groups, if the patient has been seen by a physician in the same specialty within 3 years, the patient is an established patient. For the purposes of determining new versus established patients, simply performing a PT test or interpretation of an ECG is not a face-to-face service that would result in a patient being an established patient. Table 1. Evaluation and Management Office Visit Service Codes and 2001 Medicare Fee Schedule Payments for New Patients Code 1 99201 99202 99203 99204 99205 History Problem Expanded problem Detailed Comprehensive Comprehensive Exam Problem Expanded problem Detailed Comprehensive Comprehensive Medical Decision Straight-forward Straight-forward Low complexity Moderate High complexity Making complexity Problem severity Minor=self-limited Low to moderate Moderate Moderate to high Moderate to high Face-to-face time 10 minutes 20 minutes 30 minutes 45 minutes 60 minutes Payment (Office) 2 $35.58 $61.98 $91.44 $132.76 $167.57

Reimbursement 75 Table 2. Evaluation and Management Office Visit Service Codes and 2001 Medicare Fee Schedule Payment Amounts for Established Patients Code 1 99211 99212 99213 99214 99215 History Not defined Problem Expanded problem Detailed Comprehensive Exam Not defined Problem Expanded problem Detailed Comprehensive Medical Not defined Straight-forward Low complexity Moderate High complexity Decisision Making complexity Problem severity Minimal Self-limited or minor Low to moderate Moderate to high Moderate to high Face-to-face time 5 minutes 10 minutes 15 minutes 25 minutes 40 minutes Payment (Office) 2 $19.89 $35.96 $50.50 $78.81 $117.07 Evaluation and management service codes are determined by the comprehensiveness of the history and examination and the complexity of the medical decision-making required to manage the patient. The severity of the presenting problem and the time spent with the patient are also listed as guides, but the selection of appropriate evaluation and management code is not determined by the problem severity or time. For hospital-based anticoagulation management services, the facility would submit a claim for the technical or facility component service. This covers the room, equipment, supplies, and staff, excluding the physician s professional services. The hospital payment amounts are determined under the HOPPS under Ambulatory Payment Classification (APC) groups to which each CPT code is assigned. The payment amounts in the hospital outpatient setting are shown in Table 3. If a physician has a face-to-face encounter with the patient, the physician may also be paid a professional fee. The professional fee in the hospital outpatient setting is lower than the corresponding fee in the physician office setting recognizing that the physician does not bear the cost of overhead and staff in the hospital setting (Table 3). Coverage, Payment, and Coding for Administration of LMWH An outpatient encounter to evaluate a patient with deep venous thrombosis and to administer an LMWH would have the following components: (1) evaluation and management services, (2) injection of the LMWH, and (3) the LMWH drug product itself. These items and services may be provided in the physician office setting, a hospital outpatient clinic, an emergency department, or by a home health agency. In the office setting, we would have evaluation and management services under CPT 99201 99205 for new patients and 99211 99215 for established patients as shown in Tables 1 and 2. For the injection of an LMWH, the physician may report CPT 90782 Therapeutic, prophylactic or diagnostic injection (specify material injected); subcutaneous or intramuscular. The allowance under the 2001 Medicare Fee Schedule for this service is $4.59. Note, however, that payment will be made under this code only if no other fee schedule service is provided on the same day. Therefore, the physician will not be paid for the injection if an evaluation and management service visit is billed Table 3. Evaluation and Management Services in the Hospital Outpatient Department (Medicare 2001 Rates) Code: 1 New pt 99201 99202 99203 99204 99205 Hospital payment 3 APC 600 $49.24 APC 600 $49.24 APC 601 $50.24 APC 602 $83.40 APC 602 $83.40 Professional fee 2 $24.49 $47.44 $71.54 $105.59 $138.88 Code: 1 Establ pt 99211 99212 99213 99214 99215 Hospital payment 3 APC 600 $49.24 APC 600 $49.24 APC 601 $50.24 APC 602 $83.40 APC 602 $83.40 Professional fee 2 $9.56 $24.49 $35.58 $57.77 $92.97 3 http:==www.hcfa.gov=medlearn=apr00la.xls (accessed 24 June 2001).

76 Radensky on the same date. Private payer policies on payment for the injection will vary. Under Medicare, outpatient prescription drugs are generally not covered. However, drugs and biologicals, which are not usually self-administered by the patient, are covered when provided incident-to physician services or hospital services. When administered incident-to a physician s service, the payment is set at 95% of the national average wholesale price (AWP) as published by reference sources, such as Drug Topics Red Book or First Databank. As LMWHs may be self-administered, these agents are only covered when it is medically necessary for the drug to be administered by the provider. For example, physicians may determine that a patient should have the initial injection in the office to show the patient how to self-administer and to assess for any complications with the initial injection. Many local Medicare contractors have policies covering the initial injection of LMWH. In addition, some patients may not be able to self-administer at all because of physical impairment, visual limitations, or cognitive impairment. Under those circumstances, repeat injections in the physician office setting may be medically necessary. In the hospital outpatient setting, the facility may report the same services as the physician s office may report in the office setting. The evaluation and management services would be reported and paid at the rates shown in Table 3. In the hospital outpatient setting, however, APC 0359, to which injection code 90782 is assigned, has a payment rate of $48.23. Therefore, in the hospital outpatient setting payment would be nearly identical whether the service is billed as an evaluation and management service or an injection. Under HOPPS, payment for drugs is generally included in the payment for the associated procedure. However, orphan drugs, cancer chemotherapy drugs, radiopharmaceuticals, and drugs not available before 1997 are paid separately from the APC rate for the associated procedure as socalled pass-through agents. Payment for passthrough drugs is set at 95% of the published, national AWP. Among the LMWHs, enoxaparin and dalteparin were introduced before 1997, and tinzaparin was introduced in 2000. Therefore, tinzaparin should be eligible for separate reimbursement at 95% of AWP. By contrast, there is no separate payment for either enoxaparin or dalteparin. The pass-through payments will continue through January 2003 or 2004. In the emergency department setting, both the hospital and physician would report the facility and professional components services respectively. There would be an evaluation and management service, an injection, and the LMWH. Payments for the evaluation and management services are shown in Table 4. The injection service, if separately billed and payable would fall under APC 0359, as above, and the LMWH would be paid under the pass-through payment rules. When LMWH is provided in the home health setting to homebound patients, payment for the nursing service and supplies is made under the Home Health PPS. If the patient requires 5 or more skilled nursing visits within a 60-day encounter period (e.g., to assist with the administration of the LMWH, to evaluate the leg and assess for clotting or bleeding complications, and to conduct point-of-care testing of prothrombin time for adjunctive warfarin therapy), the payment would fall under one of the Home Health Resource Groups, with payment amounts ranging from $1,113.71 to $5,946.74 (unadjusted for geographic locality). If the patient requires 4 or fewer visits, the payment would be on a per visit basis under what is called the Low Utilization Payment Adjustment (LUPA). The 2001 LUPA amount for skilled nursing visits is $95.79. Table 4. Evaluation and Management Services in the Emergency Department (Medicare 2001 Rates) E&M Code 1 99281 99282 99283 99284 99285 History Problem Expanded problem Expanded problem Detailed Comprehensive Examination Problem Expanded problem Expanded problem Detailed Comprehensive Med decision making Straight-forward Low complexity Moderate complexity Moderate complexity High complexity Problem severity Self-limited or minor Low to moderate Moderate High High Facility payment 3 APC 610 $67.32 APC 610 $67.32 APC 611 $106.01 APC 612 $160.27 APC 612 $160.27 Physician payment 2 $18.75 $30.61 $64.66 $100.62 $157.24 3 http:==www.hcfa.gov=medlearn=apr00la.xls (accessed 28 June 2001).

Reimbursement 77 Incident-to Service Rules Providing high-quality anticoagulation services requires a coordinated effort among many professionals. Many of the services can appropriately be provided by physician office or hospital staff and do not require face-to-face services from the physician. For example, under physician supervision, a nurse may evaluate a patient by asking about changes in medication, diet, concurrent illnesses, or occurrence of any bleeding or clotting events, by conducting a brief examination to look for signs of bleeding or clotting, drawing a specimen to run a PT test, performing a point-of-care test, informing the patient of the results, and instructing the patient on any changes in warfarin dosing. Medicare recognizes that physicians and hospitals can provide services beyond the direct physician face-to-face encounter and these services are covered as incident-to the services of a physician, provided specific rules are followed. In the physician office setting, there are three requirements for coverage of incident-to services: (1) there must be direct personal physician supervision, (2) auxiliary personnel who personally perform services, such as nurses, nonphysician anesthetists, psychologists, technicians, therapists, including physical therapists, and other aides must be employed by the physician, and (3) the services must be furnished during a course of treatment where the physician performs an initial service and subsequent services of a frequency which reflect his=her active participation in and management of the course of treatment (Medicare Carriers Manual [MCM] 2050.1). Direct physician supervision requires that the physician be present in the office suite and be immediately available to provide assistance and direction throughout the time the non-physician is performing services. The physician need not be present in the same room, however. To meet the employed by the physician requirement, the nonphysician performing an incident-to service may be a part-time, full-time, or leased employee of the supervising physician, physician group practice, or of the legal entity that employs the physician who provides direct personal supervision. A leased employee is a nonphysician working under a written employee leasing agreement which provides that the nonphysician provides services as the leased employee of the physician; and the physician exercises control over all actions of the leased employee regarding the rendering of medical services to the same extent the physician would exercise such control if the leased employee were directly employed by the physician. Services provided by auxiliary personnel not in the employ of the physician are not covered as incident-to a physician s service since the incidental service must represent an expense incurred by the physician. To be eligible for incident-to coverage, the physician who is billing for the services must personally provide an initial service to the patient and must see the patient personally at some routine interval as medically necessary to provide adequate supervision of the patient s management. There are no specific policies as to the frequency at which physicians must personally provide follow up services. In addition to services provided by physicians or by their nonphysician staff incident-to a physician s service, anticoagulation management services may be provided by nurse practitioners, physician assistants or clinical nurse specialists, so-called advanced practice nonphysician practitioners (MCM 2050.2). These advanced practice nonphysician practitioners are licensed by the states under various programs to assist or act in the place of the physician. For services of a nonphysician practitioner to be covered as incident-to services of a physician, the services must meet all of the requirements for coverage specified above: direct personal supervision, employment, and occur during the course of treatment by the physician. In addition to providing incident-to physician services, these advanced practice professionals also may provide services directly and not under direct physician supervision. When incident-to services are provided by nonadvanced practice nonphysician professionals, Medicare policy limits the services to the lowest level evaluation and management visit: CPT 99211 (MCM 15501G). If the services are provided by advanced practice professionals, however, there is no limitation on the intensity of evaluation and management service provided as long as the services provided are within the advanced practice professional s scope of practice under state law. Payment for services provided incident-to a physician s service are paid at the full Medicare Physician Fee Schedule rate. Payment for services of advanced practice professionals performed independently (i.e., not under direct physician supervision) are paid at 85% of the Medicare Physician Fee Schedule rate. Although physician assistants may perform evaluation and management services without direct physician supervision and their services may be billed as independent services, physician assistant services can only be billed by their employer. Services incident-to physician services may also be covered in the hospital outpatient setting (Medicare Intermediary Manual 3112.4). These

78 Radensky services must be provided: (1) under physician supervision, (2) by hospital personnel, and (3) on the order of a physician who sees the patient personally during the course of treatment. In the hospital setting, when services are provided on the hospital campus, the physician supervision requirement is generally assumed to be met. The hospital medical staff that supervises the services need not be in the same department as the ordering physician. Physician supervision is not assumed, however, for off-campus facilities. (A discussion of the requirements for off-campus facilities to bill as hospital outpatient departments is beyond the scope of this paper.) Although physician supervision may be assumed for reimbursement purposes in the hospital campus setting, good medical care may require that a physician be physically close to the place where the anticoagulation management services are provided and be ready immediately to handle personally any emergency situations that arise. As discussed above for incident-to services in the physician office setting, in the hospital outpatient setting, the hospital can bill only for services provided by its personnel or personnel the hospital provides under arrangements. A physician cannot bring his or her staff to the hospital and bill under the incident-to rules for services performed by the physician s staff. If the anticoagulation management services are provided by advanced practice professionals, these professionals may bill their professional services independent from the hospital facility fee only if the salary, benefits, and expenses of the advanced practice professionals are excluded from the hospitals cost report to Medicare. As in the physician office setting, the incidentto services provided by the hospital must be during the course of care provided by a physician Table 5. Incident-to Billing in Physician Office Setting Personnel performing service Supervision required Reportable codes Payment amount Physician None 99201 99205 (new patient); 99211 99215 (esablished patient) Advanced practice professional (independent service) Advanced practice professional (incident-to-service) Non-advanced practice professional * Medicare Fee Schedule (physician services). 100 % MFS* None 99201 99205 (new patient); 99211 99215 (esablished patient) 85 % MFS* Direct physician supervision 99211 99215 100 % MFS* Direct physician supervision 99211 100 % MFS* Table 6. Incident-to Billing in Hospital Outpatient Setting Personnel performing service Supervision required Reportable codes Hospital payment amount Professional fee Physician None 99201 99205 (new patient); 99211 99215 (established patient) Advanced practice professional (not included on hospital cost report) Advanced practice professional (included on hospital cost report) Non-advanced practice professional * Medicare Fee Schedule (physician services). APC 600 APC 602 100 % MFS* None 99201 99205 (new patient); 99211 99215 (established patient) APC 600 APC 602 85 % MFS* None 99211 99215 APC 600 APC 602 Not eligible to bill for professional fee Physician supervision (assumed on campus; not assumed off-campus) 99211 APC 600 Not eligible to bill for professional fee

Reimbursement 79 who initially evaluates the patient and sees the patient periodically and sufficiently often to assess the course of treatment and the patient s progress and, where necessary, to change the treatment regimen (MIM 3112.4). A hospital service or supply would not be considered incident-to a physician s service if the attending physician merely wrote an order for the services or supplies and referred the patient to the hospital without being involved in the management of that course of treatment. The required nexus between the physician who personally sees the patients and the hospital is not defined in the regulations or policies, but it would appear that the physician referring the patient to the hospital for incident-to services must have staff privileges at the hospital. Although the general framework for considering coverage, payment and coding for incidentto services is presented above, many questions arise from those involved in providing anticoagulation management regarding incident-to services: Who can perform these services? Who can bill for the services? How much will be paid for these services? Two important issues should be considered to answer the question about who can provide incident-to services. First, one must ask whether it is appropriate for the physician to delegate the particular service that is performed by non-physician staff. Second, one must consider whether it is appropriate for the physician to delegate the specific service to the particular non-physician practitioner performing the service. These issues involve State law issues about the scope of medical practice, the scope of practice of the non-physician staff actually performing the service, and the standard of care in the community for providing these services. Of course, physicians have greater freedom to delegate services to advanced practice professionals than non-advanced practice professionals. Among nonadvanced practice professionals, the question about whether a particular service is within the scope of practice may not be clear. Under those circumstances, the physician and the nonphysician practitioner may wish to inquire of the respective licensing authorities (medical board and board of practice for the non-advanced practice staff, if any) about the appropriateness of any physician-delegated services performed under direct physician supervision. Finally, the incident-to coverage, payment, and coding rules are summarized in Tables 5 and 6. The rules, as described above, are more detailed than one easily can summarize in tabular form, however. Conclusion Proper anticoagulation can be life-saving and can avert such serious events as strokes and pulmonary emboli. Providing high quality anticoagulation services involves a coordinated effort among multiple professionals. The rules defining coverage, payment, and coding for these services are complex, but navigating through them properly will assure that anticoagulation service providers receive appropriate revenues for the services provided so they may continue to offer these much-needed services.