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Hospital inpatient settings of care — coverage and reimbursement

This guide includes general descriptions of coding, billing, coverage, and reimbursement matters related to the use of Activase (Alteplase) and is provided for informational purposes only. Please consult Centers for Medicare & Medicaid Services or other payers to verify appropriate codes and learn about payer coverage policies, reimbursement rates, or billing requirements. The submission and completion of reimbursement- or coverage-related documentation are the responsibility of the patient and healthcare provider. Genentech, Inc. and its subsidiaries make no representation or guarantees concerning reimbursement or coverage for any service or item.

When a patient is admitted to a hospital for at least an overnight stay, the patient is considered an "inpatient." The two predominant inpatient payment mechanisms among public and private insurers are diagnosis-related groups (DRGs) and per diems. A third payment system, cost- or charge-based payment, is becoming increasingly rare.

  • DRGs: DRGs were first used by Medicare in 1983 but have been adopted widely by other public and private insurers. DRGs are predetermined, bundled payments for almost all care provided for a single patient stay, but do not include payment for physician services. The payment amount is based on the patient's diagnoses and the procedures performed during hospitalization.
  • Per diems: Private insurers and some Medicaid agencies use per diems. Per diem rates are predetermined, bundled daily payments for almost all care provided for a single patient stay, but do not include payment for physician services.

The following provides more detailed information on coverage and reimbursement as it relates to the inpatient setting.

Medicare hospital inpatient payment overview (DRGs)

Medicare established the inpatient prospective payment system (IPPS) to provide payment to hospitals for the treatment of Medicare beneficiaries in the hospital inpatient setting. Under the IPPS system, each hospital inpatient stay is assigned to a DRG based on the patient's characteristics and the procedures performed during his or her inpatient stay. Medicare then pays the hospital a prospectively determined amount that is associated with the DRG selected.

Each case is assigned to a DRG according to:

  • Patient's diagnoses (identified by ICD-9-CM diagnosis codes)
  • Procedures performed (identified by ICD-9-CM procedure codes)
  • Complications and comorbidities that occurred during the stay (identified by ICD-9-CM diagnosis codes)
  • Patient demographics (age and sex), and
  • Patient discharge status (alive, deceased, discharged, or transferred for further treatment)

Beginning October 1, 2007, Medicare expanded the number of DRGs to 745 in order to better reflect the severity of cases within particular DRGs. The resulting DRGs are termed Medicare severity DRGs, or MS-DRGs. Individual cases may be assigned to a DRG reflecting greater severity on the basis of whether the patient exhibits one or more of an extensive list of complications and comorbidities (CCs) or major complications and comorbidities (MCCs).

The MS-DRG payment amount is an all-inclusive, fixed payment that is intended to cover practically all of the facility's services during the hospital stay. A hospital receives only one MS-DRG payment for all covered services; the hospital must accept this payment as payment in full. Payment for virtually all drugs, devices, and supplies is included in the MS-DRG payment amount. Exceptionally high-cost cases may qualify for outlier payments. Additionally, services of physicians are not included in the MS-DRG and are paid separately.

Private payers and some Medicaid programs may provide coverage and reimbursement for patients under DRG-like systems which provide a single bundled payment for each inpatient stay.


Hospital inpatient payment overview (per diem)

A per diem is a single payment for a day of inpatient care. For example, if a patient is in the hospital for 5 days, the hospital will receive 5 times the per diem payment amount. As with the DRG system, hospitals bear the financial risk for the care that they provide. Payment for drugs, devices, and supplies are typically included in the per diem amount. Some exceptions are made for very expensive products. Physician services typically are not included and are paid separately. Some payers use a single per diem for all types of services; other payers use multiple per diems, including medical-surgical, maternity, and intensive care. The per diem system is popular among private health plans. Some state Medicaid programs also rely on per diems. Coverage and reimbursement may vary by private payer or state Medicaid program.

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Acute ischemic stroke
Indication

Activase (Alteplase) is indicated for the management of acute ischemic stroke in adults for improving neurological recovery and reducing the incidence of disability. Treatment should only be initiated within 3 hours after the onset of stroke symptoms, and after exclusion of intracranial hemorrhage by a cranial computerized tomography (CT) scan or other diagnostic imaging method sensitive for the presence of hemorrhage (see CONTRAINDICATIONS).

Safety Information
Activase therapy in patients with AIS is contraindicated in certain situations (eg, suspicion of subarachnoid hemorrhage on pretreatment evaluation, recent (within 3 months) intracranial or intraspinal surgery, history of intracranial hemorrhage, uncontrolled hypertension at time of treatment, active internal bleeding, known bleeding diathesis (eg, current use of oral anticoagulants, administration of heparin within 48 hours of onset of stroke, platelet count <100,000) (see CONTRAINDICATIONS for full list).

The most common complication during Activase therapy is bleeding. Should serious bleeding in a critical location (intracranial, gastrointestinal, retroperitoneal, pericardial) occur, Activase therapy should be discontinued immediately. Death and permanent disability are not uncommonly reported in patients who have experienced stroke (including intracranial bleeding) and other serious bleeding episodes.

The risks of Activase therapy may be increased and should be weighed against the anticipated benefits in certain conditions. [See WARNINGS in full prescribing information].

  • Patients with severe neurological deficit (eg, NIHSS >22) at presentation. There is an increased risk of intracranial hemorrhage in these patients.
  • Patients with major early infarct signs on a computerized cranial tomography (CT) scan (eg, substantial edema, mass effect, or midline shift).

Treatment of patients with minor neurological deficit or with rapidly improving symptoms is not recommended.

Orolingual angioedema has been observed in postmarketing experience in patients treated with Activase for AIS. Patients should be monitored during and for several hours after infusion for signs of orolingual angioedema.

Pulmonary embolism
Indication

Activase (Alteplase) is indicated in the management of acute massive pulmonary embolism (PE) in adults: (1) for the lysis of acute pulmonary emboli, defined as obstruction of blood flow to a lobe or multiple segments of the lungs; (2) for the lysis of pulmonary emboli accompanied by unstable hemodynamics, eg, failure to maintain blood pressure without supportive measures. The diagnosis should be confirmed by objective means, such as pulmonary angiography or noninvasive procedures such as lung scanning.

Safety Information
Activase therapy in patients with pulmonary embolism (PE) is contraindicated in certain situations because of an increased risk of bleeding (eg, active internal bleeding, history of cerebrovascular accident, recent intracranial or intraspinal surgery or trauma, severe uncontrolled hypertension) [See CONTRAINDICATIONS in the full prescribing information].

The most common complication during Activase therapy is bleeding. Should serious bleeding in a critical location (intracranial, gastrointestinal, retroperitoneal, pericardial) occur, Activase therapy should be discontinued immediately, along with any concomitant therapy with heparin.

The risks of Activase therapy for all approved indications may be increased and should be weighed against the anticipated benefits in certain conditions [See WARNINGS in full prescribing information].

Treatment of PE with Activase has not been shown to constitute adequate clinical treatment of underlying deep vein thrombosis. The possible risk of reembolization due to the lysis of underlying deep venous thrombi should be considered.

Please click here for full prescribing information.