PROCRITline.com - Medicare OPPS Changes for 2009

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Please see full Prescribing Information, including Boxed WARNINGS, for PROCRIT^® (Epoetin alfa)

Please see full Prescribing Information, including Boxed WARNINGS, for LEUSTATIN^® (cladribine)

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Medicare Hospital Outpatient Prospective Payment System (OPPS)

OPPS Changes for 2009

Most separately payable Medicare Part B-covered drugs that are administered by physicians in the hospital outpatient setting will be reimbursed at a rate of ASP plus 4 percent in 2009.

That was one of several provisions finalized in the Medicare Hospital Outpatient Prospective Payment System (OPPS) for fiscal year 2009. The changes are effective from January 1, 2009 to December 31, 2009.

CMS updated the conversion factor for the OPPS in 2009 to $66.059, resulting in a market basket increase update factor of 3.6 percent over 2008. However, hospitals that fail to meet quality-reporting requirements under the Hospital Outpatient Quality Data Reporting Program (HOP QDRP) will have a reduced conversion factor of $64.784, meaning that they will be eligible for a Medicare payment increase of just 1.6 percent over 2008 level.¹

¹Federal Register, Vol. 73 No. 223, Tuesday, November 18, 2008, Rules and Regulations.

Important Safety Information for PROCRIT^® (Epoetin alfa)

WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR EVENTS, THROMBOEMBOLIC EVENTS, STROKE and INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE

Chronic Renal Failure:

In clinical studies, patients experienced greater risks for death, serious cardiovascular events, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target hemoglobin levels of 13 g/dL and above.

Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.

Cancer:

ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in some clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers (see WARNINGS: Table 1).

To decrease these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusion.

Because of these risks, prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense PROCRIT^® to patients with cancer. To enroll in the ESA APPRISE Oncology Program, visit www.esa-apprise.com or call 1-866-284-8089 for further assistance.

Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy.

ESAs are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure.

Discontinue following the completion of a chemotherapy course.

Perisurgery: PROCRIT^® (Epoetin alfa) increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.

(See WARNINGS: Increased Mortality, Serious Cardiovascular Events, Thromboembolic Events, and Stroke, WARNINGS: Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence, INDICATIONS AND USAGE, and DOSAGE AND ADMINISTRATION.)

Please see full Prescribing Information, including Boxed WARNINGS for PROCRIT^® (Epoetin alfa)

Medication Guide for PROCRIT^®
Please read the Medication Guide for PROCRIT^® and discuss with your doctor.

Patient Instructions for Use
Instructions if you or your caregiver has been trained to give PROCRIT^® injections at home.

Boxed WARNINGS: LEUSTATIN^® (cladribine) Injection

LEUSTATIN (cladribine) Injection should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. Suppression of bone marrow function should be anticipated. This is usually reversible and appears to be dose dependent. Serious neurological toxicity (including irreversible paraparesis and quadraparesis) has been reported in patients who received LEUSTATIN Injection by continuous infusion at high doses (4 to 9 times the recommended dose for Hairy Cell Leukemia). Neurologic toxicity appears to demonstrate a dose relationship; however, severe neurological toxicity has been reported rarely following treatment with standard cladribine dosing regimens.

Acute nephrotoxicity has been observed with high doses of LEUSTATIN (4 to 9 times the recommended dose for Hairy Cell Leukemia), especially when given concomitantly with other nephrotoxic agents/therapies.

Please see full Prescribing Information, including Boxed WARNINGS for LEUSTATIN^® (cladribine)