New Medicare Coding Announced for Infusion Services; Fulfills CMS Commitment to Appropriate Reimbursement; REMICADE Receives Access to Cancer Code.

MALVERN, Pa. -- Centocor said that the new Medicare physician reimbursement policy announced yesterday by the Centers for Medicare and Medicaid Services (CMS) will facilitate increased patient access to REMICADE in a health care provider's office. REMICADE (R) (infliximab) is Centocor's treatment for rheumatoid arthritis (RA) and Crohn's disease.

CMS yesterday released the new coding and reimbursement policies for complex IV infusion services as part of its final rule on the 2005 Medicare Physicians' Fee Schedule (MPFS). Updated annually based on a formula defined in law, the MPFS establishes payment policies and payment rates for over 7,000 procedures that are performed by physicians and by certain non-physician practitioners.

The new coding takes effect January 1, 2005 and will result in physician reimbursements that better account for physicians' resources, expertise and time associated with administering REMICADE and other complex IV infusions. This coding policy change establishes that rheumatologists, gastroenterologists and other specialists will receive the same Medicare reimbursement as oncologists for providing the same type of infusion treatment services to patients.

This change in Medicare coding policy reflects the leadership of advocates throughout the medical community, including the American Medical Association, the American Society of Clinical Oncology, the American College of Rheumatology, the American College of Cardiology, the American Gastroenterology Association, the American College of Gastroenterology, the Coalition of State Rheumatology Organizations, and many individual physicians and patients across the country.

According to Greg Schmizzi, M.D., Chairman of the Coalition of State Rheumatology Organizations (CSRO), a national coalition of community-based physicians, the CMS policy update allows physicians and their patients greater choice in therapy. "Cost of treatment should never be a factor in determining care. CMS has expanded physician reimbursement options and is attempting to create fair reimbursement across all specialties for similarly complex therapies, including the administration of biologic agents," Schmizzi said.

"The new coding represents an important advance in the appropriate reimbursement for infusion services associated with providing complex infusions, including REMICADE therapy. It is good news for the health care providers who administer REMICADE and the patients who rely on it to treat rheumatoid arthritis and Crohn's disease," said Tom Schaible, Centocor's Vice President, Medical Affairs. "We commend CMS for taking the unusual step of moving the changes up by one year, in order to address concerns about adequate reimbursement for physicians under the new Part B drug reimbursement rules. As a result, the new CMS coding and policy clarifications may help more patients gain access to complex IV infusion services at a physician's office instead of having to pursue outpatient treatment at a hospital."

CMS clarified that health care providers may bill and be reimbursed for multiple infusion services provided during a single encounter. CMS also made clear that the management of significant adverse reactions experienced during complex IV infusions can be billed under the appropriate evaluation and management codes.

"Questions over reimbursement for our services have been addressed by CMS through an expedited process," said Schmizzi. "Rheumatologists can now expect some improvement in reimbursement for the services they provide to patients suffering from debilitating diseases," he added.

REMICADE is the global market leader among anti-tumor necrosis factor alpha (TNF-a) therapies and the only agent approved for the treatment of both RA and Crohn's disease in North America, the European Union and Japan. Unlike self-administered therapies that require patients to make frequent injections without the assistance of a trained medical professional, REMICADE is the only anti-TNF biologic consistently administered by health care providers in the clinic or office setting.

About REMICADE

REMICADE is the global market leader among anti-tumor necrosis factor alpha (TNF-a) therapies and the only agent approved for the treatment of both RA and Crohn's disease in North America, the European Union and Japan, and was the first biologic approved for ankylosing spondylitis in the European Union. In the EU, REMICADE is indicated for the treatment of ankylosing spondylitis in patients who have severe axial symptoms, elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy.

In September, the European Commission gave approval for expanded labeling for REMICADE, in combination with methotrexate, for the treatment of active and progressive psoriatic arthritis in patients who have responded inadequately to disease modifying anti-rheumatic drugs.

REMICADE is unique among available anti-TNF biologic therapies. Unlike self-administered therapies that require patients to inject themselves frequently, REMICADE is the only anti-TNF biologic administered directly by caregivers in the clinic or office setting. In RA and CD patients, REMICADE is a two-hour infusion administered every eight weeks, following a standard induction regimen that requires treatment at weeks 0, 2 and 6. As a result, REMICADE patients may require as few as six treatments each year. The safety and efficacy of REMICADE have been well established in clinical trials over the past 12 years and through commercial experience with more than a half million patients treated worldwide.

Important Information

Many people with heart failure should not take REMICADE; so prior to treatment you should discuss any heart condition with your doctor.

Tell your doctor right away if you develop new or worsening symptoms of heart failure (such as shortness of breath or swelling of your ankles or feet).

There are reports of serious infections, including tuberculosis (TB) and sepsis. Some of these infections have been fatal. Tell your doctor if you have had recent or past exposure to people with TB.

Your doctor will evaluate you for TB and perform a skin test. If you have latent (inactive) TB, your doctor should begin TB treatment before you start REMICADE. REMICADE can lower your ability to fight infections, so if you are prone to or have a history of infections, or develop any signs of an infection such as fever, fatigue, cough, or the flu while taking REMICADE, tell your doctor right away. Also tell your doctor if you have lived in a region where histoplasmosis or coccidioidomycosis is common. Blood disorders have been reported, some fatal. Tell your doctor if you develop possible signs of blood disorders such as persistent fever, bruising, bleeding, or paleness while taking REMICADE. Nervous system disorders have also been reported. Tell your doctor if you have or have had a disease that affects the nervous system, or if you experience any numbness, weakness, tingling, or visual disturbances while taking REMICADE. Reports of lymphoma (a type of cancer) in patients on REMICADE and other TNF blockers are rare but occur more often than in the general population. Tell your doctor if you have or have had cancer.

Serious infusion reactions have been reported with REMICADE, including hives, difficulty breathing, and low blood pressure. Reactions have occurred during or after infusions. In clinical studies, some people experienced the following common side effects: respiratory infections (that may include sinus infections and sore throat), coughing, and stomach pain or mild reactions to infusion such as rash or itchy skin.

About Centocor

Centocor is a leading biomedicines company that creates, acquires and markets cost-effective therapies that yield long-term benefits for patients and the health care community. The company is dedicated to the research and development of treatments for a wide range of Immune-Mediated Inflammatory Disorders (I.M.I.D.), such as arthritis and inflammatory skin diseases, and for cancer. Centocor's products, developed primarily through monoclonal antibody technology, help physicians deliver innovative treatments to improve human health and restore patients' quality of life. Centocor is a wholly owned subsidiary of Johnson & Johnson, the worldwide manufacturer of health care products.