REMICADE® (infliximab) - Billing and Reimbursement

REMICADE^® (infliximab) and Medicare

Overview of Medicare

Medicare is a federal program that typically provides health insurance coverage to the following types of people:

	People over age 65 with a work history
	Individuals with certain disabilities who have been disabled for at least 2 years
	Individuals diagnosed with End Stage Renal Disease (ESRD)

While Medicare covers many healthcare needs, it may not cover all of the patient's healthcare costs. The patient may have to pay a monthly premium for Medicare and then pay a co-insurance and deductible for many services.

Medicare Coverage of REMICADE

Medicare covers most physician-administered drugs like REMICADE under Medicare Part B. There are comprehensive published Part B coverage policies specific to REMICADE. Copies of coverage policies are available on your regional Medicare Administrative Contractor (MAC) websites, and these can be found in the Billing and Reimbursement section of this website.

Medicare typically places few restrictions on REMICADE coverage. Some Medicare policies may limit coverage of REMICADE to certain diagnoses, such as:

	Crohn's Disease
	Ulcerative Colitis
	Rheumatoid Arthritis
	Ankylosing Spondylitis
	Psoriatic Arthritis
	Plaque Psoriasis

You can check your regional MAC website for coverage policies for REMICADE or call AccessOne^® at 1-888-ACCESS-1 (222-3771) for more assistance.

The Four Parts of Medicare

Medicare is divided into four parts: A, B, C, and D. Part A covers facility care such as hospitals, Part B covers physician and other outpatient services. Part C, which is known as the Medicare Advantage program, allows private managed care plans to administer the patient's Medicare benefits.

Medicare Part D offers prescription drug coverage to anyone enrolled in Medicare Parts A or B. The table below provides additional detail regarding the four parts of the Medicare Program.

Table 1. The Four Parts of Medicare

Part A Typically known as the hospital benefit, Part A provides coverage for services such as hospitalizations, hospice care, skilled nursing facility stays, and home health services.	Part B Part B benefits provide reimbursement for physician services, clinical laboratory services, hospital outpatient services, prescription drugs administered "incident to" a physician's services, durable medical equipment, and some home health services.
Part C Also known as Medicare Advantage, this benefit provides Medicare through managed care plans.	Part D Prescription drug coverage for medicines that are usually self-administered or taken orally.

To learn more about the different parts of Medicare, you can call the Medicare Program at (800) MEDICARE or visit www.medicare.gov.

Changes in Medicare for 2010

There are several important changes to the Medicare program for 2010. These may affect providers and patients and include:

Changes in patient costs for Medicare coverage and services

It will be important to monitor the Medicare program in 2010 because additional changes may go into affect throughout the year.

Patient Costs for Medicare in 2010

In 2010, Medicare beneficiaries will have to pay for some of their healthcare costs. The 2010 premium, deductible, and co-insurance amounts for Medicare beneficiaries are listed below:

Part A (Inpatient Hospital, Skilled Nursing Care)¹

Most Medicare beneficiaries do not pay a monthly premium for Part A coverage. However, they may have to pay a deductible for inpatient hospital stays, skilled nursing facility stays, and some home health services. For each benefit period Medicare pays all covered costs except the Medicare Part A deductible. For each benefit period the patient pays:

	A total of $1100 for a hospital stay of 1-60 days
	For days 61 through 90, the patient is responsible for an additional $275 each day per day
	For days 91 through 150, the patient is responsible for an additional $550 each day per day
	For days beyond 150, the patient is responsible for all costs

Part B (Physician Services, Outpatient Hospital Services, Certain Home Health Services, Durable Medical Equipment)¹

In 2010, the monthly fee or premium for Medicare Part B is based on your income. Most people will pay the standard monthly Part B premium of $110.50. However, some people will pay a higher premium if their modified adjusted gross income is more than $85,000 for an individual or $170,000 for a married couple. These amounts change each year. There is also a $155.00 per year deductible. After the patient meets the deductible, they pay 20% of the Medicare-approved amount for services.

Part C (Medicare Advantage)

Because these plans offer a variety of coverage, the patient's cost-share (e.g., co-insurance, deductibles, premiums) can vary from plan to plan. You should check with the specific Medicare Advantage plan to find out what the patient costs will be.

Part D (Prescription Drugs)

People with Medicare that enroll in Part A or Part B have the option to join Medicare Part D, which provides prescription drug coverage. Patients usually pay an additional monthly fee or premium for Medicare Part D prescription drug coverage and will likely have other cost-sharing responsibilities like a co-payment and deductible.

Costs Associated with Medicare Part D Prescription Drug Coverage

People with Medicare Part D will pay an average monthly fee or premium of $30.00 in 2010². After a $310 deductible, the patient will pay 25% of the next $2,830 in prescription drug costs. Then the patient is responsible for 100% of the next $3,610.00 in prescription drug costs. The patient is responsible for 5% of all additional prescription drug costs above $6,440.00.

For more details about the costs of Medicare coverage³, please call the Medicare Program at (800) MEDICARE or visit www.medicare.gov.

Most Medicare Part D prescription drug plans have a formulary or list of drugs that are covered. These plans also have networks of pharmacies where patients can fill their prescriptions at lower costs. The plans may also offer mail-order benefits so patients can have their drugs shipped directly to their homes.

Medicare Supplemental Coverage

Most patients that have Medicare also have some type of secondary insurance coverage. This secondary coverage may be an employer-sponsored plan, Medigap plan, or Medicaid program. These plans offer a wide variety of supplemental coverage to Medicare. For example, Medigap plans may cover some or all of a patient's 20 percent co-insurance and deductible for administration of REMICADE provided through Medicare Part B. However, Medigap plans typically do not provide this type of coverage for REMICADE if it is provided under the Part D prescription drug benefit.

Coding Update for Disaster Victim Services

In order to track and facilitate claims processing of claims for disaster victims, the Centers for Medicare and Medicaid Services (CMS) established a national modifier and condition code:

CR, Catastrophic/Disaster Related
DR, Disaster Related

Any provider may use the modifier. MACs use either the modifier or the condition code. The condition code would identify claims that are or may be impacted by specific payer policies related to a national or regional disaster. The modifier indicates a specific Part B service that may be impacted by a policy related to the disaster.

For additional information regarding Disaster Victim Services, please contact Medicare at (800) MEDICARE or visit www.medicare.gov or www.cms.hhs.gov.

¹ CMS Announces Medicare Premiums, Deductibles for 2010, accessed November 12, 2009. CMS Office of Public Affairs.
² Robust Medicare Health and Drug Plan Coverage Continues in 2010, Beneficiary Protections Strengthened, accessed November 12, 2009. CMS Office of Public Affairs.
³ CMS Announces 2010 Payment Information for Part C Medicare Advantage Plans and Part D Prescription Drug Plans. CMS Office of Public Affairs. April 6, 2009.

INDICATIONS AND IMPORTANT SAFETY INFORMATION

Indications for REMICADE^® (infliximab)

Rheumatoid Arthritis

REMICADE^®, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis.

Crohn's Disease

REMICADE^® is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult and pediatric patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy.

REMICADE^® is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn's disease.

Ankylosing Spondylitis

REMICADE^® is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.

Psoriatic Arthritis

REMICADE^® is indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis.

Plaque Psoriasis

REMICADE^® is indicated for the treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. REMICADE^® should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

Ulcerative Colitis

REMICADE^® is indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.

IMPORTANT SAFETY INFORMATION

RISK OF INFECTIONS

Patients treated with REMICADE^® (infliximab) are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue REMICADE^® if a patient develops a serious infection or sepsis.

Reported infections include:

Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before and during treatment with REMICADE^®.^{1, 2} Treatment for latent infection should be initiated prior to treatment with REMICADE^®.
Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, and pneumocystosis. Patients may present with disseminated, rather than localized, disease. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
Bacterial, viral, and other infections due to opportunistic pathogens.

The risks and benefits of treatment with REMICADE^® should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with REMICADE^®, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

In clinical trials, other serious infections observed in patients treated with REMICADE^® included pneumonia, cellulitis, abscess, and skin ulceration.

MALIGNANCIES

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including REMICADE^®. Approximately half of these cases were lymphomas, including Hodgkin's and non-Hodgkin's lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants.

Postmarketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including REMICADE^®. These cases have had a very aggressive disease course and have been fatal. All reported REMICADE^® cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. All of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with REMICADE^® at or prior to diagnosis. Carefully assess the risks and benefits of treatment with REMICADE^®, especially in these patient types.

In clinical trials of all TNF inhibitors, more cases of lymphoma were observed compared with controls and the expected rate in the general population. However, patients with Crohn's disease, rheumatoid arthritis, or plaque psoriasis may be at higher risk for developing lymphoma. In clinical trials of some TNF inhibitors, including REMICADE^®, more cases of other malignancies were observed compared with controls. The rate of these malignancies among patients treated with REMICADE^® was similar to that expected in the general population whereas the rate in control patients was lower than expected. Cases of acute and chronic leukemia have been reported with postmarketing TNF-blocker use. As the potential role of TNF inhibitors in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy or other risk factors such as chronic obstructive pulmonary disease (COPD).

CONTRAINDICATIONS

REMICADE^® is contraindicated in patients with moderate to severe (NYHA Class III/IV) congestive heart failure (CHF) at doses greater than 5 mg/kg. Higher mortality rates at the 10 mg/kg dose and higher rates of cardiovascular events at the 5 mg/kg dose have been observed in these patients. REMICADE^® should be used with caution and only after consideration of other treatment options. Patients should be monitored closely. Discontinue REMICADE^® if new or worsening CHF symptoms appear. REMICADE^® should not be (re)administered to patients who have experienced a severe hypersensitivity reaction or to patients with hypersensitivity to murine proteins or other components of the product.

HEPATITIS B REACTIVATION

TNF inhibitors, including REMICADE^®, have been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases were fatal. Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating REMICADE^®. Exercise caution when prescribing REMICADE^® for patients identified as carriers of HBV and monitor closely for active HBV infection during and following termination of therapy with REMICADE^®. Discontinue REMICADE^® in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of REMICADE^® and monitor patients closely.

HEPATOTOXICITY

Severe hepatic reactions, including acute liver failure, jaundice, hepatitis, and cholestasis have been reported rarely in patients receiving REMICADE^® postmarketing. Some cases were fatal or required liver transplant. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (e.g., > 5 times the upper limit of normal) develop, REMICADE^® should be discontinued, and a thorough investigation of the abnormality should be undertaken.

HEMATOLOGIC EVENTS

Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia (some fatal) have been reported. The causal relationship to REMICADE^® therapy remains unclear. Exercise caution in patients who have ongoing or a history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infection. Consider discontinuation of REMICADE^® in patients who develop significant hematologic abnormalities.

HYPERSENSITIVITY

REMICADE^® has been associated with hypersensitivity reactions that differ in their time of onset. Acute urticaria, dyspnea, and hypotension have occurred in association with infusions of REMICADE^®. Serious infusion reactions including anaphylaxis were infrequent. Medications for the treatment of hypersensitivity reactions should be available.

NEUROLOGIC EVENTS

TNF inhibitors, including REMICADE^®, have been associated with rare cases of new or exacerbated symptoms of demyelinating disorders including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome, seizure, and CNS manifestations of systemic vasculitis. Exercise caution when considering REMICADE^® in all patients with these disorders. Consider discontinuation for significant CNS adverse reactions.

AUTOIMMUNITY

Treatment with REMICADE^® may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.

ADVERSE REACTIONS

In clinical trials, the most common REMICADE^® adverse reactions occurring in >10% of patients included infections (e.g. upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain.

USE WITH OTHER DRUGS

The concomitant use of a TNF blocker and anakinra was associated with a higher risk of serious infections, therefore the use of REMICADE^® in combination with anakinra is not recommended. Live vaccines should not be given with REMICADE^®. Bring pediatric Crohn's patients up to date with all vaccinations prior to initiating REMICADE^®.

Please read full Prescribing Information and Medication Guide for REMICADE^®. Provide the Medication Guide to your patients and encourage discussion.

References:	1.	American Thoracic Society, Centers for Disease Control and Prevention. Targeted tuberculin testing and treatment of latent tuberculosis infection. Am J Respir Crit Care Med. 2000;161:S221-S247.
	2.	See latest Centers for Disease Control guidelines and recommendations for tuberculosis testing in immunocompromised patients.

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Indications for REMICADE® (infliximab)