Immune Globulin: A Guide to Billing and Reimbursement

By Ronale Tucker Rhodes, MS, Leslie Vaughan, RPh, and Michelle Greer, RN

Immune globulin (IG) is a U.S. Food and Drug Administration (FDA)-approved therapy to treat primary immunodeficiency diseases (PIDDs), immune-mediated thrombocytopenia (ITP), Kawasaki disease, chronic lymphocytic leukemia (CLL), chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor neuropathy (MMN). However, getting reimbursement for the drug can be challenging even for the most experienced providers. What is required when submitting a claim may vary depending on the insurer. Accuracy in submission for authorization is imperative to ensure patients receive therapy when needed and to eliminate the potential for denial by the payer.

Conducting the Benefits Investigation

Prior to initiating IG therapy, the provider who will be administering the therapy should conduct a thorough benefits investigation for the patient. The benefits investigation will reveal whether the payer requires a patient to use a preferred provider, whether pre-authorization is necessary and whether IG therapy falls under the patient’s prescription benefit or the major medical benefit. It also will reveal the patient’s deductible under the major medical benefit and how much has been satisfied, the maximum patient responsibility and how much has been satisfied, what the plan pays (percentage) and the site-of-care (which may include the patient’s home, the physician’s office or a hospital outpatient infusion suite) and in-network options. Once the benefits investigation is complete, the provider should notify the patient of his or her options before moving forward with the therapy.

Obtaining Pre-Authorization

Years ago, pre-authorization for IG therapy was not routinely required, but today it is generally required by most commercial payers and by Medicare Part D plans. Once an authorization has been given by a payer, treatment can begin. Typically, pre-authorization is obtained by the provider based on information provided by the prescriber. It is highly recommended to check the payer’s requirements for treatment, which usually can be found online or by calling the payer, before applying for authorization.

Prior authorization and insurance coverage for IVIG vary based on the patient diagnosis, where the patient will be infused, who will be submitting claims for the infusion and by the type of payer source. There are many differences between Medicare and commercial insurance. For example, commercial insurance companies typically will reimburse for IG to treat many disease states regardless of whether they are designated as FDA-approved for IG therapy. In the physician office or hospital outpatient setting, IG is reimbursed under Medicare Part B for most diagnosis codes. In the homecare setting, Medicare Part B reimburses for only five specific primary immune deficiency diagnosis codes, which are 279.04, 279.05, 279.06, 279.12 and 279.2. However, Medicare Part D will reimburse for additional diagnosis codes in the home.

The diagnosis codes for the FDA-approved indications other than PIDD listed above are 204.10 (CLL), 287.31 (ITP) 446.1 (Kawasaki disease), 357.81 (CIDP) and 357.9 (unspecified neuropathy) for MMN. Some of the more frequently diagnosed indications that are not FDA approved for IG therapy, but that may be reimbursable include 340 (multiple sclerosis [MS]), 358.00 (myasthenia gravis [MG] without exacerbation), 358.01 (MG with exacerbation), 710.4 (polymyositis), 710.3 (dermatomyositis), 357.0 (Guillain-Barré syndrome [GBS]), 694.4 (pemphigus) and 694.5 (pemphigoid).

The need to submit the proper ICD-9 code is an important step in the authorization process. An incorrect ICD-9 code may result in a billing error and cause payment delays. The diagnosis code set currently accepted on Medicare claims is ICD-9-CM. While ICD-10-CM codes have been adopted, there is pending legislation to delay implementation of these codes until 2014. Until then, all coding claims must be submitted using an up-to-date ICD-9-CM book. ICD-9-CM codes are valid from Oct. 1 through Sept. 30 of the following year. For example, claims for date of service Oct. 21, 2012, must be coded using valid diagnosis codes from a 2013 ICD-9-CM book.

A very important element of coding is to accurately report a patient’s diagnosis, symptom or complaint codes to the highest level of specificity. The ICD-9-CM diagnosis code set includes codes with three, four and five digits. Claims using a three-digit code should be used if there are no four-digit codes within that code’s category, and four-digit codes should be used if no five-digit codes exist.¹ For example, claims submitted with ICD-9-CM diagnosis code 279 will be rejected, as more specific diagnosis codes (279.04, 279.05, etc.) are available.

In addition to ICD-9 codes, all diagnoses generally must be substantiated through clinical and diagnostic documentation. This may include office notes and/or a history and physical, lab work, procedures performed during the workup, and any medications tried and failed, not tolerated or contraindicated. Results of any prior response to IG therapy also should be provided if applicable.

The No. 1 reason for delaying an authorization is incomplete clinical information from the prescriber. Clinical information for PIDD patients should include the history of infections (type, treatment, occurrence), Ig levels (IgG and subclasses, IgM and IgA), vaccination response (failure to show a response to pneumococcal, tetanus and diphtheria vaccines) and other tests depending on the type of immune deficiency.

For neuromuscular diagnoses, results of tests such as a nerve conduction, electromyogram (EMG), muscle biopsy and spinal tap may be required. For example, for CIDP patients, documentation required to approve IG may include EMG, nerve conduction studies, cerebral spinal fluid tests and a history of the symptoms, as well as a complete neurological examination.

Prescribers and providers should be aware of payer requirements to authorize IG therapy. Every payer, whether private or government, has different guidelines for approving IG. Some are very simple, and others are very detailed. If it is determined that the diagnosis is within a payer’s guidelines and proof of that diagnosis is submitted, IG should be approved.

Billing for Reimbursement

Billing codes for reimbursement are the responsibility and liability of the provider of IG therapy, including the drug, supplies and nursing costs (if applicable). Codes should include, but are not limited to, national drug codes (NDCs), ICD-9-CM codes and Healthcare Common Procedure Coding System (HCPCS) codes. HCPCS codes are broken into two sets: level 1, which are current procedural terminology (CPT) codes, and level 2, which are J codes.

Each IG product is assigned a unique NDC code that consists of an 11-digit, 3-segment number, which identifies the labeler, product and trade package size. As mentioned previously, the ICD-9-CM codes are those assigned to the indication or disease state for which the product is being prescribed. CPT and J codes are numbers assigned to every task and service a medical practitioner may provide to a patient, including medical, surgical and diagnostic services. CPT and J codes are used by all payers (although private insurers prefer CPT codes and Medicare favors J codes) to determine the amount of reimbursement that a provider will receive by an insurer. For IG products, the following codes are used: Carimune NF (J1566), Flebogamma 5% and 10% DIF (J1572), Gammagard Liquid (J1569), Gammagard S/D (J1566), Gammaked (J1561), Gammaplex (J1557) Gamunex-C (J1561), Hizentra (J1559), Octagam (J1568) and Privigen (J1459).

Providers bill for the cost of the drug in predetermined increments. For instance, the cost of Hizentra (subcutaneous IG) is billed in 100 mg increments. Therefore, if a patient is receiving 10 grams weekly, the provider would bill for 100 units of J1559 per week. But, Gammaplex (intravenous IG) is billed in 500 mg increments. In this case, for a patient receiving 1,000 mg (equaling 1 gram), the provider would bill for 2 units of J1557. Providers also bill for the costs of supplies and nursing, if applicable. Under Medicare, supplies are billed with one of two codes: K0552: external drug infusion pump, syringe type cartridge, sterile, each or A4221: maintenance of drug infusion catheter, per week. Under private insurance, supplies are billed with S9338: immunomodulating agent — per diem.

For a Medicare patient infusing IG in the home, nursing is reimbursable if the physician certifies the patient is homebound. If a patient is homebound, nursing is 100 percent covered under Medicare Part A when the nursing is provided by a Medicare-certified home health agency. If a patient is not deemed homebound, the cost for a nurse to visit the home may be billed to the patient. For a patient with private insurance, nursing is usually covered with codes 99601: high-tech registered nurse visit (2 hours) and 99602: high-tech registered nurse visit (additional hours).

When billing, providers should be sure to include the authorization number.

How much the provider will be reimbursed for the cost of the drug, supplies and nursing depends upon the contract between the provider and the payer. Medicare sets the reimbursement rates for IG products each quarter, and they are published in each issue of this journal on the BioDashboard page (see page 65), as well as on the Centers for Medicare & Medicaid website at www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/index.html. Medicaid formularies vary by state and can be located on each state’s Medicaid site, which can be found at www.medicaid.gov. Private insurers will reimburse the cost of IG therapy based on the provider’s contract with the company.

Providers should pay close attention to deadlines for obtaining authorizations and for billing because the duration of authorization differs from payer to payer. Prior to reauthorization, the payer may require evidence of a positive response to IG, which may be documented in the form of an exam performed by the physician or by lab work.

If deadlines are met and the proper billing procedures are used, providers should be reimbursed without issues. Again, most errors are due to coding mistakes. If there is any doubt or confusion about the proper billing codes, some manufacturers have coding guides or reimbursement staff to assist (see Manufacturer Contacts for Billing Assistance).

Filing an Appeal

There is always a chance authorization may not be granted for IG. When a payer denies authorization of IG therapy, the patient and prescriber will receive a letter stating the denial and the reason. The provider often does not receive the denial letter unless the provider submits the authorization on behalf of the patient.

When a payer denies reimbursement for IG therapy, an appeal can be made. The first thing that should be checked prior to filing an appeal is whether the proper codes were submitted on the claim. If they were correct, an appeal can be made by submitting a letter of medical necessity (LMN) or requesting a peer-to-peer conversation between the prescriber and a medical director from the insurer.

The LMN should state the medical necessity of IG therapy particular to the diagnosis, as well as provide evidence-based medical data that pertain to the physician’s diagnosis. A search of medical journals will turn up studies that substantiate the effectiveness of IG therapy for a particular disease state. In addition, the LMN should indicate the failure or intolerance of other therapies. A prior response to IG therapy should be included. Instructions on how to appeal are always included in the denial letter.

In some cases, rather than a written appeal, a conversation known as a peer-to-peer may be better, especially for complex cases. In this situation, the prescribing physician and the insurance company’s medical director can discuss the justification for IG therapy. The denial letter provides instructions for requesting a peer-to-peer review.

It’s important to note that under the Affordable Care Act, there are new health insurance appeal rules that apply to health plans created or purchased after March 23, 2010.

Specifically, when a payer denies payment for a treatment or service, the patient can request an appeal, and the payer is required to review its decision. For plan years or policy years beginning on or after July 1, 2011, when the payer denies a claim, it must notify the patient of the reason the claim was denied, the patient’s right to file an internal appeal, the right to request an external review if the internal appeal is unsuccessful, and the availability of a consumer assistance program (if the state in which the patient resides has one).

When an internal appeal is filed, the payer must give a decision within 72 hours after receiving the request when appealing the denial of a claim for urgent care, within 30 days for denials of non-urgent care not yet received, or within 60 days for denials of services already received. If after an internal appeal the payer still denies the request for payment or services, the patient can ask for an independent external review by an organization that will decide whether to uphold or overturn the payer’s decision. If the external review organization overturns the payer’s denial, the payer must reimburse the claim.

The internal appeals rights under the Act take effect when the plan starts a new plan year or policy year on or after Sept. 23, 2010. The external review rights took effect Jan. 1, 2012 (although some states already have an external review process that meets the new rules).

Accuracy and Timing Are Crucial

Patients who rely on IG therapy could be placed at great risk of medical complications should they be denied coverage. With the prohibitively high cost of IG therapy, most patients are unable to afford the drug without coverage. What’s more, when an appeal is necessary, patients, physicians and infusion providers all face financial hardship with time-consuming delays in the appeals process. Therefore, accurate and thorough authorization and error-free billing practices will provide a win-win situation for all when this critical lifesaving therapy is needed.

RONALE TUCKER RHODES, MS, is the editor of BioSupply Trends Quarterly. LESLIE J. VAUGHAN, RPh, is senior vice president of clinical services at NuFACTOR Specialty Pharmacy. MICHELLE GREER, RN, is the vice president of sales at NuFACTOR Specialty Pharmacy.