Immune Globulin Reimbursement

By Kris McFalls and Trudie Mitschang

Immune globulin (IG) is a life-enhancing and life-sustaining product for tens of thousands of chronically ill patients in the U.S. It contains antibodies that protect individuals from a broad spectrum of bacteria and viruses, and it is prescribed primarily to treat three categories of illness: primary immunodeficiencies, autoimmune neuromuscular disorders and certain rheumatological conditions. Although IG is most commonly delivered through a needle placed into the vein, known as intravenous IG (IVIG), some IG products also can be administered under the skin, known as subcutaneous IG (SCIG).

Because IG is an especially high-cost drug therapy, the issue of reimbursement for IG treatment is always front-of-mind for patients and their prescribing physicians. One of the reasons IG is so costly is that its manufacturing process tends to be both lengthy and complex. Immune globulin is made from pooled plasma taken from literally thousands of donors. Its procurement, testing and fractionation protocols designed to produce a product that is safe and contaminant-free, coupled with current reimbursement models, create the perfect storm in terms of access and cost issues. A closer look reveals that some reimbursement policies, including prior authorizations, failfirst requirements and specialty tiers, can create barriers to care.

Prior Authorizations Are Not Universal

Doctors who prescribe IG for their patients are keenly aware of reimbursement issues that commonly arise. Likewise, payers are attentive to the high cost and growing number of indications, both on and off label, for which IG is used. Over time, most if not all payers have developed medical policies regulating coverage for the use of IG. Frequently, problems and confusion arise because coverage criteria and forms for accessing care are unique to the payer, rather than being standardized for the physicians who must comply with them. Additionally, reasons for denial are often very generic and, in general, do not clearly detail what is needed to access care.

For such an expensive treatment as IG, most payers utilize medical management and require a preauthorization request be submitted before therapy can begin. Payers are happy to provide preauthorization forms to fill out, but those forms are not always accompanied with the medical policies that physicians must follow to attain authorizations, making this process especially confusing and time-consuming for physicians and their office staff. “I have the equivalent of one full-time [employee] just dedicated to IVIG approvals,” says Todd Levine, MD, clinical assistant professor, University of Arizona, and co-director of Samaritan Neuropathy Center, Phoenix Neurological Associates. “In addition, the review process tends to be arbitrary. With the same insurance company, there can be very different decisions with no clear reasoning. It takes a lot of my time to educate medical directors to make them understand why I am prescribing IVIG.”

Currently, prior authorization requests must be submitted with a letter of justification, office notes and lab reports substantiating the diagnosis and a treatment plan. In addition, reauthorization requests must show office notes detailing the progress made and, if applicable, indicate attempts have been made to reduce the dose or increase the interval between treatments.

Further complicating the paper trail, payer denials tend to be generic statements that do not fully explain the denial. Reasons most commonly given for denial are that the prescribed treatments are investigational, experimental or not medically necessary. These denial terms usually mean one of two things: 1) the reason for treatment in the authorization is not eligible for coverage under the insured’s plan, or 2) the payer was not given enough information to substantiate the authorization request.

“The approval process could be streamlined by finding a way to let experts take more control of the field, make decisions more transparent, or by forming better relationships between experts and insurance companies in designing criteria and making decisions,” says Jon Katz, MD, director, Neuromuscular Clinic, Forbes Norris Center, San Francisco, Calif.

Experimental or Investigational

Figuring out upfront what treatments a payer covers used to be mostly guesswork. Thankfully, most payers now clearly list online the diagnoses they will and will not pay for. If the diagnosis is not covered, the reason for denial of authorization will most likely be given as experimental or investigational. Providers confronted with an authorization request deemed experimental or investigational should double-check their request for clerical mistakes.If an incorrect or ambiguous code such as “immune deficiency not otherwise specified” was used on the authorization request, it can be quickly corrected.

On the other hand, if the code is correct and the plan simply does not cover the diagnosis, further research may help reverse the coverage decision. To strengthen an appeal, it is important to include peer-reviewed materials that support the recommended treatment.

Not Medically Necessary

Even if an authorization request is for an indication that is FDA approved, or considered off label but a proven use, it still can be denied as not medically necessary. Unfortunately, such a generic term does not provide the patient or the physician with the details needed to effectively craft an appeal.

The term “not medically necessary” generally means the information submitted is incomplete, does not meet all the diagnostic criteria listed in the policy, and/or the patient has not yet failed other treatments that are considered the leastcostly alternative. While some payers are beginning to give more written detailed information regarding denials, many still do not. 1 “In my opinion, payers should have to explain the reason for denial in medical language,” says Katz. “Form letters are not reasonable; the denial should prompt a transparent peer review.”

Payers routinely require physicians to provide documentation demonstrating that a particular diagnosis is accurate and/or the treatment requested is medically necessary. Payers also are clear that office notes or letters detailing the condition without supporting test results do not constitute medical necessity. Consider, for example, an authorization for a patient diagnosed with multifocal motor neuropathy (MMN) that includes a doctor’s note that reiterates abnormal electrodiagnostic studies and high-titer serum IgM anti-GM1 antibody levels, but does not include copies of the reports for all findings in the authorization request. The result is the payer denies the request as not medically necessary, but fails to inform the doctor that the missing testresultswere the basisforthe denial.The doctor is then left spending more valuable (and unreimbursable) time first trying to figure out why the authorization was denied and then providing the missing documentation in an appeal. Meanwhile, the patient’s treatment is delayed, perhaps limiting the chances for a good recovery.

As another example, Medicare recently changed its policy regarding SCIG to only reimburse claims in which the provider has used the Freedom 60 infusion pump. If a provider bills for any other pump, the entire claim will be denied as medically unnecessary because the least-costly infusion pump was not used. Illogically, even though the treatment was medically necessary, the entire claim is rejected as not medically necessary.²

Fail-First Policy

Payers also often insist on step therapy or fail-first policies for certain diagnoses before IG will be authorized. This is especially common for off-label indications. As an example, a failfirst policy might come into play with the indication of dermatomyositis. Most payer policies require patients with this disorder to first fail corticosteroid therapy before IG therapy is approved. Failure can be due to a patient being either refractory to corticosteroids or to corticosteroids causing detrimental side effects. In either case, the use of IG becomes a second line of therapy. Disregarding fail-first policies also will result in denials citing reasons of medical necessity.

When appealing a denial based on medical necessity, physicians and/or patients should first request a copy of the medical policy detailing what parameters the payer uses to determine diagnostic criteria; if there is a fail-first policy; and what, if any formulary there is regarding choice of product. Often, the quickest way to get specific information is for the treating physician to speak directly with the payer’s medical director. While on the phone, it is likely that the treating physician will be offered a chance to appeal without resubmitting documentation or to submit only the missing documentation. This approach may appear to expedite resolution, but to avoid a second denial, it is advisable to resubmit the entire file with an appeal, while also supplying any missing documentation and any compelling reasons why the appeal should be considered. Keeping detailed notes of conversations with medical directors and others assigned to the claim is also suggested.

Specialty Tiers

The recent introduction of specialty tiers that increase the beneficiary’s share of the costs has had detrimental effects on IG patient outcomes. Specialty tiers require the patient pay a certain percentage of the cost of their medication ratherthan a fixed copayment and often do not have a maximum out-of-pocket limit. The out-of-pocket expenses are becoming prohibitive.

Specialty tiers coupled with lower reimbursement rates and falling profit margins force healthcare providers into a particularly precarious position. Doctors treating immune-mediated diseases with IG have few if any other treatment options.At the same time, healthcare providers simply cannot absorb all of the risk plus the extra costs and still stay in business. For these reasons, some providers support legislation that will mitigate the out-of-pocket liabilities to patients. “The concern [about] specialty tiers is [that] it [is] shifting more of the financial burden onto patients,” says Dr. Levine. “I have many patients who cannot get IVIG because of their high deductible. Specialty tiers will only make this worse, and more and more patients won’t get the best therapy available simply based on cost.”

Dr. Katz agrees: “It seems ridiculous to put this on patients. The drug is so expensive that the insurers and doctors should be the ones who ensure that therapy isrational.The goal isto create appropriate checks and balances. The patients need to understand that the issues here are not black and white, but they should not have to pay large amounts for appropriate ordering.”

A Crisis of Care

In 2003, the Medicare Modernization Act altered the formula by which the Centers for Medicare and Medicaid Services (CMS) reimburses physicians and hospitals for administering drugs from an average wholesale price (AWP) model to one based an average sales price (ASP). While this ASP model was originally intended to apply to Medicare reimbursement, it has since expanded to include the physician office setting and the hospital outpatient setting under Medicare Part B. How has this impacted IVIG therapy? A lowered payment rate in all sites of care is preventing many providers from purchasing IVIG since the costs exceed reimbursement payments. This conflict is causing what some are calling an “IVIG crisis,” with many patients being denied access to IVIG or receiving a reduction in product or frequency of treatment. Depending on the diagnosis, this crisis could put patients’ lives at risk.³

A Complex Problem with No Easy Solutions

The diseases treated by IG are rare and often misunderstood. As a complicating factor, the reimbursement issues surrounding this miraculous treatment are often complex and equally misunderstood. What is clear is that a cookie-cutter approach to reimbursement does not serve the interests of the patient or the provider.

While there is no quick fix, it seems evident that all stakeholders, including payers, providers and patient advocacy groups, will need to work together to identify solutions that will ultimately prioritize patient health and welfare and put prescribing physicians back in the driver’s seat when it comes to treatment recommendations. “The best process would be to have one universally accepted criteria for who will and will not get IG therapy,” suggests Dr. Levine. “In a perfect world, there also should be a standard process for reauthorization once a patient has been on IG therapy for three to six months. This would help prescribing physicians maintain continuity of care and avoid putting patients at risk.”

KRIS MCFALLS and TRUDIE MITSCHANG are staff writers for BioSupply Trends Quarterly magazine. Kris also is the patient advocate for IG Living magazine