Reimbursement FAQs: SCIG and Vaccines

Historically, home infusion of subcutaneous immune globulin (SCIG) has been reimbursed by Medicare Part B using the 95 percent of average wholesale price (AWP) methodology. Now that Gamunex-C has an SCIG indication for primary immunodeficiency, will it be covered at the same rate?

Previously approved SCIG products such as Hizentra and Vivaglobin produced by CSL Behring have been reimbursed at 95 percent of AWP using the durable medical equipment (DME) benefit. Gamunex-C should fall under the same formula. However, Gamunex-C presents a unique challenge not previously faced by the Centers for Medicare and Medicaid Services (CMS) when considering immune globulin (IG) products. This is because Gamunex-C has multiple indications and two routes of administration approved by the U.S. Food and Drug Administration. Therefore, the J code of J1561 used for Gamunex-C administered subcutaneously is the same J code used for intravenous (IV) administration of Gamunex-C. As a result, it has taken patience and cooperation to get properly reimbursed.

To explain coverage of Gamunex-C administered subcutaneously, CMS states:

“Payment for drugs infused through DME at 95 percent of AWP is supported by the Social Security Act, Section 1842(o)(1)(D). Furthermore, the Medicare Claims Processing Manual, Publication 100-04, Chapter 17, Section 20.1.3, states that the payment allowance limits for infusion drugs furnished through a covered item of durable medical equipment on or after January 1, 2005, will continue to be 95 percent of the AWP reflected in the published compendia as of October 1, 2003, unless the drug is compounded or the drug is furnished incident to a professional service.The payment allowance limits for infusion drugs furnished through a covered item of durable medical equipment that were not listed in the published compendia as of October 1, 2003 (for example, new drugs) are 95 percent of the first published AWP unless the drug is compounded or the drug is furnished incident to a professional service.”

In response to questions about billing for Gamunex-C for subcutaneous administration, George Oliver, senior director of managed care at Talecris Biotherapeutics, emphasizes the importance of making sure all necessary codes are used when billing CMS. Because Gamunex-C is now approved for new indications, it also has new national drug codes. Therefore, when using GamunexC subcutaneously, providers must add a J code modifier. The J code for GamunexC administered subcutaneously is J1561- JB. Oliver also cautions that when billing Medicare, it is important to remember that patients must use and providers must bill only for the Freedom 60 pump. Using and/or billing for any other pump will result in a denial of the entire claim. Providers can download a guide to coverage and reimbursement for Gamunex-C at www.gamunex-c.com/media/GamunexC_Reimbursement_Guide_GX24-0211.pdf.

Recently, it also was discovered by Karen Schaeck, reimbursement manager at NuFACTOR, the specialty pharmacy division of FFF Enterprises, that while CMS is reimbursing Gamunex-C at 95 percent of AWP, it is doing so at rates from the published compendia as of Oct. 1, 2003. However, since Gamunex-C is a new product with new indications and new NDC numbers, there is some question about whether the reimbursement rates should be based on the 2003 published rates or the first Redbook publication of AWP that was issued in December 2010. In a step toward correcting the uncertainty, CMS took comments on this issue, as well as others, in a public meeting held May 17. Specific items that were on the agenda and their descriptions that may be of interest to readers of this publication include:

Agenda item 1: Request to establish a code for prestorage pooled, leukocyte reduced, ABO-matched, bacteria tested platelets.

Agenda item 2: Request to establish a new Healthcare Common Procedure Coding System (HCPCS) Level II code for Gammaplex Immune Globulin Intravenous (Human).

Agenda item 3: Request to revise the description of existing HCPCS code J1561 “Injection, Immune Globulin, (Gamunex), Intravenous, NonLyophilized (e.g., Liquid), 500 mg” to expand its use for subcutaneous administration and incorporate trade name change from Gamunex to Gamunex-C.

Agenda item 4: Request to establish a separate code for immune globulin (human), trade name: Flebogamma 10% DIF.

Agenda item 6: Request to establish a code for belimumab, trade name: Benlysta.

Agenda item 7: Request to establish a code for alpha1-proteinase inhibitor, trade name: Glassia.

Agenda item 8: Request to discontinue existing code J7184 “Injection, Von Willebrand Factor Complex (Human), Wilate, per 100 IU VWF:RCO” and replace it with a new code for the same product, specifying a different dose descriptor.

Agenda item 9: Request to establish a code for factor XIII concentrate (human), trade name: Corifact, Factor XIII Concentrate (Human).

Agenda item 17: Request to establish a code for sipuleucel-T, trade name: Provenge.

To view summaries of this meeting, go to www.cms.gov/MedHCPCSGenInfo/08_HCPCSPublicMeetings.asp.

Under the new Affordable Care Act, are private payers required to cover the full cost of vaccines?

While the research is clear that vaccines are the single most cost-effective way to prevent disease, the cost of vaccines still prevents a large percentage of the population from being vaccinated. Historically, many private payers have covered the cost of vaccines recommended by the U.S. Preventive Services Task Force (USPSTF). However, many private insurers also required a copayment or that a deductible be met, and they required vaccines to be administered only in a doctor’s office.

But, the new Affordable Care Act requires preventive services such as USPSTF-recommended vaccines to be covered 100 percent with no copayment.This requirement applies to all plans except those that are grandfathered. So, theoretically, more Americans should have access to vaccines because the cost barrier is removed.Yet, how this program will work is in the details of the payers’ policies.

A vaccine on the USPSTFrecommended list will be 100 percent covered in a doctor’s office. But, whether there is a copayment for that visit will depend on the reason for the visit. If the reason for the visit is preventive care, such as a wellness visit, there should be no copayment. If the visit is for any other reason, the vaccines itself should be covered, but there still may be a copayment, as well as an administration charge for the vaccine.

Payers also have a preferred network for certain services, and in the case of vaccines, patients may not be able to use retail pharmacies to obtain them. Patients wanting to use a retail pharmacy should check with their insurer first to determine if the vaccines will be covered.

To view a list of vaccines covered under the Affordable Care Act, go to www.healthcare.gov/law/about/provisions/services/lists.html.