Medicare IVIG Access Act Summary
Approximately 10,000 Medicare beneficiaries living with Primary Immune Deficiency Diseases (PIDD) require medically necessary intravenous immunoglobulin (IVIG) treatment to maintain health. PIDD patients are unable to produce protective antibodies or to develop immunity to help the body fight serious infections. Whereas PIDD patients used to die in childhood or early adult life as a result of repeated infection, antibody replacement therapy in the form of regular infusions with immunoglobulin (IVIG) prepared from the plasma of normal individuals has proven to be life saving. Unfortunately, if the treatment is delayed, the patients once again become susceptible to serious infections. Recently many of these patients have had this essential treatment denied or delayed due to concerns about inadequate Medicare reimbursement.
A 2006 patient survey found that many Medicare patients have been shifted from a physician office to hospital outpatient departments for IVIG infusions. Medicare reimbursement was the primary reason for changes in location. The OIG surveyed physicians and 61% “indicated that they had sent patients to hospitals for IVIG treatment because of their inability to acquire adequate amounts of IVIG or problems with Medicare payment.” The IDF patient survey also found that substantial numbers of Medicare patients have had their treatments postponed and/or reduced in frequency because of reimbursement problems. As a result, patients suffer increased infections and more hospitalizations.
The OIG report discusses the difficulty physicians have obtaining IVIG at a price below Medicare reimbursement since they are less likely to have a GPO contract. Medicare payment methodology fails to recognize what physician offices go through to obtain product, as well as to administer it to patients.
The Medicare IVIG Access Act: (1) builds on the Average Sales Price (ASP) payment methodology and provides authority for Medicare to pay providers an additional fee to reflect their cost of furnishing IVIG; (2) secures adequate coverage of home infusion therapy for Medicare PIDD patients which must now pay out of pocket for all costs related to infusion other than the product; and (3) requires CMS to assess beneficiary access and impact on health outcomes for Medicare PIDD patients
Medicare Reimbursement of IVIG
The Medicare Modernization Act (MMA) of 2003 (P.L. 108-173) changed payment for IVIG to the average sales price (ASP+6%) for beneficiaries receiving treatment in a physician’s office or hospital outpatient department. CMS has responded to concerns about beneficiary access and provided a temporary pre-administration fee to recognize the increased costs of locating and obtaining the product. CMS lacks authority to provide an add-on payment that recognizes the costs associated with the unique characteristics of IVIG (i.e., storage requirements, transport, specialized pharmacies, training of health professionals, etc). Therefore, the Medicare IVIG Access Act seeks legislative authority directing the Secretary to review the OIG, ASPE and other surveys and to update the Medicare payment to provide appropriate reimbursement related to the furnishing of IVIG. The bill does not tell the Secretary what that rate should be; rather, it directs the Secretary to collect, within 6 months, the necessary data related to the unique characteristics of IVIG and asks that the Secretary, if appropriate, adjust the payment. There is precedent for this approach, the Medicare Modernization Act (MMA) included similar language for hemophilia clotting factor, which like IVIG, is a plasma derivative product.
Medicare Home Infusion for PIDD Patients: A Hollow Benefit
The legislation seeks to correct the Medicare home infusion benefit for beneficiaries with PIDD. When Congress established the home infusion benefit specific to PIDD, the new reimbursement method established for Medicare Part B drugs (ASP+6%) resulted in a hollow benefit for PIDD patients choosing home infusion. Medicare now covers only the cost of IVIG and none of the related professional services (e.g., nursing) or supplies (e.g., IV drip). Many providers are already having trouble acquiring IVIG at Medicare’s reimbursement rate, leaving them unable to subsidize the related costs not covered by Medicare. This is a patient population that must avoid unnecessary exposure to infection in other care settings and for many beneficiaries home infusion is a good option. However, currently, it is not an affordable option.
Finally, the bill requires CMS to contract for two beneficiary surveys over three years to measure changes in patient access to IVIG and providers, as well as changes in health outcomes. Since this patient population is directly impacted by any delays in care and changes of site of care that may expose them to unnecessary infections, Medicare should continue to monitor the care of these beneficiaries for a brief time following implementation of this Act.