FFF Enterprises has the responsibility of distributing approximately one-third of the nation’s IVIG supply. As the nation’s largest distributor of IVIG, publishers of IG Living, an award-winning magazine for patients who rely on IVIG and their providers, and operator of NuFACTOR, a specialty pharmacy infusion service for patients who require IVIG treatment, we have a unique vantage point.

From our view, we see an ongoing patient healthcare crisis.

Beginning in January of 2005, with the implementation of the Medicare Modernization Act, patients across the country began to have issues related to access to this lifesaving therapy. If you were a Medicare patient who customarily received IVIG infusions in a physician office, you were likely told that the doctor’s office could no longer afford to provide the therapy and you would need to find treatment elsewhere. Implementation of the MMA reduced the payment from approximately $81 per gram to, in some cases, less than $50.

This forced patients to migrate to another healthcare setting, hospital outpatient departments — the most expensive healthcare settings in America. And, if you are a primary immune deficient patient, someone whose body does not produce adequate antibodies to protect them, the hospital is unquestionably the worst place to be. According to recent data from the Centers for Medicare and Medicaid Services (CMS), approximately 40% of Medicare patients were shifted from the physicians’ offices to the hospital outpatient setting during 2005.

This scenario, however, was temporary because the phased-in implementation of the MMA impacted hospitals next. This began in 2006, and many hospitals have discontinued IVIG infusion therapy or have been unable to accommodate new patients.

This problem has persisted for more than two years. Industry has done much, working together to help solve these problems. Manufacturers have increased production of this vital protein and are now collecting more plasma and producing more IVIG than ever before.

But demand for this miracle product is robust and growing. Nearly all manufacturers have consolidated their distribution channels, increasing access to IVIG and limiting price gouging and criminal drug diversion. Although much work remains to be done, manufacturers’ careful selection of distribution partners and greater oversight on business practices have improved access and reduced price volatility.

Progress is being made on nearly every front except on the MMA ASP reimbursement formula.

The HHS Assistant Secretary for Planning and Evaluation (ASPE) held an IVIG Town Hall Meeting in September 2006. The Secretary’s office commissioned a study that has been completed, but has not been released. Likewise, the HHS Office of the Inspector General (OIG) has been conducting a study requested by the U.S. House of Representatives Energy and Commerce and Ways and Means Committees. The first two phases of the study have been completed, and we all — especially patients — eagerly await the results. The reports are long overdue, and we are not aware of any reported reason that either study’s results have not yet been made public.

The Secretary of Health and Human Services, Advisory Committee on Blood Safety and Availability has recommended on two occasions that the Secretary declare a public health emergency in order to give CMS the authority to use an alternate formula, to increase reimbursement to IVIG and restore access to Medicare beneficiaries.

Many letters have been sent to the Secretary, including a recent letter sponsored by Congressional Representatives McCrery (R-LA) and Israel (D-NY) , signed by 58 Members of Congress. The letter requested the Secretary implement his own Advisory Committee’s recommendations and declare a public health emergency or use any other means to restore access to IVIG. Still, no action has been taken.

The cost of this inaction on the well-being of patients who are already disabled or elderly is immeasurable. Further delays would be grossly irresponsible.

Please ask your elected representatives to urge the Secretary to take action today. To write to your reps, visit http://www.igliving.com/action_alert.html. The patients need your help and they deserve it.