Intravenous immune globulin therapy (IVIG) is a lifesaving treatment for patients with idiopathic thrombocytopenic purpura, primary immune deficiency diseases, neuropathies, myositis, myasthenia gravis, cancer, and a number of other diseases.  While this blood-derived treatment strengthens immune systems in primary immune deficient patients, certain types of autoimmune diseases, cancers and organ transplantations, as well as prevents paralysis in some autoimmune diseases and neuropathies, access to IVIG has been eliminated for many patients due to reimbursement and other access problems facing this community.  This has turned out to be an extremely complicated issue, and Congress requested the U.S.  Department of Health and Human Services’ (HHS) Office of the Inspector General (OIG) to report on why so many patients are denied access to their lifesaving therapy.  Additionally, a study has been published by HHS Assistant Secretary of Planning and Evaluation regarding all of the issues surrounding access to IVIG.  We know of at least ten fatalities that are being investigated by the Centers for Medicare and Medicaid Services (CMS) due to lack of access to IVIG or lack of continuity of care. These patients diagnosis included:  chronic inflammatory demyelinating polyneuropathy, chronic lymphocytic leukemia, common variable immune deficiency, hypogammaglobulinemia, myasthenia gravis, myositis and stiff-person’s syndrome.

The Medicare Modernization Act of 2003 changed the formula by which CMS reimburses physicians and hospitals for administering drugs from average wholesale price (AWP) to an average sales price (ASP) payment methodology, ASP + 6 percent.  In January 2005, CMS implemented the new average sales price (ASP) payment methodology (ASP + 6 percent) in the physician office setting, and in January 2006, the new methodology also was implemented in the hospital outpatient setting under Medicare Part B.  Further reductions have to the ASP formula has occurred in the hospital outpatient setting which have occurred in January 2008 to ASP + 5 percent and as of January 1, 2009 to ASP + 4%.  These revisions in methodology for payment of IVIG has lowered the payment rate in all sites of care, preventing many health care providers from purchasing IVIG because the cost exceeds the reimbursement payment from CMS.  Consequently, in 2005, many patients were transferred from their physician’s office or infusion suite to the hospital outpatient setting, often causing poor health outcomes for patients.  Since January 2006, when the reimbursement rate was reduced in hospital outpatient settings, many hospitals can no longer afford to continue treating with IVIG.  This has resulted in some patients being denied access to IVIG altogether or receiving a reduction in product or frequency of infusions.   

In May 2005, HHS’ Advisory Committee on Blood Safety and Availability recognized the "worsening crisis" of IVIG access and how this crisis places "patients' lives at risk."  The Committee recommended that Secretary Leavitt declare a public health emergency to enable CMS to "apply alternative mechanisms for determination of the reimbursement schedule of IVIG products."  At that hearing, the Committee heard from a patient named Pam who had lost access to IVIG and asked the Committee to help save her life.  She was in a wheel chair due to the paralysis that had set in due to lack of treatment.  When Pam testified, she could no longer receiver her IVIG because the physician could no longer afford to treat her and had transferred her to the local hospital.  A year after Pam testified, she died due to lack of continuity of care.  The hospital that she had been receiving her IVIG stopped offering infusions on an outpatient basis because they could no longer afford to provide the service.  Pam could only receive her IVIG if she met the criteria to be admitted as an inpatient.  She spent the last months in and out of the hospital’s intensive care unit until she died. 

An IVIG Town Hall Meeting was held on August 28, 2006 by HHS to hear from the patients and providers who have been affected by the IVIG access crisis.  The stories were devastating and it is clear that action must be taken immediately to restore access to IVIG for all patients in all sites of care.

Key Talking Points and Highlights/Statistics from Reports and Studies:
	Intravenous immune globulin is a human blood plasma derived product, which over the past 25 years has become an invaluable therapy for many autoimmune, primary immune deficiency, and neurological diseases as well as a number of other chronic conditions and illnesses. For many of these disorders, IVIG is the most effective and viable treatment available: It prevents life-threatening infections, paralysis, debilitating inflammation, pain and death.
	The U.S. Food and Drug Administration (FDA) recognizes each IVIG brand as a unique biologic. The differences in basic fractionation and the addition of various modifications for further purification, stabilization and virus inactivation/removal yield clearly different biological products. As a result, IVIG therapies are not interchangeable, with patient tolerance differing from one IVIG brand to another.
	The Medicare Modernization Act of 2003 changed Medicare’s reimbursement methodology for IVIG from average whole price (AWP) to average sales price plus 6 percent (ASP+6), effective January 1, 2005, for physicians, and January 1, 2006, for hospital outpatient departments, thereby reducing reimbursement rates paid to these providers of IVIG on behalf of Medicare beneficiaries.
	The Centers for Medicare and Medicaid Services has further reduced reimbursement for all drugs in the hospital outpatient setting which includes IVIG, as follows: January 2006 – ASP + 6%, January 2007 – ASP + 6%, January 2008 – ASP + 5%, January 2009 – ASP + 4%.
	An Office of the Inspector General April 2007 report, Intravenous Immune Globulin: Medicare Payment and Availability, found that the MMA method of Medicare reimbursement for IVIG was inadequate to cover the cost of acquiring and administering the product for many providers. During the third quarter of 2006, 44% of IVIG sales to hospitals and 41% of sales to physicians by the three largest distributors occurred at prices above Medicare reimbursement.
	The report of the Office of the Assistant Secretary for Planning and Evaluation (ASPE), Department of Health and Human Services, Analysis of Supply, Distribution, Demand, and Access Issues Associated with Immune Globulin Intravenous (IGIV), issued in May 2007 notes that after the new reimbursement rules for physicians was instituted in 2005, 42% of Medicare beneficiaries who had received their IVIG treatment in their physician’s office at the end of 2004 were shifted to the hospital outpatient setting by the beginning of 2006. This shift in site of care has resulted in a lack of continuity of care and adverse effects on health outcomes and quality of life.
	The OIG also reported that 61% of responding physicians indicated that they had sent patients to hospitals for IVIG treatment, largely because of their inability to purchase IVIG at prices below the Medicare payment amounts. In addition, OIG found that some physicians had stopped providing IVIG to Medicare beneficiaries’ altogether.
	The OIG’s 2007 report concluded that whatever improvement some providers saw in the relationship between Medicare reimbursement for IVIG and prices paid during the first three quarters of 2006 would be eroded if manufacturers were to increase prices for IVIG in the future.
	An independent survey of hospital pharmacy directors showed that 32 percent of hospitals reported turning away patients for IVIG treatment at some point during 2006. (Source: Immune Deficiency Foundation)
	In recognition of dislocations experienced by patients and providers in obtaining IVIG since implementation of the MMA reimbursement methodology, CMS provided a temporary additional payment for IVIG pre-administration-related services in 2006 and 2007. The pre-administration fee was intended to compensate physicians and hospital outpatient departments for the extra resources they have had to expend in locating and obtaining appropriate IVIG products and in scheduling patient infusions. In 2008, CMS extended the pre-administration fee at the same rate for the physicians’ offices but reduced the hospital outpatient setting by approximately 50%. In 2009, CMS has eliminated the pre-administration fee.