Science and technology have come a long way in changing the landscape of preventive and curative medicine. Vaccines, antibiotics, biologics and other therapies have saved and transformed countless lives.
Primary immunodeficiency diseases (PI) represent a group of more than 250 related, rare genetic diseases. The defining characteristic of these conditions is that the immune system is malfunctioning or non-existent, resulting in a decreased ability to fight off infection.


For those living with PI, many require lifelong treatment with immunoglobulin (Ig) replacement therapy to replace missing or improperly functioning antibodies needed to fight infection. Ig replacement therapy for patients with PI is complex and requires oversight by a provider familiar with the patient’s specific condition. It is the sole therapy for antibody deficient patients.
Unfortunately, access to this life-saving therapy could be threatened as a result of an experimental initiative recently announced by the Centers for Medicare & Medicaid Services (CMS). This plan focuses on cost savings rather than on ensuring access to treatments that offer patients the best quality of care.
Patients with PI are not ‘crying wolf.’  In the past, the PI community experienced serious disruption in access to care resulting from Medicare reimbursement changes.  When the Medicare Modernization Act of 2003 (MMA) altered Part B drug reimbursement from average wholesale price (AWP) to average sales price (ASP), patients had difficulty finding physicians who could afford to infuse them with intravenous immunoglobulin (IVIG).  In fact, the Health and Human Services Office of Inspector General reported to Congress that, “Sixty-one percent of responding physicians 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.[i]”
And, while the MMA allowed a benefit for patients with PI to have IVIG infusions at home, the reduction in Medicare reimbursement was so low as to render the benefit useless and hollow.  In fact, it took an act of Congress in 2012 to authorize a temporary “fix” to the problem until a permanent one is in place.
The purpose of the proposed project is to reduce “Medicare expenditures, while preserving or enhancing the quality of care provided to Medicare beneficiaries.” CMS assumes and believes that the current reimbursement rate motivates providers to prescribe more expensive rather than less expensive drugs. CMS’ solution is to slash reimbursement to providers of Part B drugs, a measure that I am concerned will hurt quality care.
While CMS’ intent is to save money, the results of this demonstration stand to severely impact patients who rely on Medicare. The reduction in reimbursement will force many providers to stop offering the most clinically effective treatments, leaving patients with two options: forego prescribed therapies or travel to more expensive settings to receive treatment and absorb the associated increased costs.
Perhaps more concerning is that when developing this new payment model, CMS made no effort to hear from patients or physicians - the two groups primarily impacted. I, and the patients and physicians of the PI community, strongly oppose any effort to rush through a regulatory initiative that may adversely impact patients’ access to life-saving and life-enhancing Medicare Part B covered therapies.
It is my sincere hope that CMS will reflect on the proposed payment experiment and seriously consider patient outcomes and what is truly best for patients. I respectfully urge lawmakers in Congress to warn CMS against this dangerous experiment on Medicare recipients.  It may prove to be detrimental to their constituents living with primary immunodeficiency diseases and countless other chronic diseases.

Boyle is President and Founder of the Immune Deficiency Foundation.