Director of Hospital and Ambulatory Services
Centers for Medicare & Medicaid Services
RE: Calendar Year for New Clinical Laboratory Tests Payment Determinations
In Support of Cylex Request for Reconsideration of Crosswalk Decision for CPT Code 86352
From my testimony at the July 22, 2010 Public Meeting
Good morning, my name is Donna Cryer. Today is my 40th birthday. Transplantation works. 16 years ago I was the beneficiary of a very skillful surgical intervention. But I stand here today because of a complex regimen of immunosuppressive medications. I may not be able to stand here 16 years from today if appropriate reimbursement is not given to Cylex’s Immuknow.
Allow me to explain . . .
After graduating from Harvard and between my 1st and 2nd year of law school at Georgetown my body finally succumbed to more than a decade of autoimmune disease and I waited in intensive care for an organ I was eventually blessed to receive. Subsequently I served on staff as a patient affairs specialist at the united network for organ sharing and was invited back as a volunteer on the membership and professional standards committee. Currently I am a member of the board of directors of the American liver foundation and a patient representative to the U.S. Food and Drug Administration. I use Immuknow with my transplant team to manage my care.
I am here today representing myself and speaking in support of Cylex’s request for reconsideration.
I am here to remind us that what we discuss and decide here today are not abstract or academic issues but are life and death to patients like myself who rely on immunomodulation therapies and who rely on third party payors like Medicare & Medicaid to enable our access to approved and validated care.
My remarks will focus on the impact of inadequate reimbursement on patients in three areas: access, cost, and quality.
Inadequate reimbursement of immuknow may prove to be an absolute bar to patient access. Medicare, particularly through ESRD, covers such a large proportion of transplant recipients that hospitals simply will not be able to take on the burden of covering the loss for performing each test and patients will lose out on a unique and necessary tool for managing our complex immunosuppressive regimens.
No other current clinical decision support tool provides for early, actionable information so a clinician can intervene to prevent rejection not just deal with complications.
A personal example: my creatinine has been rising, indicating that the immunosuppressants may be having a nephrotoxic effect. The initial reaction from my physician was to lower my dosage, but because we also did an Immunknow test we saw that my immune system is highly reactive and we risked rejection if we reduced the dosage. We are working on other therapies to reduce the impact on my kidneys. Because I had access to this test, we were able to avert the need for rescue therapy, hospitalization, and possible graft loss.
No other current clinical decision support tool allows personalized treatment, so that an individual’s immune system is balanced with graft survival, risk of infection and long-term consequences.
My doctors did a great job of saving my life and my organ but because we did not have this tool early enough my creatinine is rising, I have osteoporosis and osteonecrosis from too much prednisone, and, these high heels notwithstanding, my orthopedist has told me I’ll need knee replacements. We can do better now. Let’s do better now.
According to a National Kidney Foundation analysis Medicare will pay on avg. $100k for the 1st year of transplant or retransplant, my 1st year costs were well upwards of $300,000 – to not pay the approximately $600 for a test that can avoid the need for retransplantation seems unwise to say the least.
Let’s be clear, current practice is to use gestalt, accompanied by proxies such as levels of Immunosuppression medication in the blood, enzymes, or if we’ve waited too late, biopsies to diagnose rejection.
Medicare spends an average of $17k per year/per recipient for medication after the 1st year. (which is 80% of costs under part b if transplant is eligible under Medicare) (NKF data)
Because Immunknow use allows for personalized therapy, patients have greater confidence in the treatment plan which promotes greater compliance thereby reducing adherence-related rejection and costs.
Immunknow use in some cases results in lower costs from reduced prescription expenditures or hospital admissions.
Finally, as a patient it is extremely difficult to trust the U.S. healthcare regulatory system or have confidence in emerging therapies if one agency will not support financially what another agency has defined as the precise method of performing a test to be clinically effective and valid. That is not high quality care; that is not evidence- based medicine. Inadequate reimbursement of Immuknow does not serve patients, the practice of medicine, or the healthcare system. It removes a critical tool for managing transplant recipients and loses sight of the scale and scope of other costs related to ESRD and transplantation in the absence of this assay.
I support Cylex’s request and ask that CMS please grant this request for reconsideration of the crosswalk decision for CPT Code 86352.
Thank you very much.
Disclosure note: I am a consultant to Cylex ( I asked to work with them because I believe in this test), but not paid for this testimony.