Debating Organ Procurement Policy Without Illusions
Benjamin Hippen, MD American Journal of Kidney Diseases
"For poor patients, the primary payor for dialysis is Medicare, Medicaid, or some hybrid, unless they are ineligible for these programs. The profit margins of dialysis facilities with an average payor mix of Medicare, Medicaid, and commercial insurance is 3% to 4%.12 Crucially, a facility composed entirely of patients with Medicare and/or Medicaid as the primary payor is financially unsustainable because payments to facilities on a per-treatment basis are, depending on local labor and other overhead costs to the facility, frequently less than the cost to the facility to provide the treatment. Although a dialysis facility requires a minimum number of patients to cover labor and operational overhead costs, the total net margin of a typical facility is achieved through cross-subsidization from collections from commercially insured patients."
"A staple of opponents of financial incentives is that incentive proposals would not even bear consideration if transplantation professionals would just stop wasting perfectly good kidneys. Citing a 19% rate of organ discard in the United States, the authors argue that if only we biopsied more kidneys before turndown, made more use of organs with a Kidney Donor Profile Index > 85% (previously known as expanded criteria donors), and increased use rates of organ donation after circulatory death just like many European centers, we would be a long way toward solving the problem.
These arguments betray a lack of understanding of the extant regulatory burdens and financial constraints on US transplantation centers. In the United States, the expected risk-adjusted rate of death-uncensored transplant survival for a deceased donor kidney at 1 year is 96% (14; Fig 6.2), and 1-year expected patient survival is 98% to 99%. These outcomes represent the expectations of transplantation centers by CMS regulators, and failure to achieve these outcomes invites intense regulatory scrutiny under threat of involuntary closure.15 In the last several years, nearly 100 transplantation programs in the United States have gone through expensive stressful “mitigating factors” applications with CMS to avoid involuntary closure because of reported outcomes that were below risk-adjusted expected outcomes, although the data and veracity of the methodology used to calculate risk adjustment has been heavily criticized.16 With some frequency, scrutinized centers are required to enter into a Systems Improvement Agreement, essentially a contract with CMS to put oversight of the transplantation program into a multiyear third-party receivership, at extravagant expense to the transplantation center, until reported outcomes improve.
Regulatory scrutiny of programs that fall below expected outcomes is typically accompanied by denial of Center of Excellence status by CMS. Loss of this designation often causes commercial insurers to cancel insurance contracts and direct referrals to other programs. This is a profound incentive to embrace risk aversion.16 and 17 Refashioning insurance agreements and changing ingrained referral patterns is a slow process and can pose significant medium-term challenges to the financial stability of a transplantation program long after the quality issues have been resolved to a regulator’s satisfaction."