Making Policy in the Dark: The Use of Activated Vitamin D Under Bundled Payments for Dialysis Care

Since dialysis therapy first became available to treat patients with end-stage renal disease (ESRD), renal osteodystrophy has been recognized as a "most troublesome" complication, leading to bone pain, proximal muscle weakness, and fractures.1 In 1986, the US Food and Drug Administration (FDA) approved calcitriol, the first intravenous form of "activated" (1,25 hydroxylated) vitamin D, for treatment of hypocalcemia and secondary hyperparathyroidism in kidney failure. In the late 1990s, the activated vitamin D analogues doxercalciferol and paricalcitol entered US markets with a hope that they would more effectively lower serum parathyroid hormone (PTH) levels with less hyperphosphatemia and hypercalcemia than calcitriol.

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