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Home hemodialysis (HHD) is the least utilized dialytic modality in the United States, behind both in-center hemodialysis (HD) and peritoneal dialysis (PD). Nevertheless, since the end of 2002, when there were only 1519 HHD patients in the United States, the size of the HHD patient population has more than quintupled.1 Policy considerations have played an important role in the expansion of HHD, with some policies encouraging growth and other policies discouraging growth.
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Much of the delivery of HHD is governed by the Medicare Survey and Certification Program, which specifies safety and quality standards, otherwise known as Conditions for Coverage (CfC). Regarding dialysis in the home setting, these standards address the requirements of HHD training, the frequency of HHD patient monitoring, and the breadth of support services, including home visits and water quality assessments. These standards were revised in 2008. At the same time, the Centers for Medicare & Medicaid Services (CMS) also issued interpretive guidance that describes for state surveyors the implications of each standard. Because the standards do require interpretation, states may ultimately permit or deny specific provider practices pertaining to HHD delivery.
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In addition to regulation by CMS and state departments of health, the US Food and Drug Administration (FDA) must evaluate HHD equipment and supplies. In practice, dialysis machines are evaluated initially in the facility setting, with emphasis on successful completion of treatments and delivery of minimally adequate small-solute clearance (e.g., as quantified by single-pool or standardized Kt/V). After a machine is cleared for use in the facility setting, the manufacturer may initiate an investigational device exemption (IDE) trial—typically employing a crossover design—that evaluates whether the machine delivers either equivalent or non-inferior treatment in the home setting. The evaluation of an IDE trial forms the basis of FDA clearance for use in the home setting. This clearance includes specific product-labeling instructions that may create limitations on use of the machine in the home setting. For this reason, additional trials may be necessary to evaluate whether a machine is cleared for nocturnal HHD or HHD without a care partner, as examples. Without additional clearances, specific applications of the machine are considered “off label,” thus creating potential liabilities that may lead healthcare providers to draft internal policies that prohibit or discourage those applications.
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Arguably, the most important part of policy concerning HHD is payment. Because most dialysis patients carry either Medicare Parts A and B (i.e., fee-for-service) coverage or Medicare Part C (i.e., Medicare Advantage) coverage, the payment policies promulgated by CMS can have a tremendous impact on the economics of HHD.
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For all patients newly diagnosed with end-stage kidney disease (ESKD), CMS requires submission of form CMS-2728, the “End Stage Renal Disease Medical Evidence Report: Medicare Entitlement and/or Patient Registration.” Usually, Medicare entitlement begins on the first day of ...