By Bill Peckham
Before MIPPA was passed, when bundling was talked about as a concept, one of the benefits of an expanded bundle was imagined to be that people using home hemodialysis (HHD) would be able to self administer neccessary injectable drugs, besides EPO:
[INDENT]One point always offered in defense of expanding the bundle is that it will increase the dialysis provider’s flexibility in providing care … I currently have to go incenter to receive iron and I cannot receive IV activated vitamin D at home only due to reimbursement rules. Under a bundle I assume that I would be able to avoid the trip incenter to get iron. Whether I would receive IV Active Vitamin D (calcitrol - Rocaltrol (Roche), Zemplar (Abbott)) or continue to receive Active Vitamin D in pill form [/INDENT]
would now be up to my physician. Post bundle, reimbursement would be neutral as to the form of my activated vitamin D. Or so I thought.
On page 150-151 of CMS-1418-F 151 the ESRD PPS (900+ page PDF) there is this comment and response (my emphasis):
[INDENT]Comment: Some commenters suggested that CMS allow for self-administration of injectable ESRD-related drugs at home by home dialysis patients. The commenters indicated that home dialysis patients would prefer to self-administer all injectable ESRD-related drugs at home to include EPO, rather than traveling to the dialysis facility to receive the injectable drugs. The commenters reasoned that since injectable drugs such as EPO, Vitamin D, and IV iron are included in the ESRD PPS bundle, patients should have the option to self-administer these drugs at home.
Response: Under section 1861(s)(2)(O) of the Act, selfadministration of erythropoietin (EPO)is permitted for dialysis patients who are competent to use such drug without medical or other supervision with regard to the administration of such drug. If a dialysis patient meets this requirement, then he or she can self-administer erythropoietin at home. Payment for erythropoietin and supplies needed to self-administer the drug would be included in the ESRD PPS payment. The ESRD PPS does not fundamentally alter how other injectable drugs are administered under Part B. Thus, under CMS-1418-F 151 the ESRD PPS, home dialysis patients would continue to go to the dialysis facility for the administration of other injectable drugs.[/INDENT]
I’ve always assumed that the rule limiting HHD reimbursement, and thereby access, to injectable Vitamin D and iron was an inadvertent quirk of the payment system. I’ve always assumed it was just something that came with doing home dialysis in an incenter dialysis world. This response suggests otherwise. This response suggests that CMS was purposeful in excluding those using HHD under the previous reimbursement rules and plans to continue the practice.
I can’t think of a reason for CMS to take this position. I would think that under the expanded bundle this practice of medicine - which drug, in what form, where it is administered, by whom - should be left up to the provider working with nephrologists. It may be that providers and docs will decide that iron should be administered during clinic visits or that an oral version of vitamin D is best, but why is CMS taking a position?