Under the bundle why can't home dialyzors self administer iron and Vitamin D?

Cross posted from DSEN

Under the bundle why can’t home dialyzors self administer iron and Vitamin D?

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]

Really?

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?

There have been sensitivity and allergic reactions to IV iron causing the patient to stop breathing and even to die. Because of this risk, the FDA requires the companies making IV iron products to have a warning on their label alerting providers to this risk and recommending that patients get IV iron in provider’s office or clinic. Some patients have been self-administering IV iron, probably because the provider either didn’t pay attention to the warning or because he/she accepted the liability due to believing the risk is low of having the patient experience a potentially life-threatening problem related to a sensitivity/allergy to the IV iron product. My sense is that most providers would prefer not to take that risk.

So far as Vitamin D analogs, until Medicare Part D came along, Medicare didn’t pay for many drugs that people took at home. The exceptions for ESRD patients were immunosuppressants and EPO. You may want to read Section 50 in the Medicare Benefit Policy Manual, Chapter 15: Covered Medical and Other Health Services, which includes the Medicare policy that states “Medicare Part B does generally not cover drugs that can be self-administered, such as those in pill form, or are used for self-injection.” It also says that Medicare B will pay for drugs “incident to” a physician (provided by the physician or his/her employee) if they’re not “usually” self-administered and defines what “usually” means. This may also be why most dialysis clinics require patients to come to clinic to get IV iron. NOTE: The “usually” not self-administered distinction might work if all CMS was looking at was IV Vitamin D (and IV iron), but consider all the people who self-administer Vitamin D (and iron) pills, which may soon include people on in-center and home dialysis under bundled payment.

Government always knows best.

If you are willing to take the risk and can convince your physician and your dialysis clinic, and if their legal department is willing to accept a signed waiver of liability that states explicitly that your estate and no one in your family will sue the clinic or the physician for your death or other bad outcome if you go into anaphylactic shock, go for it.

I suspect when bundling takes effect fully, facilities will closely evaluate the need for ESAs and iron. I suspect as many patients as possible will be switched to oral iron as a cost saving mechanism. The range of hemoglobin CMS is expecting clinics to shoot for is 10-12. Clinics will do fine if most of their patients have Hgb of 10, but patients may notice a difference if they’re trying to keep active.

I live three blocks away from a major research hospital that treats dialysis patients, all of the time. I have taken a ton of Iron, over the past 3 and half years, have never had a reaction, ever. My point is that it should be decided by the Nephrologist, the clinic, and the patient. Government needs to mind their own business.

What you don’t seem to understand is that the government is not PREVENTING the use of IV iron at home. The government (FDA) is warning professionals about the risks and letting the professional and patient make the decision, as has happened in your case. Bet some of those people who would have died when they had an anaphylactic shock reaction at a hospital or dialysis clinic or doctor’s office are glad that they were supervised when they got their dose of IV iron. And remember, just because you’ve never had a problem before doesn’t mean that you won’t have a problem next time. As long as you understand that, it’s your life and your choice.

Good enough.