Some of the home patients in one of my list serves are allowed to give themselves IV iron at home. In our program we can not. I asked my nurse the reason and she said that Medicare will only pay for IV iron if it is given in the unit. Do you know why patients are permitted to give IV iron at home in some states while not in others? And what difference does it make if it is given in a unit or at home? Dr. Agar stated that all his home patients are trained to give themselves IV iron at home and there has never been an incident to his knowledge in all the years of the program.
I received new info that it is NOT Medicare that determines if iron can be given at home, rather it is the secondary insurer. Therefor, home patients in the same program are either allowed or not allowed to give iron at home. If this is correct, then I just need an answer to why those with an insurer who disallows giving iron at home would do this. Is it a payment issue or a safety issue? This is another example of it being a waste of time and resources to have to drive to the unit to get iron over 20 min. when it could be given at home. And it is not just a one time thing- it may be a 5 session iron load that ties up 5 days. That means extra stress, lost wages, childcare etc. Is it possible for a neph to override this regulation?
Most self-administered drugs are not covered by Medicare Part B–EPO is an exception but Medicare Part B covers EPO for dialysis patients when provided by/through a dialysis clinic. For home patients Medicare will pay if it is self-administered, but only after the patient has been taught how to safely store it, administer it, monitor dietary intake of food/fluid for high potassium and high BP, and to report symptoms. Currently, IV iron is a Medicare Part B covered drug when provided by a dialysis clinic, a hospital outpatient department or a critical access hospital.
Here’s the section from the Medicare Benefit Policy Manual, Chapter 11 for ESRD:
[I]220.127.116.11 - Intravenous Iron Therapy
(Rev. 1, 10-01-03)
B3-4461, A3-3644.E, RDF-319.4
Iron deficiency is a common condition in ESRD patients undergoing hemodialysis. Iron is a critical structural component of hemoglobin, a key protein found in normal red blood cells (RBCs), which transports oxygen. Without this important building block, anemic patients experience difficulty in restoring adequate, healthy RBC (hematocrit) levels. Clinical management of iron deficiency involves treating patients with iron replacement products while they undergo hemodialysis.
For claims with dates of service on or after December 1, 2000, Medicare covers sodium ferric gluconate complex in sucrose injection for first line treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoeitin therapy. In hospital outpatient departments, payment is made under the outpatient prospective payment system. Payment is made on a reasonable cost basis in critical access hospitals (CAHs). For claims with dates of service on or after December 1, 2000, payment is made on a reasonable cost basis in renal dialysis centers (freestanding facilities). For claims with dates of service on or after January 1, 2001, payment is made pursuant to 42 CFR 405.517 for renal dialysis centers (freestanding facilities).
Medicare covers iron sucrose injection as a first line treatment of iron deficiency anemia, when furnished intravenously to patients undergoing chronic hemodialysis who are
receiving supplemental erythropoeitin therapy, for claims with dates of service on or after October 1, 2001. In hospital outpatient departments, payment is made under the outpatient prospective payment system. Payment is made on a reasonable cost basis in CAHs and in renal dialysis centers (freestanding facilities). Deductible and coinsurance apply.[/I]
Iron is classified as a mineral and thus is not covered by the standard Medicare Part D plan. If a patient has a Medigap plan (Medicare supplement), it would pay for any Part B covered drug after Medicare pays, but would not pay for any drug that Medicare does not cover. Whether someone can buy IV iron through a pharmacy using their employer group or individual health plan benefit depends on that plan’s coverage policy and whether the prescribed IV product is on the plan’s formulary.
The main reason why dialysis clinics require patients to come to the clinic to get the IV iron is so they can be observed for any hypersensitivity reaction. So this is a safety issue. All IV iron products – iron dextran (INFeD, Dexferrum), iron sucrose (Venofer), and sodium ferric gluconate (Ferrlecit) have some risk of hypersensitivity reactions that can range from mild to severe, including anaphylactic shock and death. Therefore, manufacturers recommend a test dose be given and do not recommend self-administration. It’s my understanding that someone who previously had no problem could develop a hypersensitivity reaction too. Some clinics have assessed the risk and believe it is low enough that they choose to allow their patients to self-administer rather than inconvenience them by requiring them to come to clinic. If a clinic is going to allow patients to self-administer, in my opinion, staff should inform patients of the risks, symptoms to watch for, and what to do (call 9-1-1) if they begin experiencing symptoms that might be related to hypersensitivity.