I'll be the first to say I don't know much about Medicare and am not covered by it, myself. But since almost everyone in the US ends up there, sooner or later, I have thrown myself into the controversy regarding the recent restriction of Sandostatin LAR.
To be clear, Medicare does not restrict prescriptions of the drug in doses larger than 30 mg./month. It has been refusing to provide coverage (payment) for more than that amount in many cases. That leaves lots of folks with carcinoid trying to self-inject the generic form of the drug, octreotide acetate or find an additional stash of money (in the $thousands) to keep their symptoms (diarrhea you would not imagine) at bay.
I contacted Medicarerights.org, a non-profit volunteer group that answers questions for the public. Andy Olesker answered and here's what he had to say. Please read all the way to the end as I think this might be very important to anyone on Medicare - even if you are not looking for larger doses of Sando LAR.
| Medicare Rights Group at www.medicarerights.org/ A pleasant guy named Andy responded. He says he doesn't usually get such interesting queries. After I gave him the basics of carcinoid and Sando LAR, he said the following: You have to get your doctor or a doctor involved. He has to write a letter of appeal (not news, I know) that is backed by research (done by you, of course.) He said there are some crucial features: The drug must be in one of the three Medicare compendiums. There is no open access to this compendium, he claims. Only doctors can get into it. IF the drug is in the compendium for use for anything at all (in the case of Sando LAR, it was originally for treatment of Acromeagly - pronounced Akro-Mu-GOLLY, a serious illness at least as bad as carcinoid.) It can be prescribed as "off-label use." Andy claims that the off-label use can also apply to the prescribed amount. He says few doctors are fully aware of the Medicare laws and the new federal law passed in January 09, which accepts anti-cancer drugs into additional compendia. Furthermore, if a certain drug is shown in medical literature to be acceptable in greater doses, it can be prescribed. This law apparently was aimed at letting people with cancer out of an earlier, more restrictive law that tries to stop doctors from prescribing off-label because they get kickbacks from drug manufacturers for prescribing stuff never approved by the FDA for that purpose. You may recall Novartis was fined heavily for doing this very thing. An epilepsy drug was being prescribed to heal peripheral nerve damage (like from diabetes) although it was not supported by studies and the FDA had never approved it for that use. If a person on Medicare has a supplementary drug plan, his doctor can apply for an exception to get the drug covered in the increased dose through the regular Medicare appeals process. (How long does that take?) If the drug plan says no, it becomes a matter of off-label use and an appeal has to be filed for that through a regular Medicare appeal process. (How long does THAT take?) I assume if you have no supplementary drug plan, you go straight to the regular Medicare appeal. Here's the important part, your doctor should cite this change in the law: A covered part D drug (i.e., one which Medicare covers) must be prescribed for a medically accepted indication, as defined in 42 US Code Section 1395w-102(e)(4). This means, in general, that (a) both the drug and its use are approved by the FDA or (b) the drug is FDA-approved and its use is supported by one or another of three or four compendia, such as the AMA Drug Evaluations. However, in the case of a drug used in an anticancer chemotherapeutic regimen, it is also a medically accepted indication if the use of the drug is medically accepted based on supportive clinical evidence in peer reviewed medical literature appearing in publications which have been identified by the Secretary of Health and Human Services. 42 US Code Sections 1395w-102(e)(4)(a)(i) and 1395x-(t)(2)(B)(ii)(II). BONUS FEATURE: Andy told me more people with carcinoid could probably get the infusion pump if they try. He said the pump should be covered as durable medical equipment. I know two people in Texas who got the pump through Medicare. If you have the energy to take this fight a step further, I strongly suggest you get the pump. That means you will be using octreotide acetate - a lot easier drug to work with. It's generic, so the cost is much lower. Self-administered, so no doctors' appointments. Best of all: no butt lumps. I'm back on the pump, myself. It is a slight bother at times but nothing major. You learn in a couple of weeks how to work it and it becomes second-nature. There's something to be said for that even flow of octreotide into the body, too. I believe it is one of the factors in keeping my disease at a slow roll. |
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