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Medicare proposed changes

This was posted on the ACOR MM list. I hope we’ll all take some action!
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For those of you who do not live in the US, I apologize. I also apologize for adding this to everyone’s email. I haven’t don’t this before so …

Apparently someone in the Center for Medicare Services (CMS) has come up with the following idea to save money. They will limit the number of times that certain laboratory tests will be reimbursed. CMS calls these tests Medically Unbelievable Edits (MUE’s).

Here are some examples of what will happen:
If a patient has a culture and sensitivity that determines what bacteria might be causing an infection and which antimicrobials will/will not work, then you can only have two per day. So don’t have bacteria in three places on the same day. One culture will have to wait for the next day

We all know of people who get more than one unit of blood per day in out-patient settings. Well, under this regulation, you will only be able to get 1 crossmatch per day which effectively limits you to one unit per day. And that will dramatically affect the treatment of anemia in out patients.

In the case of serum protein immunoelectrophoresis, CMS proposes to pay for only one assay per day. Specifically, you can get an IgG level but not an IgA or IgM on the same day.

In the case of flow cytometry, they will pay for 2 probes on any given day. Would you prefer CD5 and Cd 19 or CD20 and CD38 because you need to space them out over time? Where you usually can get a panel of molecular diagnostic markers performed at the same time, they will only pay for 1 a day. So, if your cells need to be tested with 10 markers, you need to have 1 performed per day.

In addition to detracting significantly from patient care, laboratory personnel will probably not refuse to perform these tests. But they won’t be able to bill Medicare for them. That means that they will either try to eat the cost (although that breaks a 19th century federal law on fraud and abuse) or charge the patient – except in those states that have no balance billing laws. Small laboratories such as Physician Office Laboratories or clinic laboratories or community hospital laboratories may go bankrupt and close or severely limit their service.

My suggestion is to call/email your Senators and Representatives to have them put pressure on CMS to withdraw this idea. You can also write directly to
Mark McClellan, M.D., Ph.D.
Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Attention: CMS-1502-FC
Room 445-G, HHH building
200 Independence Ave SW
Washington, DC 20201

The comment period ends on March 30 and unless turned back will go into effect on July 1, 2006.


Susan J. Leclair, Ph.D., CLS(NCA)
Chancellor Professor
Department of Medical Laboratory Science
University of Massachusetts Dartmouth
Dartmouth, Massachusetts 02747-2300

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Buddy

What a cute doggieHere’s a picture of Buddy after a haircut. We’re about to go out for a walk, which is his favorite time of day. He always knows when it’s time, because I put on my shoes. I actually can’t stand wearing shoes since I got neuropathy from the thalidomide. No longer do I have the joy of buying comfy new shoes.

Buddy is half collie and half golden retriever. His head is definitely retriever. However, he has no interest in retrieving anything!

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Sleep over

I had my neice and nephew (7 and 4) stay over last night. It was a fun time. Kids get up early! We made “cars” from cardboard boxes this morning and had breakfast in bed. They’ve gone home now, so it’s quiet here. For some reason, they decided to help me sweep and mop the kitchen floor! Is this why people have kids?

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Latest Labs

I have some latest lab reports posted. You can see them by clicking on “my Labs.”

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Cancer Stem Cells

Read through this and let me know what you think. A lot of folks believe that there are cancer stem cells, and those need to be the target of research.

> Dear Friends,

> Dr. Matsui sent this wonderful reply to me late this evening.
> Describing the difficulties of getting people to believe the findings
> and then to test appropriate agents, he supports Dr. Richardson
> description of Matsui’s work as “preliminary.” I think he’d like
> the patient community to spread the word. (Or I would. Probably just
> reading between his lines!)
> His message clarifies (for me) why Hopkins is using Rituxan despite
> the fact that it will likely affect all B cells. They feel they can
> support those whose immune systems are suppressed as is already done
> for persons with genetic disorders that prevent normal development of
> antibodies. He is testing many other agents. He also mentions that
> proteasome inhibitors may attack cancer stem cells. This raises both
> velcade and NPI-504 in my mind. (Recall, taking Rituxan could
> disqualify one from the NPI-504 trial, as it does the PR-171 trial.)

> Finally, I note that he thinks that the active ingredient in fever
> few would be a good agent to test. Since I can buy some form –
> probably not strong or pure enough to matter — nonetheless, I’m
> giving it to my guy NOW.

> What an amazingly generous communication from such a busy, high-
> powered researcher! (Nick, thank you for helping refine the
> questions!)

> Best wishes,
> D.

> Begin forwarded message:

>> From: William Matsui
>> Date: February 22, 2006 10:53:50 PM EST
>> Subject: Re: Follow-up questions?

>> Dr. Wicha passed this message on to me and I had a few thoughts…

>>

>> Like our colleagues at Michigan, we (at Hopkins) believe that cance
>> stem cells lie at the heart of developing effective therapies that
>> can truly result in long-term remissions. The cancer stem cell
>> hypothesis currently is just that, a hypothesis. We believe that we
>> have solid evidence that specific cell populations (stem cells) are
>> able to give rise to myeloma in the laboratory, but the ultimate
>> proof will come from finding effective stem cell targeting agents,
>> then testing them in patients and showing that they can prolong their
>> lives. As you might imagine, this is a formidable task…. Using
>> acute leukemia (AML) as an example, the stem cells in this disease
>> were first identified in the early 90’s. Potential leukemic stem
>> cell targets (the interleukin-3
>> (IL-3) receptor and proteosomes) were described a few years later,
>> but neither of these targets have been seriously studied in the
>> disease (Velcade is a proteosome inhibitor and should have activity
>> against the cells, and has been tested only in a limited fashion in a
>> single published study). So AML (in which few would argue the
>> existence of stem
>> cells) illustrates the difficulties decscribing the laboratory
>> findings, getting people to believe the data, then carrying out a
>> clinical trial that would ultimately prove the point. Hopefully,
>> trials that suggest that the theory is correct, like our Rituxan
>> trial or the Michigan Bexxar trial (that would hopefully extend the
>> length of remissions, but are not likely to cure myeloma-since each
>> agent has curative benefit in only limited cases of lymphoma) will
>> give us the evidence we need to perform future clinical trials using
>> drugs that we think may truly eliminate myeloma stem cells.

>> For our trial at Hopkins, we chose to use Rituxan largely because of
>> its lack of serious side effects and our data from the laboratory.
>> I do
>> not know whether any other investigators have repeated our
>> experiments, but I do know many researcher have asked me to help them
>> with the laboratory assays to detect growth of the stem cells (so
>> maybe confirmatory results are coming). I agree that parthenolide is
>> a promising drug in leukemia and would certainally make sense to test
>> in MM. We are looking at several agents in the lab to test their
>> anti- stem cell activity. Some are focused on agents that can
>> inhibit B cells (regardless if they are myeloma derived or not),
>> others on pathways that we think are shared my stem cells from many
>> different tissues and organs. For the latter set of drugs, there is
>> certainally concern that they will affect normal stem cells so much
>> testing is likely needed prior to their standardly being used. As
>> for myeloma, my hope is that we can eliminate most all B cells since
>> the greatest risk of this approach would likely be a period of
>> immunodeficiency (due to the loss of normal antibody production).
>> But there are individuals with genetic defects that lead to
>> immunodeficient states that can really lead normal lives with
>> antibodies given every 1-2 weeks, and I would expect that the B cell
>> pool to be “replenished” by new B cells made from hematopoietic stem
>> cells.

>> Hope that this answers a few questions. Please don’t hesistate to
>> contact me if you have any others.

>> Bill

>> William Matsui, MD
>> Assistant Professor of Oncology
>> Division of Hematologic Malignancies
>> The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The
>> Bunting Blaustein Cancer Research Building Room 245 1650 Orleans
>> Street Baltimore, MD 21231

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