Tell it to CMS

Discussions for Patients, Family, and Friends HD For Patients
1

The Centers for Medicase & Medicaid Services (CMS) is currently going through the process of finalizing the details of bundling. Let’s make sure they hear the concerns of home dialyzors. Please send them your story and how home treatments have affected your life. If you were a previous in-center dialyzor, make sure you tell them the differences. If your outcomes are better now, as they surely are, emphasize how much better they are. If your using fewer meds, mention that. If your hospitalization days are down, mention that. Do whatever you can to convince CMS how much better home dialysis is than in-center.

email to:
Dr. Barry Straube, MD.
Acting Chief Medical Director
Centers for Medicare & Medicaid Services
barry.straube@cms.hhs.gov

2

PLEASE do this, folks. We can’t assume that people at CMS are thinking about the benefits of more frequent or longer treatments–or how those might be harmed by a “bundled” system that pays by the week, or month, for example, which would create an incentive to give as FEW treatments as possible… Share your stories!. Post in this thread to let us know you did. :slight_smile:

3

I just sent my email to Dr. Barry Straube. Thanks for posting this.

4

Dear Ms. Ramsay:

Thank you very much for your email. I don’t know if you are aware, but I am a nephrologist and transplant physician by background and I am very sensitive to doing everything I can at CMS to make sure the agency does not make policy decisions that lead to unintended consequences. Right now, a proposed rule is being drafted concerning the bundled payment system that Congress has told us to develop in Section 153(b) of the Medicare Improvements for Patients and Providers Act (MIPPA) of 2008. The proposed rule, which will probably be published and open to public comment this summer, will contain proposals about how the bundled payment is to be constructed and the rationale behind that. There will be public comment after that and CMS has to respond to all of the comments in developing a final rule (regulation) months later. There are many complicated issues that will need to be carefully considered, home dialysis being one of those very, very important issues. Since the proposed rule isn’t finished being drafted, I’m surprised to hear that someone may have led you to believe that we’re doing something to change your current care. That is not the case at this time.

I am very pleased to hear how well you are doing with daily home dialysis. I have heard from a number of patients who have told me similar stories. We’ll be examining the current medical literature to see whether current reimbursement should be changed to accomodate this issue, let alone many other issues. Unfortunately, Congress passed the MIPPA law to address the overuse of several expensive medications, Epogen or Aranesp being the two most often abused, even after safety concerns were raised for those two medications. That means we also have to be careful to not authorize payment for treatments that aren’t proven to be necessary or safe. We’ll certainly work very hard to get the policy right and input from patients like you is very helpful.

Thanks, again, for contacting me and I’ll certainly pass along your comments to other senior leaders and staff at CMS.

Sincerely,

Barry M. Straube, M.D.
CMS Chief Medical Officer
Director, Office of Clinical Standards & Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Phone: (410) 786-6841
Email: Barry.Straube@cms.hhs.gov

From: Scot & Wendy Ramsay [mailto:swramsay@comcast.net]
Sent: Sun 5/17/2009 10:05 PM
To: Straube, Barry M. (CMS/OCSQ)
Subject: Daily Home Dialysis / Bundling

Dr. Barry Straube, MD.
Acting Chief Medical Director
Centers for Medicare & Medicaid Services
barry.straube@cms.hhs.gov

Dear Dr. Straube,
I do not fully understand how the pending changes to bundling will affect the frequency of home dialysis and thus the quality of my life. I do know how daily home dialysis has changed my life and health for the better and wish to share some of that with you as decisions are being made that could affect that.

I started dialysis in September of 2008 after removal of my second kidney to bladder cancer. Initially, I was dialyzing 3 days a week in-center for 4 hours each time. I had a very difficult time with fluids and great fatigue. My potassium and phosphorus levels remained dangerously high despite careful food intake and abundant phosphorus binder drugs. My platelets remained dangerously low in part due to the heparin used during dialysis. I was taken off heparin and saline flushes were given to me every 15 minutes for 4 hours each dialysis session. Three out of four times, my blood would clot after two hours cutting my runs short or requiring a brand new set up. Many times I was unable to have to blood returned to me that was already in the circuit because of clotting leaving me anemic and in need of more drugs. Twice, I needed surgical replacement of the catheter access because of clotting. The times my runs were cut short, I scheduled additional days to make up for missed dialysis.

Two months ago, I began home dialysis in my home 6 days a week for just over 2 hours each run. For the first time since I began dialysis, my potassium, phosphorus and platelets are normal. Epogen ( a very expensive drug) requirements have been drastically reduced. I use a fraction of the heparin that I needed during in-center dialysis. I have normal energy. I can maintain a normal diet and fluid intake and have regained a healthy appetite. I exercise at the gym three days a week. The greatest blessings are to be home with my young son and husband as I dialyze and to have the health and energy to be there 100% for them as a mother and wife.

I don’t know what I would do if the frequency that I am able to dialyze is reduced. It would negatively impact my health and the quality of my life and my family’s life. Daily home dialysis has restored my health and given me my life back. My precious son has his mother back. Please make sure that is not taken away from me. Thank you, sir.

Respectfully,
Wendy Ramsay

Home Dialysis Patient
NxStage Pureflow 6 x’s week / 2.25 hrs each

5

Wendy, thank you for the very strong message you sent to Dr. Straube. We need to have more sent similar to yours. CMS hae to hear from dialysors like us. They’ve been given a very difficult task, but the more they hear from home dialyzors the more they’ll understand that we’re noth the problem, but the solution. One of their goals is to reduce the cost associated with Epogen. I think we can prove to them that home dialysis is the way to secure the changes they have been commissioned to do. I’m sure Amgen’s not too keen about this, but but we have proven that anemia can be best controlled with lots more dialysis and a modicum of meds.

6

Beth tells me that it may make sense to hold comments until there IS a public comment period, because then CMS has to log them in and pay attention to them–before then, they don’t, although it was very kind of Dr. Straub to read and respond to Wendy’s email.

7

I’ll just send it again during the public comment period.

8

Hi Folks

What Time line do we have???

Thank s

Bob Obrien

9

Rich,
The email you gave me doesn’t work. I’ll need another one in order to forward my email to you. My email: swramsay@comcast.net.

10

Dr. Straube- “Unfortunately, Congress passed the MIPPA law to address the overuse of several expensive medications, Epogen or Aranesp being the two most often abused, even after safety concerns were raised for those two medications. That means we also have to be careful to not authorize payment for treatments that aren’t proven to be necessary or safe. We’ll certainly work very hard to get the policy right…”

Is Dr. Straub saying the clinics are not performing EPO administration correctly resulting in overuse or is he also saying clinics are still profiting from EPO?

11

I read that as, the MIPPA legislation was passed to prevent what was considered overuse of EPO.

12

The Medicare Improvements for Patients and Providers Act is a large piece of legislation with just a relative small part related to ESRD. You can read the whole bill if you have trouble sleeping (it’s 103 pages long), or read about Medicare related to kidney disease in Sections 152 and 153 on pages 58-67. The part on bundling is on pages 60-63.
http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_bills&docid=f:h6331enr.txt.pdf

So far as writing letters to CMS, here’s information that I got from a CMS staffer I asked about when people should write. So far as how long people will have to send their comments, it depends. This information is provided in the proposed rule when it’s published along with where and how to send comments. I’ve seen comment periods as short as 30 days and as long as 90 days. BTW, “benes” is a CMS term for beneficiaries (people with Medicare).

[I]I would advise them to wait until the comment period. Every comment is considered and they really do take into account those comments before finalizing. It is common that modifications are made before finalizing because of comments to the proposed. I would suggest that in addition to any ‘complaints’ they may include in the comment, concrete recommendations are included. This puts CMS in the position to determine if they want to incorporate the recommendations, and if not, provide a valid reason. If they receive letters that simply register complaints, but does not offer solutions, they will research possible solutions—but I believe that it is much more effective to offer the concrete solutions/recommendations in the comments. Sometimes, benes can provide insights with their recommendations that policy makers don’t ever think about when developing solutions.

Letters that are received outside of regulations or other requests for public comments are routed to the appropriate department in CMS – and a reply is given. Usually, those response letters acknowledge the concern expressed and thanks them for their interest. Likely, the letter may direct them to the comment period anyway.[/I]

Hope this helps.

13

Beth, that may be all well and good, and it makes certain sense to write when the public comment perios is open. But let’s not get caught by surprise and find out we don’t have much time to organize. We know the time is coming up shortly, perhaps as soon as the middle of June. My hope is that we aren’t just reactive, but proactive. Bundling starts in 2011, but the decisions are being made now. It’s a probability we won’t get everything we want, but the Notice of Proposed Rulemaking is coming, and we shouldn’t lose a beat.

Your suggestion of making recommendations, and just not being negative, makes a lot of sense. My suggestion is that people can start writing a first draft now, and then go back to it whence the proposals come out. Keep it fresh in your mind so you can sring forth when the time is ready. We only get one chance to affect change – let’s do it right.

14

Rich,
Why don’t you ask Dr. Straube what his recommendations would be regarding submitting comments? What is the most effective timing and method…now or later or both?

15

I would never discourage anyone from being proactive, writing a draft letter now that could be tweaked later, and developing an advocacy network to send letters to CMS during the public comment period. Here’s what I remember of how Medical Education Institute was able to get so many of its key positions into the Conditions for Coverage (CfC) when it was published – Dori, feel free to add to this anything I forgot to mention:
– MEI solicited input for what issues were important from those who would be affected by the change in regulation (friends who were providers and consumers)
– MEI wrote a position paper and included references to journal articles that supported MEI’s positions;
– MEI waited for the proposed regulation to be published and tweaked the position paper to comment positively on things we liked and make suggestions about those things that we thought needed to be changed to be in line with MEI’s positions;
– MEI sent the position paper to multiple organizations and individuals we believed would be supportive of our positions and encouraged them to include anything we wrote in their positions – the Council of Nephrology Social Workers included everything we wrote in their document which was incorporated into NKF’s comment);
– MEI waited to see which of our positions would be incorporated into the Final Rule and saw that many were, including an annual requirement to measure physical and mental functioning using a standardized survey to get dialysis providers to begin to look at those they treat more holistically.

Something that I believe could be helpful during this waiting time would be to survey or poll people on home dialysis (and those who care about them) about what issues worry them related to bundling. There may be other issues besides the obvious ones. Develop a bullet list of issues and begin researching to find references. The bullet list and references could be posted on Home Dialysis Central. This would help those who wanted to write letters have the ammunition they need to include along with their personal stories that personalize the research data.

At the same time, it would help to develop a list of organizations that would likely have the same concerns. When the Notice of Proposed Rulemaking is published on bundling, the position paper could be tweaked quickly and sent to those organizations just like MEI sent its CfC position paper to organizations in a successful advocacy effort related to the CfC.

16

I’ll take care of that today.

17

Dear Dr. Straube:

I am a home dialysis patient with a B.A. in Government/Economics. When I was a patient in the In-Center clinic, I never received enough dialysis. Years ago, I was an offensive lineman and a heavyweight wrestler. My last bench press was 330 x 20. In addition, when I was a patient at the In-center clinic, I had to constantly go to the hospital because I acquired staph infections fron the clinic. Now, that I am on home dialysis, I have not been sick in almost two years. With home dialysis, I do not feel washed out after a treatment. I know that you are concerned about costs, home dialysis is much cheaper than In-Clinic dialysis. Let us look at costs, I love to talk about money. First, if Medicare would cover Home Dialysis or Home Nocturnal Dialysis, this would be a great cost saving to the taxpayer. Even if the patient is performing home nocturnal dialysis, 7 days per week, the taxpayer is saving $10,000 per patient, per year. Second, with Home Nocturnal dialysis, the taxpayer is not paying for expensive medication, such as Phosphorus medications or thyroid medication, these medications cost a fortune. With full Nocturnal dialysis, you would eliminate the need to take that medication, a huge cost savings. Third, with Home Nocturnal dialysis, the average day a Nocturnal dialysis patient will spend in the hospital is only two days per year. I want you to contrast that figure with the average hospital time of a In-Center patient of seventeen days per year, per UCLA Nephrology. Fourth, with Nocturnal dialysis, you eliminate the need for high cost Nursing asistance. I love nurses and a few in my family are a nurses. The taxpayer is not paying for the high cost of Nursing. Fifth, with Nocturnal dialysis, you eliminate the need to pay for the costs of the dialysis building. Sixth, with the elimination of the building, no need to pay for interest costs on the dialysis building. Seventh, with home nocturnal dialysis, you do not have a need to pay transportation costs to get to and from the dialysis clinic. Eighth, in just about every case, with home Nocturnal dialysis, patients are able to return to the workforce and pay taxes, once again. Nineth, more taxpayers will equal higher tax revenue to the goverment. The G.I. Bill was one of the great investments by the government, returning eight times the amount of tax revenue spent by the government. As a taxpayer, I want to save money. The best way to save money for the taxpayer is to consider all costs of dialysis. I would not wish this current system on my worst enemy. The right thing to do is also the compassionate thing to do and along with that action, saving the taxpayer, tons and tons of money over many years. Home dialysis is a win for the patient and a big win for the taxpayer.

Mark Moulliet
Cincinnati, Ohio

18

Mark, great letter! Sounds like your BA in Governments and Economics has finally paid off.

19

Thanks. I know there would be many innocent people affected by this proposed rule. However, you and everyone has to remember, this legislation is not even close to being finished. Call your Senator or Rep in the House, that is why they are there, TO SERVE YOU.

Goverment serves the people, not the other way around,

Mark

20

The requirement that CMS develop a bundle of services for dialysis is law (Medicare Improvements for Patients and Providers Act).

What is still up in the air is how CMS will implement the law and how it will affect patients and providers. Also up in the air is whether Congress will choose to backpedal on any of the ESRD and CKD provisions in MIPPA including the bundling requirement.