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.
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
From: Scot & Wendy Ramsay [mailto:firstname.lastname@example.org]
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
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.
Home Dialysis Patient
NxStage Pureflow 6 x’s week / 2.25 hrs each