By Bill Peckham
I think it is fair to ask what letter I would support, as is often said, it's easy to be a critic. This is the letter I would like to read from four of the leading CKD advocacy groups. I changed the date and the approach:
March 25, 2010
Dear Members of Congress:We congratulate Congress on the historic vote and the passage of legislation to reform the health system, HR 3590 the Patient Protection and Affordable Care Act. These reforms will benefit people with chronic kidney disease, particularly by ending the practice of excluding people with preexisting conditions from participation in the health insurance market and action to close the so called "Part D donut hole". Thank you.
The dialysis community has been working to implement previously legislated reforms, we are writing to ask your help with that process.
The Centers for Medicare and Medicaid Services (CMS) is in the midst of finalizing its End Stage Renal Disease (ESRD) Prospective Payment System (PPS) Rule. The rule implements provisions in the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) that require the Agency to establish a bundled payment system for dialysis services. CMS published the proposed rule last September 16th; the comment period closed December 17.
One measure in HR 3590 that is specific to the ESRD program, Section 10336, directs that:The Comptroller General of the United States shall conduct a study on the impact on Medicare beneficiary access to high-quality dialysis services of including specified oral drugs that are furnished to such beneficiaries for the treatment of end stage renal disease in the bundled prospective payment system ...We believe that this provision brings helpful clarity to the choices CMS must make as it prepares the PPS final rule.In September CMS proposed to shift all oral drugs without injectable equivalents, including calcimimetics and phosphate binders (oral drugs), into the bundle. This proposed policy was the subject of the most public comments during the PPS's comment period. The vast majority of these comments, including the vast majority of comments from people who use dialysis, spoke against the idea of including oral drugs at this time. We feel this consensus position should be supported and we urge Congress to make clear that the GAO report is meant to be a prospective study, that this study should inform the future process of including oral drugs in the PPS.
We believe that CMS can implement the PPS program MIPPA requires in a way that improves care for individuals who need dialysis services and does not endanger the progress in quality of care made in recent years. However, for that to happen CMS must wait for the GAO to study including oral drugs, and allow the implementation of MIPPA to proceed without their inclusion.
We ask that you contact CMS to underscore the intent of your recent legislation. It should be made clear that the study required by Section 10336 should be completed before CMS acts to include oral drugs under the dialysis PPS. By clarifying the intent of the GAO report, you will be supporting the concerns of Medicare beneficiaries.
We asked the beneficiary community, the people who use dialysis, and their loved ones, to engage with the PPS comment process, and they came through with scores of thoughtful, actionable comments. Reading through these many comments it is clear that aside from the inclusion of oral drugs, beneficiaries are most concerned about CMS's method for including laboratory services (labs) and the inclusion of home dialysis training under the routine PPS payment. The comments not only identified the problems they offered solutions. These comments should be acted upon.
We request that you encourage CMS to take seriously the thoughtful comments of beneficiaries, and the thoughtful and actionable comments of the organizations who represent individuals who need life-saving dialysis care, including the undersigned. The issues are complex and there is limited time to act, but CMS must get the policies right. At stake is the health and well being of hundreds of thousands of Medicare beneficiaries.
Warm regards,
Maybe the idea is that members of Congress don't have to meet the various comment period deadlines but it seems to me that the place to advocate now is where legislation has created an opening.
The approach of getting Congress to challenge CMS's results could have unintended consequences. Assuming HR 3590 the Patient Protection and Affordable Care Act passes, advocates would be wise to build on the language to study the inclusion of oral drugs and hope that they made their case sufficiently on other issues while the comment period was open.





Brilliant, Bill. They should have consulted you before they sent that weird missive last week.
Posted by: Miriam | March 20, 2010 at 08:39 AM
Much better letter than the one written, but I'm still not convinced one should have been written in the first place. With everything going on in Congress regarding health care, staff members are currently absorbed with that. Although it's necessary to keep in constant contact, there's an art in when to ask for something, and now isn't the time. It would have been more appropriate to write a letter to Representatives during the Open Comment period.
I, too, see how this can cause unintended consequences. CMS doesn't need the additional pressure now, which more or less is after the fact. There's no doubt in my mind the final rule will not be all we would desire. But that fight will have to wait for another day. In dealing with our Reps now, I think it should be low key and more educational in nature. Let's build support now so when we do have an "ask", there will be more receptive ears.
Posted by: Rich Berkowitz | March 20, 2010 at 11:22 AM