Conditions for Coverage
You can have input into the Federal Regulations for Dialysis
Dialysis clinics are mainly governed by federal regulations, called the Conditions for Coverage of Suppliers of End-Stage Renal Disease Services—a set of rules used by Medicare surveyors when they inspect dialysis clinics. These regulations were published in 1976, and remain virtually unchanged. Since the late 1980's, we've been told that new regulations were underway and would be published "soon." Patient advocates and providers have anxiously waited to see what the new regulations would require.
The new proposed regulations have now been published for public comment. The comment period ends at 5:00 p.m. on Thursday, May 5th, 2005. Medicare must read, catalog, and consider all comments they receive during the public comment period.
Below is a quick summary of the contents of the new regulations to help you decide if you want to comment. (For a more complete list of specific comments, contact the Medical Education Institute to request our comment document).
Section 494.50 - Water Quality
Should dialysis water meet AAMI standards for purity—or should an even higher standard (such as ultrapure dialysate) be required? Studies suggest that ultrapure dialysate can slow loss of remaining kidney function, improve response to EPO for anemia, reduce inflammation throughout the body, improve nutrition, reduce the risk of amyloidosis, and reduce deaths from heart disease.
Section 494.70 - Patient's Rights
This section currently includes a list of what patients have the right to know, but nothing that they have the right to do. For example, would you like to have the right to:
- Have a work-friendly modality (PD or home hemodialysis) or schedule that accommodates work or school?
- Receive referrals for mental health services, physical or occupational therapy, and/or vocational rehabilitation?
- Be told of all available treatments (including PD and home hemo) and where they are offered?
- Be informed that self-cannulation (putting in your own needles) is possible and be offered training to self-cannulate?
- Be informed of topical analgesics for needle pain and how to obtain them?
- Refuse cannulation by a nurse or technician if access problems occurred with that staff member in the past?
- Attend your own care plan meetings?
- Not be involuntarily discharged from a clinic for non-adherence with the treatment plan?
If any of these rights seem important to you—or if you believe patients should have other rights that they don't currently have—you'll want to comment by May 5.
Section 494.80 - Patient Assessment
Is dialysis just supposed to clean your blood? Or is the purpose of dialysis to make it possible for you to live an active and productive life? At the Medical Education Institute, we believe the second statement reflects the intent of Congress when they created the Medicare ESRD Program in 1973. So, we suggest adding a requirement to measure patients' physical and mental functioning (using any standardized test) along with the lab tests that are followed to see how you are doing on dialysis.
Physical and mental functioning are measured with a paper-and-pencil test that you take, which is then scored and compared to national averages. Results of these tests predict hospitalization and death on dialysis as well as Kt/V or serum albumin—so improving physical and mental functioning may help patients live longer and better.
Section 494.90: Patient Plan of Care
Currently, the regulations do not set any floor for dialysis care. If you would like to make sure that the regulations at least use the K/DOQI guidelines for dialysis dose, nutrition, and anemia treatment, you'll need to make a comment.
In this section, you can also comment on patients' access to home dialysis treatments, and on rehabilitation goals for patients. The Medical Education Institute suggests:
- Maximizing physical and mental functioning
- Helping patients keep their jobs or finish school
What educational topics are key for patients to live long and live well? The Medical Education Institute's list includes:
- Nature and management of ESRD
- All types of dialysis and how they are done
- How to follow the renal diet, fluids, and medications
- How to read, understand, and use lab tests to track clinic status
- How to be an active partner in care
- How to achieve and maintain physical, vocational, emotional, and social well-being
- How to detect, report, and manage symptoms and complications
- What resources are available and how to use them
- How to handle medical and non-medical emergencies
- How to reduce the risk of infection
- How to properly dispose of medical waste
Section 494.140 - Personnel Qualifications
Do you have an opinion about dialysis technician training? Making a comment on the Conditions for Coverage may be your best chance to share your thoughts about what is important for technicians to know and do.
How to Comment on the Conditions for Coverage
You can comment on-line, by following this link. Please include CMS-3818-P in your comments, so Medicare knows which regulations you are commenting on.
This is your chance to have input into how dialysis is provided in the U.S. Don't let it pass you by!