Become Certified

Do you have a new dialysis clinic that wants to offer home dialysis training and support? Or, would you like to add PD and/or home HD to an existing certification? Either way, take the steps below to comply with the Federal Medicare Conditions for Coverage (CfC) for End-Stage Renal Disease Facilities.

Required Forms and Documentation

STEP 1:

Electronic Option. Complete the enrollment application online using the Medicare Provider Enrollment, Chain, and Ownership System (PECOS). You may want to review the resources below and/or the links on their site before completing the application. If you have not been to the site before, you will need to register and log in. PECOS shows you only the fields on the CMS-855a that you need to complete, so the online application is faster to complete and process than paper. The site is available 24 hours/day Monday - Saturday, and will send your completed application electronically to the Medicare Administrative Contractor (MAC) for your area.

Paper Option. If you can’t use PECOS, download and complete the 60-page CMS-855a form, Medicare Federal Health Care Provider/Supplier Enrollment Application, and mail it to your MAC. NOTE: Even though Medicare Part B covers dialysis, your MAC is the Part A MAC for your state. Your MAC will create a PECOS record with your application information. Your MAC can answer any questions you have about the CMS-855a form.

STEP 2: Contact your local State Survey Agency (SA) or the CMS-approved accreditation organization (AO). Download, complete, and send the CMS-3427 form, End Stage Renal Disease Application and Survey and Certification Report, to the SA or AO, which will tell you what other forms it needs (license, certificate of need, etc.).

To find your MAC and SA, visit the CMS Contacts database:

1. Choose your state.
2. For "Contact Type", choose "All contact types."
3. For "Contacts whose organization type is" choose:
   • "Fiscal Intermediary" (CMS now calls them MACs) or
   • ESRD State Survey Agency (SA)
4. Click the Show Contacts

STEP 3: CMS Locations (formerly “Regional Offices”) have historically processed ESRD enrollment applications. Starting in 2021 MACs will take on that function for ESRD facilities and will coordinate directly with the SA or the AO. After the MAC reviews and approves your CMS 855a, it will send it to the SA. AOs will ask you to provide the letter of approval from the MAC. CMS considers PD and home HD to be separate services.

• Applying for new certification? You will need an onsite initial survey, which should be done within 90 days of the date the MAC approves your application.
• Already certified and adding PD, home HD, or both? When the SA receives the form, the SA must schedule an onsite survey. The SA has no required timeline to do the onsite survey.

During the onsite survey, records for at least one patient and/or care partner in training or who was trained at your clinic will be reviewed for approval for PD, home HD, or both.

STEP 4: If the SA or AO determines that your clinic complies with the ESRD CfC, the Provider Enrollment Oversight Group (PEOG), which is under the Center for Program Integrity (CPI), is responsible for establishing a provider agreement with your clinic on behalf of CMS. Once the agreement is complete, your clinic will be assigned a CMS Certification Number (CCN; formerly a provider number), which allows your clinic to submit claims.  Claims to Medicare cannot be submitted for services you provided prior to the date your facility is approved for and has a CCN. You cannot bill for PD and/or home HD until CMS has approved your clinic for that service.

Nursing Home Dialysis

If you start to provide PD and/or home HD in one or more nursing homes, you must have an agreement with the nursing home. You must notify the SA of that agreement by submitting a new CMS 3427. If your clinic is CMS-certified through AO-accreditation of deemed status, send that form to your AO instead. Complete these fields:

• Field 1 – Type of application/notification: Choose Other #6
• Field 2 – Name of Dialysis Facility
• Field 3 – CCN
• Field 4 – Street Address
• Field 6 – City
• Field 7 – County
• Field 9 – State
• Field 10 – Zip Code
• Field 12 – Phone Number
• Field 22 – Does the dialysis clinic have any home patients who receive dialysis within long-term care (LTC) facilities? If so, provide nursing home names, addresses, CCNs, whether dialysis clinic or nursing home staff do the dialysis, and the number of PD and/or HD patients dialyzed in the nursing home.
• Field 26 – How is isolation provided?

At any initial or resurvey, the SA or AO will survey the dialysis service at the nursing home for compliance with the ESRD CfC.  If your clinic provides dialysis at multiple nursing homes, the SA or AO will survey a minimum of two nursing homes.

Conclusion

Applying for dialysis certification to include home dialysis training and support takes time, but is doable. There are in-person and online resources, including your MAC, SA, and/or AO. Offering individuals with kidney failure the option to do home dialysis can open doors for them to live longer, healthier, and more fulfilling lives.

Resources

• Conditions for Coverage for End-Stage Renal Disease Facilities; Final Rule
• Conditions for Coverage for End-Stage Renal Disease Facilities: Interpretive Guidance, Final Version 1.1 (10/3/2008)
• CMS State Operations Manual, Chapter 2 (Section 2280)
• CMS Medicare Learning Network, Medicare Provider Enrollment
• Completing the CMS-855a Before and After
• CMS Admin Memo: 18-15-ESRD—Initial Surveys of End Stage Renal Disease (ESRD) Facilities (2/20/2019)
• CMS S&C: 15-41—Surveyor Guidance for Approval of Home Dialysis Modalities (6/12/2015)