Form CMS-3427 ESRD Application and Survey and Certification Report

DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES

FORM PENDING APPROVAL
OMB NO. 0938-0360

PRA Disclosure Statement

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number
for this information collection is 0938-0360. The time required to complete this information collection is estimated to average of 20 minutes per response, including the time to review instructions,
search existing data resources, gather the data needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate(s) or suggestions
for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C4-26-05, Baltimore, Maryland 21244-1850.

END STAGE RENAL DISEASE APPLICATION AND SURVEY AND CERTIFICATION REPORT
PART I – APPLICATION – TO BE COMPLETED BY FACILITY
1. Type of Application/Notification (check all that apply; if “Other,” specify in “Remarks” section [Item 33]): (V1)
1. Initial

2. Recertification

3. Relocation

4. Expansion/change of services

5. Change of ownership

6. Other, specify
2. Name of Dialysis Facility_________________________________________________

3. CCN______________________________

4. Street Address________________________________________________________

5. NPI________________________________

6. City_________________________________

7. County_____________________

8. Fiscal Year End Date__________________

9. State________________________________

10. Zip Code:__________________

11. Administrator’s Email Address
_____________________________________

12. Telephone No._______________________

13. Facsimile No._______________

14. Medicare Enrollment (CMS 855A)
completed?
Yes
No
NA

15. Dialysis Facility Administrator Name:______________________________________________________________________________
Business Address:_____________________________________________________________________________________________
City:________________________________________ State:________ Zip Code:_________ Telephone No:_____________________
16. Ownership (V2)

1. For Profit

2. Not for Profit

3. Public
1. Yes

17. Is this dialysis facility independent (i.e., not owned or managed by a hospital)? (V3)

2. No

Is this dialysis facility owned and managed by a hospital and on the hospital campus (i.e., hospital-based)? (V4)
Is this dialysis facility owned and managed by a hospital and located off the hospital campus (i.e., satellite)? (V5)
18. Is this dialysis facility located in a SNF/NF (LTC) (check one): (V6)

1. Yes

1. Yes

2. No

1. Yes

2. No

2. No

If SNF/NF owned and managed by a hospital: hospital name: (V7)_______________________________________________________ CCN: (V8)_________
If Yes, SNF/NF name: (V9)_________________________________________________________ CCN: (V10)______________________________
19. Is this dialysis facility owned &/or managed by a multi-facility organization? (V11)

1. No

2. Yes, Owned

3. Yes, Managed

If Yes, name of multi-facility organization: (V12)_______________________________________________________________________
Multi-facility organization’s address:_______________________________________________________________________________
20. Current modalities/services for dialysis facilities requesting recertification only (check all that apply): (V13)
1. In-center Hemodialysis (HD)

2. In-center Peritoneal Dialysis (PD)

4. Home HD Training & Support

5. HD in LTC

6. Home PD Training & Support

7. PD in LTC

3. In-center Nocturnal HD

8. Dialyzer Reuse

21. New modalities/services being requested (check all that apply; must have 1 permanent patient for any modality requested): (V14)
1. In-center HD

2. In-center PD

4. Home HD Training & Support
6. Home PD Training & Support

3. In-center Nocturnal HD
5. HD in LTC
7. PD in LTC

8. Dialyzer Reuse

9. N/A

NOTE: For dialysis in more than 1 LTC facility, record this same information in the “Remarks” (item 33) section or attach list
22. Does the dialysis facility have any dialysis (PD/HD) patients physically receiving dialysis within long-term care (LTC) facilities?
1. Yes

Staffing for home dialysis in LTC provided by:

(V18)

1. This dialysis facility

2. LTC staff

Number of dialysis residents by modality receiving dialysis within this LTC facility: (V19)
FORM CMS-3427

(V15)

2. No LTC (SNF/NF) facility name: (V16)__________________________________________________________ CCN: (V17)_____________
3. Other, specify:________________

1. HD______

2. PD______
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END STAGE RENAL DISEASE APPLICATION AND SURVEY AND CERTIFICATION REPORT
23. Number of dialysis patients currently on census:
In-Center HD: (V20) ____ In-Center Nocturnal HD: (V21) ____ In-Center PD: (V22) ____
Home PD: (V23) ____ Home HD <= 3x/week: (V24) ____ Home HD >3x/week: (V25) ____
24. Number of currently approved in-center dialysis stations: (V26) ___ Are onsite home training room(s) provided? (V27)
25. Additional in-center stations requested: (V28) ____ or
26. How is isolation provided? (V29)

1. Room

1. Yes

2. N/A

None

2. Area (existing 2/9/2009 only)

3. CMS Waiver/Agreement (Attach copy)

27. If applicable, number of hemodialysis stations designated for isolation: (V30)________
28. Days/times for in-center shifts or operating hours if home only (check all days that apply and complete time field in military time): (V31)
1st in-center shift starts or home only facility opens: M________ T________ W________ Th________ F________ Sat________ Sun__________
Last in-center shift ends or home only facility closes: M________ T________ W________ Th________ F________ Sat________ Sun__________
29. Dialyzer reprocessing: (V32)

1. Onsite

2. Centralized/Offsite

3. N/A

30. Staff (List full-time equivalents): Registered Nurse: (V33)__________ Certified Patient Care Technician: (V34) __________
LPN/LVN: (V35) __________ Technical Staff (water, machine): (V36) __________
Registered Dietitian: (V37) __________ Masters Social Worker: (V38) __________
Others: (V39)_____________________________________________________________________________________________________
31. State license number (if applicable):

32. Certificate of Need required? (V41)

(V40)_______________

1. Yes

2. No

3. NA

33. Remarks (copy if more and attach additional pages if needed):

34. The information contained in this Application Survey and Certification Report (Part I) is true and correct to the best of my knowledge. I
understand that incorrect or erroneous statements may cause the request for approval to be denied, or facility approval to be rescinded,
under 42 C.F.R. 494.1 and 488.604 respectively.
I have reviewed this form and it is accurate:
Signature of Administrator/Medical Director

Title

Date

______________________________________________

________________________________

______________________

PART II TO BE COMPLETED BY STATE AGENCY
35. Medicare Enrollment (CMS 855A recommended for approval by the Medicare Administrative Contractor)? (V42)

1. Yes

2. No

(Note: approved CMS 855A required prior to certification)
36. Type of Survey: (V43)

1. Initial

2. Recertification

5. Change of ownership

3. Relocation

6. Complaint

37. State Region: (V44)__________________________________

4. Expansion/change of services

7. Revisit

8. Other, specify__________________________

38. State County Code: (V45) _______________________________

39. Network Number: (V46)_______________________________________________________________________________________________________________________________
My signature below indicates that I have reviewed this form and it is complete.
40. Surveyor Team Leader (sign)
_____________________________
FORM CMS-3427

41. Name/Number (print)
__________________________

42. Professional Discipline (Print)
__________________________

43. Survey Exit Date
___________________:
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END STAGE RENAL DISEASE APPLICATION AND SURVEY AND CERTIFICATION REPORT
INSTRUCTIONS FOR FORM CMS-3427
PART I – DOCUMENTATION NEEDED TO PROCESS FACILITY APPLICATION/NOTIFICATION TO BE COMPLETED BY
APPLICANT
A completed request for approval as a supplier of End Stage Renal Disease (ESRD) services in the Medicare program (Part I – Form
CMS-3427) must include a copy of the Certificate of Need approval, if such approval is required by the state.

TYPE OF APPLICATION (ITEM 1)
Check appropriate category. A “change of service” refers to an addition or deletion of services, e.g. home dialysis, dialysis in LTC, dialyzer
reuse, in-center nocturnal HD, in-center PD, etc. “Expansion” refers to addition of in-center stations. If you relocate one of your services to a
different physical location, you may be required to obtain a separate CCN for that service at the new location.

IDENTIFYING INFORMATION (ITEMS 2-19)
Enter the name and address (actual physical location) of the dialysis facility where the services are performed. If the mailing address is
different, show the mailing address in Remarks (Item 33). Check the applicable blocks (Item 17 and Item 18) to indicate the dialysis facility’s
hospital and/or SNF/NF affiliation, if any. If so, enter the CCN of the hospital and/or SNF/NF. Check whether the dialysis facility is owned
and/or managed by a “multi-facility” organization (Item 19) and provide the name and address of the parent organization. A “multi-facility
organization” is defined as a corporation or a LLC that owns more than one dialysis facility.

TYPES OF MODALITIES/SERVICES, DIALYSIS STATIONS, AND DAYS/HOURSOF OPERATION (ITEMS 20-29)
Check the modalities/services that are already offered (“current modalities/services”) by a dialysis facility requesting recertification (Item 20).
Check N/A or check each NEW modality/service for which you are requesting approval. Any new modality/service must be requested on the
CMS-3427 and filed with the State agency. At the time of survey, one permanent patient must be on the dialysis facility’s census in-center
or in training/trained by the facility for each modality requested (Item 21). Note that dialysis facilities providing home therapies must provide
both training and support. If you are requesting to offer home training and support only (Item 21), you must have a functional
plan/arrangement to provide backup dialysis as needed. If you request any home training and support program (Item 21), you must also
indicate “Yes” for a training room (only count stations for in-center dialysis, not for home training) (Item 24). If you currently provide or
support dialysis within one or more LTC facilities (SNF/NF), complete Item 22 and list for all LTCs: name, CCN, staffing provided
by, and number of dialysis patients treated by modality under Remarks (Item 33). New requests for dialysis within any LTC facility
require completion of Item 22 (and 33 if applicable) and submission of this form to the State agency prior to survey. You must
answer Yes (Item 22) and have at least one LTC dialysis resident for addition of services for dialysis in LTC. Enter the number of additional
in-center stations for which you are asking approval (Item 25). Provide information on isolation (Items 26-27). Dialysis facilities not existing
prior to October 14, 2008 which do not have an isolation room must attach evidence of CMS waiver and written agreement with
geographically proximal facility with isolation room. Provide current information on all days and start time for the first shift and end time for
the last shift of in-center patients (in military time) for each day of operation. If the dialysis facility offers home training and support only,
provide current operating hours for each day (Item 28). Provide information on dialyzer reprocessing (Item 29).

STAFFING (ITEM 30)
“Other” includes non-certified patient care technicians, administrative personnel, etc. To calculate the number of full-time equivalents of any
discipline (Item 30), add the total number of hours that all members of that discipline work at this dialysis facility and enter that number in
the numerator. Enter into the denominator the number of hours that facility policy defines as full-time work for that discipline. Report FTEs in
0.25 increments only. Example: An RD works 20 hours a week at Facility A. Facility A defines full time work as 40 hours/week. To calculate
FTEs for the RD, divide 20 by 40. The RD works 0.50 FTE at Facility A.

LICENSING AND CERTIFICATE OF NEED, IF APPLICABLE (Items 31-32)
If your state requires licensing for ESRD facilities, include your current license number in Item 31. If your state requires a Certificate of Need
(CON) for an initial ESRD or for the change you are requesting, mark the applicable box in Item 32 and include a copy of the documentation
of the CON approval.

REMARKS (ITEM 33)
You may use this block for explanatory statements related to Items 1-32.
The administrator/medical director signs and dates. Upon completion, forward a copy of form CMS-3427 (Part I) to the State
agency.

PART II - TO BE COMPLETED BY STATE AGENCY
The surveyor should review and verify the information in Part I with administrator or medical director and complete Part II of this form.
Recognize that CMS cannot issue a CCN for an initial survey until all required steps are complete, including recommended approval of the
CMS-855A by the applicable MAC. Complete the Statement of Deficiencies (CMS Form 2567) in ASPEN. Complete the CMS-1539 in
ASPEN entering recommended action(s). All required information must be entered in ASPEN and uploaded in order for the survey to be
counted in the state workload.

FORM CMS-3427

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