Form CMS-3427 ESRD Application and Survey and Certification Report

DEPARTMENT OF HEALTH AND HUMAN SERVICES

FORM PENDING APPROVAL

CENTERS FOR MEDICARE & MEDICAID SERVICES

OMB NO. 0938-0360
PRA Disclosure Statement

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number for this information collection is 0938-0360 (Expires XX/XX/XXXX). The time required to complete this information collection is estimated to average 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 212441850. ****CMS Disclosure****Please do not send applications, claims, payments, medical records, or any documents containing sensitive information to the PRA Reports Clearance Office.
Please note that any correspondence not pertaining to the information collection burden approved under the associated OMB control number listed on this form will not be reviewed, forwarded, or
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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 [Item33]): (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

9. State

8. Fiscal Year End Date

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:
City:

Business Address:

_ State:

Zip Code:

Telephone No:

16. Ownership (V2) ☐1. For Profit ☐2. Not for Profit ☐3. Public
17. Is this dialysis facility independent (i.e., not owned or managed by a hospital)? (V3)☐1. Yes ☐2. No
Is this dialysis facility owned and managed by a hospital and on the hospital campus (i.e., hospital- based)? (V4) ☐1. Yes ☐2. No
Is this dialysis facility owned and managed by a hospital and located off the hospital campus (i.e., satellite)? (V5)☐1. Yes ☐2. No
18. Is this dialysis facility located in a SNF/NF (LTC) (check one): (V6) ☐1. Yes ☐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)
☐3. In-center Nocturnal HD

☐4. Home HD Training & Support ☐5. HD in LTC

☐6. Home PD Training & Support ☐7. PD in LTC ☐8. Dialyzer Reuse
21. New modalities/services being requested (check all that apply; must have 1 permanent patient for any modality requested): (V14)

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FORM CMS-3427

☐1. In-center HD ☐2. In-center PD ☐3. In-center Nocturnal HD
☐4. Home HD Training & Support ☐5. HD in LTC
☐6. Home PD Training & Support ☐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? (V15)
☐1. Yes ☐2. No
LTC (SNF/NF) facility name: (V16)

_ CCN: (V17)

Staffing for home dialysis in LTC provided by: (V18)
☐1. This dialysis facility ☐2. LTC staff ☐3. Other, specify:
Number of dialysis residents by modality receiving dialysis within this LTC facility: (V19)
☐1. HD

☐2. PD

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) ☐1. Yes ☐2. N/A
25. Additional in-center stations requested: (V28)

or

☐ None

26. How is isolation provided? (V29) ☐1. Room ☐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

Last in-center shift ends or home only facility closes: M

T

W

Th

F

Sat

Sun
Sun

29. Dialyzer reprocessing: (V32) ☐1. Onsite ☐2. Centralized/Offsite ☐3. N/A
30. Staff (List full-time equivalents):
Registered Nurse: (V33)
LPN/LVN: (V35)

Certified Patient Care Technician: (V34)
Technical Staff (water, machine): (V36)

Registered Dietitian: (V37)
Others: (V39)

Masters Social Worker: (V38)

____________________________________________

31. State license number (if applicable): (V40)
32. Certificate of Need required? (V41)

☐1. Yes ☐2. No ☐3. NA

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

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FORM CMS-3427

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 ☐3. Relocation ☐ 4. Expansion/change of services ☐ 5. Change of ownership
☐6. Complaint ☐7. Revisit ☐8. Other, specify_
37. State Region: (V44)

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)

41. Name/Number (print)

42. Professional Discipline (print)

43. Survey Exit Date

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FORM CMS-3427

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 home 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). Notifications of any agreement initiated between the facility and a LTC facility for providing home dialysis to residents within any LTC facility require completion of
Item 22 (and 33 if applicable) and submission of this form to the State agency . You must answer Yes (Item 22) and have at least one LTC dialysis resident for addition of services for home
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.

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FORM CMS-3427