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pdfRevisions to Form CMS-3427 – End Stage Renal Disease Application and Survey and Certification Report
Issue #
1.
Page #
All
Section
Each Page
Action to be performed
Revise as follows
Changes to the Application
Add the draft watermark and removing the date from the
footer on each page; renumber answers for ASPEN
programming as indicated
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 09380360. 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.
Name of Dialysis Facility
2.
1
Heading
Revise to add the PRA
Disclosure Statement as
follows
3.
1
Part 1
#2-Revise as follows with
addition in red text
4.
1
Part 1
#15- Revise as follows with
additions in red text.
Dialysis Facility Administrator Name
Business Address
5.
1
Part 1
#17- Reword, reorder,
delete to revise as follows
with additions in red text
with “not” underlined, and
deletions in strikethroughs
6.
1
Part 1
#18- Revise as follows with
additions in red text
Is this dialysis facility independent (i.e., not owned or
managed by a hospital)?
Is this dialysis facility owned and managed by a hospital and
on the hospital campus (i.e., hospital-based)?
Is this dialysis facility owned and managed by a hospital and
located off the hospital campus (i.e., satellite)?
Is this facility no owned or managed by a hospital (i.e.,
independent)?
If owned and managed by a hospital: hospital name____CCN_
Is this dialysis facility located in a SNF/NF (LTC) (check one)
If SNF/NF owned and managed by a hospital: hospital
name:______ CCN:_____
If Yes, SNF/NF name:______ CCN:_____
Reason for the Change
Revising the application; therefore, this date
will change and draft watermark is needed
for posting.
OMB requires the PRA Disclosure
Statement to be on all CMS forms.
Revised for clarification purposes.
“Dialysis” clarifies the type of
facility applying for ESRD
certification because this form also
asks for information about other
facility types (hospitals, nursing
homes, etc.)
Revised for clarification purposes. As above
“Dialysis” clarifies the type of facility
applying for ESRD certification. Applicants
are to report their business address instead of
their residential address.
Revised for clarification purposes and
underlined “not” in response to comment
received from dialysis provider. Deleted
hospital name and CCN because the
information is not necessary since ESRD
facility must use its own CCN even if
hospital-based or satellite.
Revised for clarification purposes. If the
dialysis facility is located in or provides or
supports dialysis in NF/SNF (LTC), the
name of the LTC is collected in #22 and
1
Issue #
Page #
Section
Action to be performed
Changes to the Application
Is this dialysis facility owned &/or managed by a multi-facility
organization? Yes, Managed
If Yes, name of multi-facility organization______
Multi-facility organization’s address______
Current modalities/services for dialysis facilities requesting
recertification only (check all that apply):
1. In-center Hemodialysis (HD)
2. In-center Peritoneal
3. In-center Nocturnal HD 4.
Reuse 5
Dialysis (PD)
Home HD Training & Support
5. HD in LTC
6. Home
7. PD in LTC Home Training &
PD Training & Support
Support only
8. Dialyzer Reuse
7.
1
Part 1
#19- Revise as follows with
addition in red text
8.
1
Part 1
#20- Revise as follows with
additions in red text
9.
1
Part 1
#21- Revise as follows with
additions in red text and
deletions in strikethrough.
New modalities/services being requested (check all that apply;
must have 1 permanent patient for any modality requested):
1. In-center HDN/A
2.In-center PD
3. In-center
Nocturnal HD 5. Reuse
4. Home HD Training & Support
5. HD in LTC
6. Home PD Training & Support
7.
8. Dialyzer Reuse Home Training & Support
PD in LTC
only
9. N/A
10.
1
Part 1
#22- Revise as follows to
move the note first and
added text in red and
deletions in strikethroughs
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 home dialysis (PD/HD)
patients physically receiving dialysis inwithin long-term care
(LTC) facilities?
Yes
No
LTC (SNF/NF) facility name:_____ CCN:_____
Staffing for home dialysis in LTC provided by:
1. This
2. LTC staff
3. Other, specify
dialysis facility
TypeNumber of dialysis residents by modality receiving
dialysis provided inwithin this LTC facility:
1. HD
2.
PD
Reason for the Change
instructions say to list additional LTCs in
Remarks (#33).
Revised for clarification purposes.
“Dialysis” clarifies the type of facility
applying for ESRD certification
Revised for clarification purposes in
question and instructions. Only currently
certified facilities requesting recertification
should complete this question. This change
addressed a comment received from a
dialysis provider indicating confusion about
whether a new facility would include
modalities and services it intends to offer as
“current.” Added modality because reuse
and home training & support are services.
All other options are dialysis modalities.
Deleted “home training & support only”
because a facility providing only home HD
or only home PD should mark only the
option(s) it provides.
Revised for clarification purposes in
question and instructions to comply with the
2008 ESRD Conditions for Coverage that
require 1 permanent patient for any modality
requested. Added modality because reuse
and home training & support are services.
All other options are dialysis modalities.
Deleted “home training & support only”
because a facility providing only home HD
or only home PD should mark only the
option(s) it provides.
Revised for clarification purposes in the
question and instructions to avoid confusion
among applicants who have patients who do
dialysis within the LTC facility instead of in
the patient’s private home.
Added the number of dialysis residents by
modality for each LTC facility to be able to
help the ESRD surveyor know the patient
census of dialysis treatments offered within
the LTC facility.
2
Issue #
Page #
Section
Action to be performed
Changes to the Application
For additional LTC facilities, record this information and
attach to the “Remarks” (Item 33) section
Number of currently approved in-center dialysis stations:____
Are Oonsite home training room(s) provided?
1. Yes
2. N/A
11.
1
Part 1
#24- Revise as follows with
additions in red text; now on
page 2
12.
1
Part 1
Additional stations being requested
None
In-center HD
In-center nocturnal HD
13.
2
Part 1
#25-Revise as follows with
deletions in strikethrough;
now on page 2
#26-Revise as follows with
additions in red text
14.
2
Part 1
#28-Revise as follows with
additions in red text and
deletions in strikethrough
15.
2
Part II
#35 Revise as follows with
additions in red text and
deletions in strikethrough
16.
3
Instructions for
Form CMS
3427
Revise 1st paragraph in
instructions as follows with
deletion in strikethrough
and addition in red text
17.
3
Instructions for
Form CMS
3427
Revise as follows deleting
strikethrough and adding
red text
Days &/times for in-center patient shifts or operating hours if
home only (check all days that apply and complete time field
in military time):
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____
Medicare Enrollment (CMS 855A approved recommended for
approval by the MAC/FI Medicare Administrative Contractor)
1. Yes
2. No
(Note: approved CMS 855A required prior to certification)
PART 1 – 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 narrative statement describing the need for the
service(s) to be provided, and
Aa 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.
In-center PD
How is isolation provided?
1. Room
2. Area
(established facilities existing 2/9/2009 only)
3. CMS
Waiver/Agreement (Attach copy)
Reason for the Change
Revised for clarification purposes and to
address comment received from a dialysis
provider to indicate the station count is only
for in-center dialysis and that home training
room(s) are only reported as Yes or No.
Revised for clarification purposes and to
address comment received from a dialysis
provider.
Revised for clarification purposes to comply
with the 2008 ESRD Conditions for
Coverage. Survey & Certification
Memorandum 09-13 states as of 2/9/09, new
facilities must have an isolation room or
waiver.
Revised to clarify facility operating hours for
facilities that only provide home dialysis and
to state patient in-center shifts start and end.
Revised to conform to the instructions in the
CMS 855A, page 3.
Revised to eliminate duplication since the
narrative is included in Certificate of Need
approval, if applicable.
Revised for clarification purposes.
3
Issue #
18.
19.
Page #
3
Section
Instructions for
Form CMS
3427
Action to be performed
Revise as follows in red
text.
Instructions for
Form CMS
3427
Revise as follows with
deletions in strikethrough
and additions in red text
Changes to the Application
IDENTIFYING INFORMATION (ITEMS 2-2419)
Enter the name and address (actual physical location) of the
ESRD 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 20-2829)
Provide information on currentCheck the modalities/services
that are already offered (“current modalities/services”) by a
dialysis facility requesting recertification (Item 20). Check
N/A or check each NewNEW 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, and
address) participating in this services staffing provided by,
and number of dialysis patients treated by modality under
Remarks (Item 33) and complete Item 22. 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 incenter 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
Reason for the Change
Revised for clarification purposes and to
correct Item numbers in the Identifying
Information section.
Revised for clarification purposes to address
comment from provider that described
confusion about how to complete these
questions on the Form CMS-3427. Bolded
text to draw greater attention to changes.
4
Issue #
Page #
Section
Action to be performed
20.
3
Under Staffing,
revise as
follows
Revise as follows with
addition in red text.
21.
3
Under
REMARKS
22.
3
Under Licensing
and Certificate
of Need
23.
3
Part II
Move this section before
Licensing and Certificate of
Need and revise as follows
with additions in red text.
Move this section after
REMARKS and revise as
follows with additions in red
text.
Revise as follows with
additions in red text and
deletions in strikethrough
Changes to the Application
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 of patients 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 fulltime 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.
Add: “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 the form
CMS-3427 (Part I) to the State agency.
LICENSING AND CERTIFICARE OF NEED, IF
APPLICABLE (Items 31-32)’
PART II - SURVEY AND CERTIFICATION REPORT
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 approved 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.
Reason for the Change
Revised for clarification purposes.
Revised for clarification purposes and to
indicate who at the facility must sign and
date to attest that the information on the
Form CMS-3427 is accurate.
Revised for clarification purposes to indicate
that Certificate of Need may not be
applicable and to add the Item numbers for
this section
Revised for clarification purposes and to
conform to the instructions for the CMS855A.
5
File Type | application/pdf |
File Title | Revised CMS 3427 Change Table |
Author | CMS |
File Modified | 2016-02-15 |
File Created | 2016-02-15 |