State Operations Manual (Pub. 100-07), Ch. 5 § 5110.3
Condition-Level, Non-IJ
5110.3 - Condition-Level, Non-IJ
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
If the provider/supplier fails to demonstrate substantial compliance, i.e., condition-level
deficiencies are identified by the SA, but they do not pose an IJ, the SA certifies its
findings to the CMS location via ACTS within 10 working days after the survey
completion date.
The CMS location reviews the SA’s findings, and if it concurs with the SA’s
recommendation, the CMS location either places the deemed provider/supplier on a 90
calendar-day termination track or it requires a full survey after a complaint survey.
In determining whether to exercise its discretion to require a full survey for deemed
providers and suppliers, the CMS location may consider factors including, but not limited
to, the following:
• The manner and degree of noncompliance identified as a result of the complaint
investigation;
• The provider’s/supplier’s compliance history;
• Recent changes in the provider’s/supplier’s ownership or management;
• The length of time since the provider’s/supplier’s last accreditation survey;
• The availability of SA resources at the time required to conduct a full survey;
and/or
• The advantages associated with conducting a more extensive survey compared to
the advantages associated with the faster enforcement (and thus a faster potential
corrective action) that result when proceeding directly to enforcement action after
the complaint survey.
Paragraph a) below discusses the procedures when the CMS location does not
require a full survey after the complaint survey; paragraph b) discusses the
procedures to follow when the CMS location directs the SA to conduct a full survey.
a) No full survey – proceed directly to termination track based on the complaint
survey
If the CMS location places the deemed provider/supplier on a 90 calendar-day
termination track as a result of the complaint investigation, it sends the
provider/supplier the Form CMS 2567, notifies the provider/supplier of the proposed
termination action and effective date, which will be 90 calendar days after the date of
the CMS location’s notice. The CMS location requests submission of an acceptable
plan of correction to the SA within 10 calendar days. The notice also contains a
statement that “removes” the “deemed status” of the provider/supplier and places it
under SA jurisdiction.
The CMS location sends a copy of the notice to the SA and a copy of the notice and
Form CMS 2567 to the applicable AO(s). At the CMS location’s discretion, the
materials may be sent to the AO via e-mail.
NOTE: Although deemed status has technically been “removed” and the
provider/supplier is placed under SA jurisdiction, because it is expected that deemed
status will be restored once corrections are made and verified, no change is made in
ASPEN to the provider’s/supplier’s deemed status. However, periods during which
the provider/supplier is under SA jurisdiction are entered and tracked in ASPEN.
Further, the AO may also conduct a survey of the facility so long as it continues to
accredit the provider/supplier.
The SA conducts a complaint survey revisit after the SA has received a timely and
acceptable plan of correction, but no later than the 45th calendar day after the notice
to the provider/supplier.
1) No Timely, Acceptable Plan of Correction Submitted
If the provider/supplier fails to submit a timely and acceptable plan of correction
to the SA and as a result the SA is unable to conduct a timely revisit before the
termination date, the SA notifies the CMS location and the CMS location may
proceed with termination. See SOM Section 3254F. The CMS location publishes
a public notice 15 days prior to the termination date. The CMS location notifies
the applicable Medicare Administrative Contractor (MAC) via the Form CMS
2007 of the termination of the provider/supplier’s Medicare agreement, including
the effective date of the termination.
The CMS location approves the complaint investigation Form CMS 562 and other
applicable items in ACTS and then, depending on CMS location practice, either
the SA or CMS location uploads the complaint survey package into the CMS
National Reporting System (CASPER). The provider’s or supplier’s Medicare
agreement is terminated in ASPEN.
Additionally, the CMS location sends a copy of the notice of termination letter to
the applicable AO(s).
2) First Revisit Survey Findings: Substantial Compliance
The termination action is rescinded if substantial compliance (i.e., no condition-
level deficiencies) is achieved and documented through the onsite verification at
the first revisit survey. There may or may not be standard-level deficiencies cited.
Within 10 working days after the completion of the revisit survey, the SA certifies
to the CMS location in ACTS its findings and recommends that the termination
action be rescinded.
The CMS location randomly selects several Form CMS 2567s with standard-level
deficiencies for review to determine if the CMS location concurs with the SA’s
finding of substantial compliance.
• For all cases not selected for review of the Form CMS 2567, the CMS location
completes the processing in ACTS of the complaint investigation Form CMS
562 and other applicable items in ACTS, and then, depending on CMS
location practice, either the SA or CMS location uploads the complaint survey
package into CASPER, the CMS National Reporting System.
• For cases selected for review of the Form CMS 2567:
• If the CMS location concurs with the finding, the CMS location
completes the processing in ACTS of the complaint investigation
Form CMS 562 and other applicable items in ACTS, and then,
depending on CMS location practice, either the SA or CMS location
uploads the complaint survey package into CASPER, the CMS
National Reporting System.
• If the CMS location does not concur with the SA’s findings of
substantial compliance, the CMS location discusses with the SA any
revisions needed on the Form CMS 2567 and, after the revisions are
made, follows the procedures for a survey finding substantial
noncompliance. (See Section 5110.2 or 5110.3, as applicable.)
The CMS location either issues a notice, or authorizes the SA in ACTS to issue a
notice to the provider/supplier of its compliance status and that its deemed status
is restored. The CMS location or SA, as applicable, issues this notice to the
provider/supplier, along with a copy of the Form CMS 2567 with the survey
findings.
The CMS location sends a copy of the notice and Form CMS 2567 to the
applicable AO(s). At the CMS location’s discretion, the materials may be sent to
the AO via e-mail.
3) First Revisit Survey Findings: Substantial Noncompliance
If the SA finds during the first revisit survey that the provider/supplier is not in
substantial compliance with one or more Medicare conditions, the SA consults
with the CMS location on its findings and whether to conduct a second revisit. If
the CMS location agrees that condition-level deficiencies remain, the CMS
location considers whether the survey findings warrant a second revisit or
proceeding immediately to termination. Generally the CMS location authorizes a
second revisit, but the CMS location has discretion to make an exception, based
on the facts of the situation. For example, if the SA and CMS location determine
that an immediate jeopardy was present during the first revisit, the CMS location
might find it prudent to proceed to termination without a second revisit.
If the CMS location agrees that condition-level deficiencies remain and does not
authorize a second revisit, the CMS location and SA follow the procedures
outlined in paragraph 3ii. below.
If a second revisit is authorized by the CMS location, the SA sends the
provider/supplier the Form CMS 2567 for the first revisit with notice that
substantial noncompliance remains, the 90-day termination date remains in effect,
a new acceptable plan of correction is required, and that an additional revisit will
be conducted prior to the termination date. The SA conducts the second revisit no
later than 60 calendar days after the date of the termination notice.
i.
Second Revisit Survey Findings: Substantial Compliance
If substantial compliance is achieved by the provider/supplier (i.e., no
condition-level deficiencies are identified through the on-site verification by
the SA), the SA certifies its findings to the CMS location via ACTS within 10
working days after the survey completion date, and recommends that the
termination action be rescinded.
The CMS location randomly selects some Form CMS 2567s with only
standard-level deficiencies for review, to determine if the CMS location
concurs with the SA’s finding of substantial compliance. If the CMS location
concurs, and in all other cases where the Form CMS 2567 is not reviewed by
the CMS location, CMS location completes the processing in ACTS of the
complaint investigation Form CMS 562 and other applicable items in ACTS
and then, depending on CMS location practice, either the SA or CMS location
uploads the complaint survey package into CASPER, the CMS National
Reporting System. If the CMS location does not concur, the CMS location
discusses with the SA revisions needed on the Form CMS 2567 and, after the
revisions are made, follows the procedures for substantial noncompliance.
The CMS location either issues a notice, or authorizes the SA in ACTS to
issue the provider/supplier a notice letter of its compliance status and that its
deemed status is restored. The CMS location or SA, as applicable, forwards
this notice to the provider/supplier, along with a copy of the Form CMS 2567
with the survey findings.
Additionally, the CMS location sends a copy of the notice and the Form CMS
2567 to the applicable AO(s). At the CMS location’s discretion, the materials
may be sent to the AO via e-mail.
ii.
Second Revisit Survey Findings – Substantial Noncompliance
If the second revisit survey shows that the provider/supplier fails to
demonstrate substantial compliance (i.e., condition-level deficiencies are
identified through on-site verification by the SA), the SA certifies its findings
to the CMS location via ACTS within 10 calendar days after the survey
completion date, and recommends that the termination action proceed.
The CMS location reviews the SA’s findings, and if it concurs with the SA’s
recommendation, the CMS location sends the provider/supplier a final
termination letter and publishes a public notice at least 15 calendar days prior
to the termination date, consistent with the requirements of Section 3012. The
provider/supplier is terminated from the Medicare program. The CMS
location notifies the applicable Medicare Administrative Contractor (MAC)
via the Form CMS 2007 of the termination of the provider/supplier’s
Medicare agreement, including the effective date of the termination.
The CMS location completes the processing in ACTS of the complaint
investigation Form CMS 562 and other applicable items in ACTS and then,
depending on CMS location practice, either the SA or CMS location uploads
the complaint survey package into CASPER, the CMS National Reporting
System. The provider’s or supplier’s Medicare agreement is terminated in
ASPEN.
Additionally, the CMS location sends a copy of the termination notice and the
Form CMS 2567 to the applicable AO(s). At the CMS location’s discretion,
the materials may be sent to the AO via e-mail.
b) Full Survey After the Complaint Survey
If the CMS location directs the SA to conduct a full survey following the complaint
survey, it sends the Form CMS 2567 for the complaint survey to the provider/supplier
in addition to a notice letter indicating that it is “removing” the provider’s/supplier’s
deemed status and that a full survey will be conducted on an unannounced basis.
The provider/supplier is not required to submit a plan of correction in response to the
complaint survey findings, but may choose to do so.
The CMS location completes the processing in ACTS of the complaint investigation
Form CMS 562 and other applicable items in ACTS and then, depending on CMS
location practice, either the SA or CMS location uploads the complaint survey
package into CASPER, the CMS National Reporting System.
Additionally, the CMS location sends a copy of the notice letter and Form CMS 2567
for the complaint survey to the applicable AO(s). At the CMS location’s discretion,
the materials may be sent to the AO via e-mail.
NOTE: Although deemed status technically has been removed and the
provider/supplier is placed under SA jurisdiction, because it is expected that deemed
status will be restored once corrections are made and verified, no change is made in
ASPEN to the provider’s/supplier’s deemed status. However, periods during which
the provider/supplier is under SA jurisdiction are entered and tracked in ASPEN.
Further, the AO may also conduct a survey of the facility so long as, since it
continues to accredit the provider/supplier.
The full survey must be conducted within 60 calendar days after the CMS
location’s notice to the provider/supplier of the complaint survey results and
removal of deemed status. The CMS location and SA follow the procedures in
Section 5110.4.