State Operations Manual (Pub. 100-07), Ch. 2 § 2016
Readmission to Medicare or Medicaid Program After Involuntary
2016 - Readmission to Medicare or Medicaid Program After Involuntary
Termination - Reasonable Assurance
(Rev. 1, 05-21-04)
(See also Chapter 7 for SNFs and NFs.)
2016A - Readmission Criteria
(Rev. 91, Issued: 09-27-13, Effective: 09-27-13, Implementation: 09-27-13)
After involuntary termination of a provider’s agreement, an institution cannot participate
in the Medicare or Medicaid program again unless:
The provider submits with its request for readmission sufficient justification to
indicate that the reasons for termination no longer exist; and
All of the applicable statutory and regulatory requirements are met; or
There is reasonable assurance for Medicare entities or Medicaid ICFs/IID
(terminated under §1910(b) of the Act by CMS) that the deficiencies that caused
the termination will not recur.
2016B - Reasonable Assurance Concept
(Rev. 91, Issued: 09-27-13, Effective: 09-27-13, Implementation: 09-27-13)
A Medicare provider terminated under 42 CFR 489.53 and reinstated under 42 CFR
489.57 or a Medicaid ICF/IID provider terminated pursuant to §1910(b)(1) of the Act is
required to operate for a certain period of time without recurrence of the deficiencies
which were the basis for the termination. The reasonable assurance concept also applies
to terminated Medicare suppliers such as ASCs (42 CFR 416.35(e)), FQHCs (42 CFR
405.2440), RHCs (42 CFR 405.2404(e)), and ESRD facilities (42 CFR 405.2180(c)).
The length of this “reasonable assurance” period is determined by the RO after an
evaluation of the provider or supplier’s previous compliance history. Reasonable
assurance periods are usually 30-120 days, but depending on the circumstances, can be for
a shorter or longer period of time. Participation can only resume following that period if
the provider or supplier has maintained compliance with program requirements.
The RO determines the reasonable assurance period for:
●
Medicare suppliers;
●
Medicare providers, including a SNF in a dually-participating facility,
terminated pursuant to §1866(b)(2) of the Act; and
●
ICFs/IID terminated by CMS pursuant to §1910(b)(1) of the Act.
In considering the decision to readmit a previously-terminated provider/supplier to the
Medicare or Medicaid program, the RO takes into account not only certification, but also
the intermediary’s statement concerning the institution’s financial responsibility and the
OCR’s report on compliance with civil rights requirements.
NOTE: There is no statutory or regulatory requirement that States must establish a
reasonable assurance period for Medicaid-only facilities or a NF in a dually-participating
facility that has been terminated by the SMA under §§1902(i) and 1919(h)(1) of the Act.
The reasonable assurance decision is an administrative action (not an initial determination)
and is not subject to the appeals process at 42 CFR Part 498.3(d)(5).
NOTE: These provisions do not apply where a termination action was the result of a
sanction imposed by the OIG. The RO forwards reinstatement requests involving these
provisions to the OIG for appropriate action.)
To determine the reasonable assurance period, the RO will evaluate the following:
1. Provider’s or Supplier’s Compliance History
When the provider/supplier previously participated in either Medicare or Medicaid
(ICF/IID), was compliance maintained historically?
Were PoCs implemented on time?
Does the provider/supplier have a history of making good faith efforts to correct
deficiencies and to maintain compliance?
Does it have a record of being cited repeatedly for essentially the same problems?
Were previous adverse actions initiated, but not put into effect?
2. Previous Adverse Action
Has the applicant/institution previously been terminated and readmitted to the Medicare
program? If yes:
How long was compliance maintained after being readmitted?
Have all deficiencies been corrected?
Are corrective actions permanent; i.e., is compliance likely to continue?
3. Other Factors Impacting Continued Compliance
Is the facility located in an area that is underserved by health professionals, meaning that
staffing deficiencies may continue?
Does the applicant’s pay scale or the facility’s location deter the hiring and retention of
staff?
Does it have inherent problems that are likely to cause recurrence of significant
deficiencies?
Has there been a change in staff or services furnished that might affect continued
compliance?
The following are examples using these criteria to determine reasonable assurance periods.
(See Chapter 7 for examples for SNFs/NFs.)
EXAMPLE A:
Green Acres Community Hospital was terminated on November 1, 1996. The provider
was cited as not meeting several CoPs. On December 1, 1996, the hospital board alleged
to have corrected all deficiencies the SA found. While reviewing the provider’s
compliance history, the RO notes that one or more CoPs were cited in previous surveys,
but the provider usually managed to achieve compliance just before termination.
Reasonable Assurance - The RO establishes 90 days from December 1, 1996, as
reasonable based on the provider’s history of not maintaining compliance.
EXAMPLE B:
Fox Chase General Hospital was terminated on December 21, 1996, for its failure to
maintain required staffing in nursing, dietary, and medical records. On January 2, 1997,
the provider alleged that he hired the necessary staff and requested readmission. Upon
review, the RO finds that the provider is located in a remote, under-served rural area and
has been unable to maintain staff since participation began in 1989.
Reasonable Assurance - The RO establishes 90 days from January 2, 1997, as reasonable
on the grounds that the location of the provider has militated against staff retention, and
that 3 months of continued compliance would evidence the provider’s ability to retain
qualified health professionals.
EXAMPLE C:
The XYZ Home Health Agency was terminated on September 15, 1997. On the four prior
surveys the agency had been cited for failure to meet several of the CoPs, but had, until
the most recent survey, achieved compliance before termination action was completed. On
October 1, 1997, the agency alleged compliance.
Reasonable Assurance - The RO establishes a 120-day reasonable assurance period
based on the provider’s repeated failure to meet the CoPs necessary to ensure the health
and safety of patients.
EXAMPLE D:
The Visiting Nurses, Inc., was readmitted following a 60-day reasonable assurance period.
On the next survey, The Visiting Nurses, Inc., is found not to meet one or more CoPs and
is again terminated. The provider corrects the deficiencies and requests readmission.
Reasonable Assurance - The RO establishes a 120-day waiting period based on prior
termination and failure to maintain compliance following a 2-month reasonable assurance
period.
EXAMPLE E
Pleasant Plains ICF/IID was terminated by CMS on January 10, 1996. The provider was
terminated for deficiencies that posed a threat to client health or safety. The provider
corrected its deficiencies and requested readmission on February 1, 1996. The SA
surveyed the facility on February 10, 1996, and determined that the deficiencies that were
the reason for the termination had been corrected and certified compliance. The
documentation was forwarded to the RO on February 21, 1996. While reviewing all
available documentation, the RO finds that the provider has a history of serious
deficiencies. Moreover, the deficiencies that led to termination have been cited
repeatedly.
Reasonable Assurance - The RO establishes a 180-day waiting period based on the
provider’s history of serious deficiencies and disregard for the health and safety of
patients.
2016C - Request for Readmission
(Rev. 1, 05-21-04)
A terminated provider or supplier may reapply for certification at any time. Upon receipt
of a request from an involuntarily terminated entity that desires readmission to the
program, the SA immediately contacts the entity and informs it of the requirements for
readmission. If the reasonable assurance time-period was not established at the time of
termination, the SA contacts the RO and requests that it establish the reasonable assurance
period so that it may be included in the letter to the facility informing it of the
requirements for readmission to the program. (The RO may choose to delay
establishment of the reasonable assurance period pending the results of the first
survey.) Use Exhibit 41 to inform the provider or supplier of the reasonable assurance
provisions and to transmit the required documents necessary for future participation. (See
the applicable initial certification section in Exhibit 63 for the required documents.)
If the institution then indicates that it meets the requirements for participation and returns
the initial application packet, forward the application packet to the RO via a Form CMS-
1539. The RO will contact the previous servicing intermediary. The intermediary, in
turn, advises the RO whether there are any outstanding financial problems, such as
overpayments, that need to be resolved before the institution is readmitted. In addition,
the RO takes immediate action to obtain title VI clearance.
2016D - Reasonable Assurance Surveys
(Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14)
Upon receipt of the initial application packet from the SA, the RO will provide the SA
with instructions concerning how to conduct the necessary reasonable assurance surveys.
Two surveys are required for Medicare certification to verify that the reason for
termination no longer exists, and that the provider/supplier has maintained continued
compliance. At least one of these surveys must be a full/standard survey to ensure that all
CoPs/CfCs are met or the SNF is in substantial compliance. The RO has the discretion to
determine whether both surveys will be full/standard surveys, or whether one may be a
partial survey to document compliance with requirements for which there were previous
deficiencies. If the RO decides that one survey will be a partial survey, the RO also
decides whether the partial survey will be the first or the second survey. (CMS, at its
discretion, conducts the survey for a ICF/IID it originally surveyed and terminated
pursuant to §1910(b)(1) of the Act.)
The reasonable assurance period of time begins on the date of completion of the first
survey documenting compliance with requirements for which there were prior
deficiencies.
The SA conducts the first of the reasonable assurance surveys as instructed by the RO and
submits the results of the survey (this may be submitted on Form CMS-2567) to the RO
within 10 working days of the survey. Based on the results of this first survey, the RO
determines if the reasons for termination no longer exist, or for SNFs, the deficiencies that
caused their termination are at the level of substantial compliance. The RO notifies the
SA and the provider/supplier of its determination. If the RO determines that the reasons
for termination no longer exist, or for SNFs that the deficiencies that caused the
termination are at the level of substantial compliance, the reasonable assurance period
begins effective with the last day of this first survey. If not, the provider must reapply.
Once the RO determines that the reasonable assurance period has begun, the SA will
schedule a second survey to coincide with the end of the reasonable assurance period.
The SA informs the RO of the scheduled survey date. The SA conducts the survey,
completes the Survey Report (as applicable), and prepares a statement to accompany Form
CMS-1539 that includes:
•
The finding that the deficiencies which led to termination of the provider
agreement have (or have not) been corrected;
•
The evidence showing that compliance has been maintained, and the reasons for
concluding that the deficiencies will not recur; and
•
A description of any other deficiencies and, if appropriate, an explanation as to
why the facility is nevertheless in compliance with all CoPs or the SNF is in
substantial compliance (see §§7203.B and 7300.C).
If the RO determines after the second survey that the reasons for termination continues to
exist and/or determines that the provider/supplier does not meet the CoPs or the SNF is
not in substantial compliance, the provider/supplier must again begin the reasonable
assurance process to gain reentry into the program(s). (See §§7203.B and 7300.C for the
exception for SNFs and NFs.)
If an involuntarily terminated provider/supplier attempts to re-enter the Medicare program
via deemed status accreditation under a CMS-approved Medicare accreditation program, it
must still satisfy the reasonable assurance requirements at 42 CFR 489.57. The RO has
the discretion to deny Medicare reentry based solely on deemed status accreditation
surveys and may instead require two surveys be performed by the SA if it is not
reasonably assured the provider/supplier meets the Medicare conditions. The RO also has
the discretion to accept an accreditation survey for either the first or second of the
reasonable assurance surveys. Generally an AO would not conduct both reasonable
assurance surveys, but if it is willing to do so and the RO is reasonably assured that the
provider/supplier meets the Medicare conditions, the RO may permit the AO to conduct
both reasonable assurance surveys.
In cases involving readmission of an involuntarily terminated provider seeking deemed
status, the RO will determine the IF (when it is reasonably assured that the reason for the
termination will not occur), the WHEN (the reinstatement effective date) and the HOW
(e.g., a survey by the SA) of the provider’s/supplier’s reentry into the Medicare program.
The RO will make an analysis of the facts in the case and issue a decision because
receiving deemed status is a separate issue from reinstatement (Reasonable Assurance)
following involuntary termination by CMS under 42 CFR 489.57.
The regulation at 42 CFR 489.57 does not apply to a provider’s voluntary termination of
its agreement under the provisions of the regulation at 42 CFR 489.52. In a scenario
similar to the situation described above except that the provider’s termination from
Medicare was voluntary, CMS (the RO) would still be responsible for the if, when and
how of the provider agreement under 42 CFR 489.12. However, the provider’s
accreditation by a recognized accrediting body and subsequent deemed status would mean
that compliance with the CoP would not be one of the unmet requirements under title
XVIII of the Act that could be invoked under 42 CFR 489.12(a)(3). This is pointed out
because some providers voluntarily withdraw from Medicare in the face of a proposed
involuntary termination. A RO could decide to process an involuntary termination in such
a case. In the absence of having processed an involuntary termination, the RO could apply
42 CFR 488.6(c)(2) in concert with 42 CFR 489.12(a)(3) in a case where a provider facing
involuntary termination voluntarily withdrew from Medicare and subsequently attempted
to re-enter the program through accreditation under a CMS-approved Medicare
accreditation program.
The regulation at 42 CFR 489.57 also does not apply to a provider’s initial application for
Medicare participation. Again, as with a voluntary termination, the CMS (RO) is
responsible for the if, when and how of the provider agreement and a decision to deny the
provider an agreement must be in accordance with 42 CFR 489.12. Also, if an accrediting
organization has determined that the provider is accredited, the provider is deemed to meet
the Medicare conditions and we would have satisfactory assurance of compliance with the
conditions under 42 CFR 489.12(a)(3). However, as with a voluntary termination, we
might look at 42 CFR 488.6(c)(2) in tandem with 42 CFR 489.12(a)(3) in an individual
case. This means that we should notify accrediting bodies if and when we deny a provider
entry into Medicare based on a State survey agency survey. This includes providers that
are surveyed by the State but do not respond to a Statement of Deficiencies.
2016E - Effective Date of Provider Agreement After Reasonable
Assurance
(Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14)
If the provider or supplier has maintained compliance throughout the reasonable assurance
period, it may reenter the program and be issued a new provider agreement or supplier
approval. The effective date of the new Medicare agreement and Medicaid FFP is
calculated based on the date of completion of the second reasonable assurance survey.
See Section 2008D for details on the calculation of the effective date.
2016F - Readmission of ICF/IID After Termination
(Rev. 91, Issued: 09-27-13, Effective: 09-27-13, Implementation: 09-27-13)
Before the SMA readmits an ICF/IID to the Medicaid program after termination by CMS
pursuant to §1910(b)(1) of the Act, the RO must determine that the facility has provided
the SA reasonable assurance that the deficiencies that were the cause for termination will
not recur. The RO will determine the reasonable assurance period, and the RO, or the SA,
at the RO’s request, will monitor the facility to determine that it remains in compliance for
the period of time designated by the RO as the reasonable assurance period. The SA or
the RO will monitor the facility by conducting the necessary survey and revisits.
The reasonable assurance period must be satisfied before the SMA issues an agreement to
that facility and before that facility can qualify for FFP. Failure to provide reasonable
assurance is a basis for CMS to continue to disallow FFP for services furnished by that
facility. (See 42 CFR Part 442.30 and 431.610(f)(1).)
2016G - Under LSC at Time of Readmission
(Rev. 1, 05-21-04)
1. Termination Based on LSC or Health Conditions
Upon readmission, an institution that was terminated for noncompliance with the LSC
must be surveyed under the edition of the Code in effect under current regulations.