Statement of Deficiencies and
Plan of Correction (CMS-2567)
Revision of a currently approved collection
No
Emergency
08/23/2021
07/13/2021
Requested
Previously Approved
6 Months From Approved
05/31/2023
65,948
64,500
1,210,376
139,750
0
0
This Paperwork package provides
information regarding the form used by the Medicare, Medicaid, and
the Clinical Laboratory Improvement Amendments (CLIA) programs to
document a health care facility's compliance or noncompliance
(deficiencies) with regard to the Medicare/Medicaid Conditions of
Participation and Coverage, the requirements for participation for
Skilled Nursing Facilities and Nursing Facilities, and for
certification under CLIA. This form becomes the evidentiary basis
for CMS certification decisions (including termination or denial of
participation), and the form of public disclosure. In December,
2020, Congress passed the Consolidated Appropriations Act, 2021
(CAA, 2021). Section 407 of CAA, 2021, amended Part A of Title
XVIII of the Social Security Act (the Act) at section 1822
establishing hospice program survey and enforcement requirements.
This amendment, in part, now requires the Accrediting Organizations
(AOs) that accredit hospice programs to include the form CMS-2567
to document the findings of their hospice program surveys beginning
on October 1, 2021. As of June 2021, there are three AOs with
CMS-approved hospice accreditation programs: Accreditation
Commission for Health Care, Inc. (ACHC), Community Health
Accreditation Partner (CHAP), and The Joint Commission (TJC). These
three AOs survey approximately half of the over 5,000
Medicare-certified hospice programs, while the SAs survey the
remaining half. To enable AOs to use the form CMS-2567, we must
revise it by adding a field for the AO name. Also, the instructions
must be updated to include AOs as another group which utilizes the
form CMS-2567. We have also included the COI/RIA burden
calculations from CMS-1747-P related to the one-time update needed
to each AO’s proprietary electronic systems in order to use the
form CMS-2567 as directed by the CAA, 2021.
The Consolidated
Appropriations Act of 2021 (CAA, 20211), passed on January 15,
2020, amends Title XVIII of the Social Security Act (Act), by
adding nine provisions that establish survey and enforcement
requirements for hospice programs. These statutory revisions became
public law through Congress on December 27, 2020. The provisions of
the CAA begin one year after its enactment, except for the
following: (1) the requirement for use of multidisciplinary survey
teams; (2) the prohibition of conflicts of interest; (3) expanding
CMS-based surveyor training to accrediting organizations (AOs); and
(4) the requirement for AOs to begin use of the form CMS-2567.
These four (4) requirements are statutorily required to begin on
October 1, 2021.2 In order for AOs that accredit hospice programs
to use form CMS-2567, the form must first be revised and approved
by OMB. The revisions are to include a data field in which to
document the name of the AO completing the survey. This is critical
information that must be included on the form CMS-2567 in order for
the CMS locations and CMS central office to identify which AO
performed the survey, or be able to distinguish an AO survey from a
survey performed by the State Survey Agency (SA), as they also use
the form CMS-2567 to document their survey findings. The use of
normal PRA clearance procedures would most likely cause CMS to miss
the statutorily mandated deadline of October 1, 2021 for AOs, with
a hospice program, to begin using the form CMS-2567. Without
emergency PRA approval, AOs will not have the revised form to
include in their current survey documentation systems and processes
and will not meet the deadline of October 1, 2021 for beginning
use. If CMS misses the October 1, 2021 deadline, it will jeopardize
another CAA, 2021 mandated provision deadline for public posting of
these AO hospice program survey reports on our website. The purpose
of this requirement is for public transparency of survey and
certification information. This statutory provision requires that
the hospice program survey reports be posted by no later than
October 1, 2022. Emergency PRA approval is critical for AOs and CMS
to meet our congressionally mandated responsibilities.
US Code:
42
USC 488.28 Name of Law: Providers or Suppliers, other than SNFs
and NFs, with deficiencies
US Code: 42
USC 488.18 Name of Law: Documentation Findings
US Code: 42
USC 488.26 Name of Law: Determining Compliance
The total number of responses
has increased by 1,448. The total annual time burden has increased
by 1,070,626 hours and the total annual cost burden has increased
by $81,550,156. These increases are due to the reasons discussed
below. First, in the previous PRA package for form CMS-2567,
grossly underestimated the time and cost burden because it did not
consider the burdens required to perform surveys. Second, due to
the statutory changes brought on by the CAA, 2021 - AOs with
hospice programs must begin use of the form CMS-2567 not later than
October 1, 2021. Therefore, we have included additional users and a
one-time systems update time/cost burden. It is important to note
that the time and cost burden associated with hospice program AOs
incorporation of the form CMS-2567 into their electronic
documentation systems is a one-time burden and not annually.
Finally, we have updated the wage rates used in the burden
calculations to the most current wage rates produced by the U.S.
Bureau of Labor Statistics. For example, the hourly wage for a
Medical or Health Services Manager went from $100.22 to $110.74.
This is an increase of $10.52 per hour and contributed to the
increased cost burden.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
Form CMS-2567 Statement of Deficiencies and Plan of Correction
CMS-2567 Emergency Justification SIGNED.pdf
CMS-2567 Supporting Statement clean 6-16-21.docx
Statement of Deficiencies and Plan of Correction