CMS-10279 Supporting Statement Part A _ 508 compliant

Supporting Statement for the Paperwork Reduction Act Submission,
Medicare and Medicaid Programs: Conditions for Coverage for Ambulatory Surgical
Centers and supporting regulations in 42 CFR 416
A.

Background
The purpose of this package is to request Office of Management and Budget (OMB) approval
of the collection of information requirements for the conditions for coverage (CfCs) that
ambulatory surgical centers (ASCs) must meet to participate in the Medicare program). The
burden associated with a separate and current ASC information collection is currently
approved under OMB No. 0938-0266, with an expiration date of September 30, 2014. With
this submission, we are requesting to reinstate this supplemental PRA package for ambulatory
surgical centers (ASCs).
The requirements in the ASC regulations establish the development of the disaster
preparedness plan, quality assessment and performance improvement plan development and
collection, analysis, documentation of the findings, and the development of a patient rights
informational sheet and related documentation requirements of alleged violations or
complaints and the disclosure statements to the appropriate personnel.
The ambulatory surgical center conditions for coverage (CfCs) were originally published on
August 5, 1982, and, for the most part, these regulations have remained unchanged since that
time. To take advantage of the continuing advances in the health care delivery field, be more
in alignment with today’s ASC health care industry standards, and incorporate
recommendations made by various government agencies, we’ve revised the CfCs.
The reinstatement is an on-going information collection package that resulted from the
publication of the ASC conditions for coverage final rule on November 18, 2008. The ASC
CfCs focus on a patient-centered, outcome-oriented, and transparent process that promotes
quality patient care. The final rule contained both new provisions and provisions that were
carried over from the previous version of the ASCs.
This submission captures information necessary to support the implementation of the CfCs for
5,300 ASCs.
This document represents the ASC CfCs that are effective in the final rule published on
November 18, 2008.

B.

Justification

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1. Need and Legal Basis
Section 934 of the Omnibus Budget Reconciliation Act of 1980, which is implemented under
42 CFR 416, allows ASCs meeting health, safety, and other standards specified by the
Secretary to participate in Medicare. Section 934 amended various sections of the Social
Security Act, including sections 1832 and 1863 which instruct the Secretary to consult with
appropriate State Agencies and recognize national listing or accreditation bodies in developing
the conditions (health and safety requirements), and section 1864, which authorizes the
Secretary to use States in determining compliance with the requirements, referred to in
regulations as CfCs.
The CfCs are designed to ensure that each facility has properly trained staff to provide the
appropriate type and level of care for that facility and provide a safe physical environment for
patients.
2.

Information Users
The CfCs are used by Federal or State surveyors as a basis for determining whether an ASC
qualifies for approval or re-approval under Medicare. CMS and the healthcare industry
believe that the availability to the facility of the type of records and general content of records,
which this regulation specifies, is standard medical practice and is necessary in order to ensure
the well-being and safety of patients and professional treatment accountability.

3.

Use of Information Technology
ASCs may use various information technologies to store and manage patient medical records
as long as they are consistent with the existing confidentiality in record-keeping regulations at
42 CFR 485.638. This regulation in no way prescribes how the facility should prepare or
maintain these records. Facilities are free to take advantage of any technological advances that
they find appropriate for their needs.

4.

Duplication of Efforts
These requirements are specified in ways that do not require an ASC to duplicate efforts. If an
ASC already maintains these general records, regardless of format, they are in compliance
with this requirement. The general nature of these requirements makes variations in the
substance and format of these records from one ASC to another acceptable.

5.

Small Businesses
These requirements will not have a significant impact on ASCs and other suppliers that are
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small entities. Further, most of the requirements in this rule are part of ASCs’ standard
practices. We understand that there are different sizes of ASCs and that the burden for ASCs
of different sizes will vary.
6.

Less Frequent Collection
CMS does not collect information directly from ASCs. In most cases, the rule does not
prescribe the manner, timing, or frequency of the records or information that must be
available. ASC records are reviewed at the time of a survey for initial or continued
participation in the Medicare program. Less frequent information collection would impede
efforts to establish compliance with the Medicare CfCs.

7.

Special Circumstances
There are no special circumstances.

8.

Federal Register/Outside Consultation
The 60-day Federal Register notice was published on May 31, 2013.

9.

Payments/Gifts to Respondents
There will be no payments/gifts to respondents.

10. Confidentiality
Confidentiality will be maintained to the extent provided by law. We pledge confidentiality
of patient-specific data in accordance with the Privacy Act of 1974 (5 U.S.C. 552a).
11. Sensitive Questions
There are no questions of a sensitive nature associated with this information collection.

12. Burden Estimates (Hours & Wages)
ASSUMPTIONS AND ESTIMATES USED THROUGHOUT THE IMPACT ANALYSIS SECTION
# of Medicare ambulatory surgical centers nationwide
# of patients per ASC (average)
Hourly rate of registered nurse
Hourly rate of administrator
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5,300
1265
$32.66
$47.34

Salary data is based on the salary website at www.bls.gov and apply to the following
personnel:
“Administrator” refers to the administrator who runs the day to day operation of the ASC, and
who, according to www.bls.gov has a median annual income of $98,460. Thus, the hourly
rate used in this report is $47.34 (i.e., $98,460 divided by 52 weeks per year divided by 40
hours per week).
“Registered nurse” refers to the registered nurse who runs the day to day operation of an ASC,
and who, according to www.bls.gov has a national median salary of $67,930. Thus, the hourly
rate used in this report is $32.66 (i.e., $67,930 divided by 52 weeks per year divided by 40
hours per week).
§416.41(c)(1) Standard: Disaster preparedness plan.
The ASC must maintain a written disaster preparedness plan that provides for the emergency
care of patients, staff and others in the facility in the event that fire, natural disaster, functional
failure of equipment, or other unexpected events or circumstances are likely to threaten the
health and safety of those in the ASC. We estimate the burden associated is the time and effort
necessary to draft and maintain the written disaster preparedness plan. In addition, there is
burden associated with drafting and maintaining the reports on the effectiveness of the plan.
We estimate that an administrator, earning $47.34 per hour, would be largely responsible for
developing the plan and for managing the yearly drills and evaluations. We estimate that the
yearly cost for one ASC to develop, implement and maintain a disaster preparedness plan will
be approximately 4 hours at $47.34 per hour, with a net cost of $189.36 per ASC (4 hours x
$47.34). The total annual burden cost for all ASCs is estimated to be $1,003,608 ($189.36 x
5300 ASCs).
GOVERNING BODY AND MANAGEMENT BURDEN ASSESSMENT
Standard
Disaster preparedness plan

Time per ASC
(hours)
4

Total time
(hours)
21,200

Cost per
ASC
$189.36

Total cost
$1,003,608

§416.43 Quality assessment and performance improvement.
(d. Standard: Performance improvement projects.)
An ASC must develop, implement, and maintain an effective, ongoing, data-driven quality
assessment and performance improvement (QAPI) program. In addition, the ASC must
maintain documentary evidence of its quality assessment and performance improvement
program. The QAPI program must be able to demonstrate measurable improvement in
indicators related to improved health outcomes and by the identification and reduction of
medical errors. An ASC must use all relevant quality indicator data to design its QAPI
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program, monitor the effectiveness and safety of services and quality of care, identify, and
prioritize improvement opportunities. An ASC must track adverse patient events, analyze
their causes, and implement preventative actions and mechanisms that include feedback and
learning throughout the ASC. An ASC must measure its success and track performance in its
performance improvement initiatives to ensure that the improvements are continuous.
The burden associated with the requirements contained in §416.43 is the time and effort
necessary to develop, draft, and implement a QAPI program. As part of implementing the
QAPI program, an ASC must record quality data for performance improvement initiatives.
We estimate that it will take 12 hours for each ASC to develop its own quality assessment
performance improvement program. We also estimate that each ASC would spend 18 hours a
year collecting, analyzing and documenting the projects that are being conducted. The ASC
must document, at a minimum, the reason for implementing the project, and a description of
the project’s results. Both the program development and the improvement projects would
most likely be managed by the ASC’s administrator. Based on an hourly rate of $47.34, the
total burden associated with these requirements per ASC is $1,420 (30 hours x $47.34). The
total annual burden cost for the ASC industry is $7,526,000 ($1,420 x 5300 ASCs)
QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT BURDEN
ASSESSMENT
Standard
Developing QAPI
Collecting/analyzing/documenting
findings
Annual total

Time per ASC
(hours)
12
18

Total time
(hours)
63,600
95,400

Cost per
ASC
$568
$852

Total cost
$3,010,400
$4,515,600

30

159,000

$1,420

$7,526,000

§416.50(a)(1) Standard: Notice of rights and responsibilities
An ASC must provide the patient or the patient’s representative with written and verbal notice
of the patient’s rights prior to the start of the surgical procedure and, in a language and manner
that the patient or the patient’s representative understands. The ASC must post the written
notice of patient rights in a place or places within the ASC likely to be noticed by patients (or
their representative, if applicable) waiting for treatment. The ASC’s notice of rights must
include the name, address, and telephone number of a representative in the State agency to
whom patients can report complaints, as well as the website for the Office of the Medicare
Beneficiary Ombudsman. The ASC must also disclose, where applicable, physician financial
interests or ownership in the ASC facility in accordance with the intent of Part 420 of this
subchapter. Disclosure of information must be in writing. The burden associated with this
notification requirement is the time and effort necessary for an ASC to develop the
notification form, to provide both verbally and in writing the patient or the patient’s
representative a notice of patient’s rights where applicable, disclosure of physician financial
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interests or ownership in the ASC facility and distribute information pertaining to its policies
on patient rights.. There are 5,300 ASCs that must comply with the aforementioned
requirements. We estimate that an ASC will utilize a registered nurse to develop the patient
right form. We estimate that it will take one hour on a one-time basis for an ASC to develop
the form. The total one time burden hours for the industry are 5,300 (1 hours x 5,300 ASCs).
At the average hourly rate of $32.66 for a registered nurse, it will cost an ASC $32.66 to meet
this requirement. The total one time burden cost for the industry is $173,098.
§416.50 (a)(3) Standard: Submission and investigation of grievances.
An ASC is required to establish a grievance procedure for documenting the existence,
submission, investigation and disposition of a patient’s written or verbal grievance. The ASC
must document all alleged violations/grievances relating, but not limited to, mistreatment,
neglect, verbal, mental, sexual, or physical abuse. All allegations must be immediately
reported to a person in authority in the ASC and only substantiated allegations must be
reported to the State authority or the local authority, or both. The ASC must also take action
to correct problems once they are identified. The burden associated with the recordkeeping
and reporting requirements described in §416.50(a)(3) is the time and effort necessary to fully
document the alleged violation or complaint, disclose the written notice to each patient who
filed a grievance, and report the alleged violations to the aforementioned entities. We
estimate that in a one year period an ASC would need to conduct investigational sessions for
alleged violations involving about 1% (12) of its patients. On average we estimate that, it will
take each ASC registered nurse15 minutes at a cost of $32.66 an hour to develop and
disseminate 12 notices on an annual basis (15 minutes x 12 patients = 3 hours per ASC), for a
total annual ASC burden of 15,900 hours (3 hours x 5300 ASCs) at a cost of $519,294
($32.66 x 15,900 hours).
PATIENT RIGHTS BURDEN ASSESSMENT
Standard
Develop form
Documentation of
grievances
Totals

Time per Total time
ASC
(hours)
(hours)
1
5,300

Cost per
average
ASC
$32.66

Total cost
$173,098

3

15,900

$98

$519,400

4

21,200

$130

$692,498

13. Capital Costs
There are no additional capital costs.

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14. Cost to Federal Government
There are minimal costs associated with these requirements that are accrued at the Federal
level and especially at the regional office (RO) levels. For example, RO staff is responsible for
acting on the information collections requirements discussed in this package as it relates to
ASC compliance. Once state survey agencies have completed their surveys and if a final
decision to terminate an ASC for noncompliance is to be made, such decisions are made by
the Central Office and the RO.
15. Changes to Burden
Changes to the burden are a reflection of the increase in number of Medicare certified ASCs at
this time compared to the previous collection and the changes in current average hourly rate
for medical professionals used in the calculations.
16. Publication/Tabulation Dates
We do not plan to publish any of the information collected.
17. Expiration Date
This collection does not lend itself to the displaying of an expiration date because data
collection and forms are used on a continual basis

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