Medicare and Medicaid Programs; Ambulatory Surgical Centers, Conditions for Coverage, 50470-50487 [07-4148]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 72, Number 169 (Friday, August 31, 2007)]
[Proposed Rules]
[Pages 50470-50487]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-4148]



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Part II





Department of Health and Human Services





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Centers for Medicare & Medicaid Services



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42 CFR Part 416



Medicare and Medicaid Programs; Ambulatory Surgical Centers, Conditions 
for Coverage; Proposed Rule

Federal Register / Vol. 72, No. 169 / Friday, August 31, 2007 / 
Proposed Rules

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 416

[CMS-3887-P]
RIN 0938-AL80


Medicare and Medicaid Programs; Ambulatory Surgical Centers, 
Conditions for Coverage

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Proposed rule.

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SUMMARY: This proposed rule would revise some of the existing 
conditions for coverage (CfCs) that ambulatory surgical centers must 
meet to participate in the Medicare and Medicaid programs. The proposed 
modifications are intended to update the existing CfCs to reflect 
current practice and set forth new requirements to promote and protect 
patient health and safety.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on October 30, 2007.

ADDRESSES: In commenting, please refer to file code CMS-3887-P. Because 
of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways (no duplicates, 
please):
    1. Electronically. You may submit electronic comments on specific 
issues in this regulation to https://www.cms.hhs.gov/eRulemaking. Click 
on the link ``Submit electronic comments on CMS regulations with an 
open comment period.'' (Attachments should be in Microsoft Word, 
WordPerfect, or Excel; however, we prefer Microsoft Word.)
    2. By regular mail. You may mail written comments (one original and 
two copies) to the following address ONLY: Centers for Medicare & 
Medicaid Services, Department of Health and Human Services, Attention: 
CMS-3887-P, P.O. Box 8017, Baltimore, MD 21244-8017.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments (one 
original and two copies) to the following address ONLY: Centers for 
Medicare & Medicaid Services, Department of Health and Human Services, 
Attention: CMS-3887-P, Mail Stop C4-26-05, 7500 Security Boulevard, 
Baltimore, MD 21244-1850.
    4. By hand or courier. If you prefer, you may deliver (by hand or 
courier) your written comments (one original and two copies) before the 
close of the comment period to one of the following addresses. If you 
intend to deliver your comments to the Baltimore address, please call 
telephone number (410) 786-7195 in advance to schedule your arrival 
with one of our staff members. Room 445-G, Hubert H. Humphrey Building, 
200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    (Because access to the interior of the HHH Building is not readily 
available to persons without Federal Government identification, 
commenters are encouraged to leave their comments in the CMS drop slots 
located in the main lobby of the building. A stamp-in clock is 
available for persons wishing to retain a proof of filing by stamping 
in and retaining an extra copy of the comments being filed.)
    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and received after the comment 
period.
    Submission of comments on paperwork requirements. You may submit 
comments on this document's paperwork requirements by mailing your 
comments to the addresses provided at the end of the ``Collection of 
Information Requirements'' section in this document.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: 

Jacqueline Morgan, (410) 786-4282.
Joan A. Brooks, (410) 786-5526.
Steve Miller, (410) 786-6656.
Rachael Weinstein, (410) 786-6775.

SUPPLEMENTARY INFORMATION:
    Submitting Comments: We welcome comments from the public on all 
issues set forth in this rule to assist us in fully considering issues 
and developing policies. You can assist us by referencing the file code 
CMS-3887-P and the specific ``issue identifier'' that precedes the 
section on which you choose to comment.
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following Web 
site as soon as possible after they have been received: https://
www.cms.hhs.gov/eRulemaking. Click on the link ``Electronic Comments on 
CMS Regulations'' on that Web site to view public comments.
    Comments received timely will also be available for public 
inspection as they are received, generally beginning approximately 3 
weeks after publication of a document, at the headquarters of the 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 
a.m. to 4 p.m. To schedule an appointment to view public comments, 
phone 1-800-743-3951.

I. Background

    [If you choose to comment on issues in this section, please include 
the caption ``BACKGROUND'' at the beginning of your comments.]
    As the single largest payer for health care services in the United 
States, the Federal Government assumes a critical responsibility for 
the quality of care furnished under its programs. Historically, the 
Medicare program's quality assurance approach was focused on 
identifying health care entities that furnish poor quality care or that 
fail to meet minimum Federal standards. Overall, we have found that 
this problem-focused approach has had inherent limitations and does not 
necessarily translate into better care for patients. Ensuring quality 
through the enforcement of prescriptive health and safety standards 
alone has resulted in expending many of our resources on working with 
marginal providers, rather than stimulating broad-based improvements in 
quality of care.
    Section 1832(a)(2)(F)(i) of the Social Security Act (the Act) 
specifies that an ASC must meet health, safety, and other requirements 
specified by the Secretary of Health and Human Services (HHS) (the 
Secretary) in regulation if it has an agreement in effect with the 
Secretary. Under the agreement, the ASC agrees to accept the standard 
overhead amount determined under section 1833(i)(2)(A) of the Act as 
full payment for services, and to accept an assignment described in 
section 1842(b)(3)(B)(ii) of the Act for payment for all services 
furnished by the ASC to enrolled individuals. The Secretary is 
responsible for ensuring that the CfCs and their enforcement are 
adequate to protect the health and safety of individuals treated by 
ASCs.
    To implement the CfCs, we determine compliance through State survey 
agencies that conduct onsite inspections utilizing these requirements. 
ASCs may be deemed to meet Medicare standards if they are certified by 
one of the national accrediting organizations whose standards meet or 
exceed the

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CfCs. Currently, there are four Medicare approved national 
accreditation organizations: The Joint Commission; American Association 
for Accreditation of Ambulatory Surgical Facilities (AAAASF); 
Accreditation Association for Ambulatory Health Care (AAAHC); and the 
American Osteopathic Association (AOA).
    The current ASC CfCs were originally published on August 5, 1982 
(47 FR 34082), and, for the most part, these regulations have remained 
unchanged since that time. From 1990 to 2000, the number of ASCs 
participating in the Medicare program has increased at a rate of about 
175 facilities a year. The total number of ASCs more than doubled from 
1,197 to 2,966 during this ten year period, making ASCs one of the 
fastest growing facility types in the Medicare program. The annual 
volume of procedures performed on both Medicare and non-Medicare 
patients have also tripled. Currently, over 4,600 ASCs participate in 
the Medicare program.\1\ This growth is due in part to advances in 
medical technology that have produced additional surgical procedures 
that can be safely performed outside of a hospital setting and 
increased focus on patient health and safety and patient convenience. 
This shift has paved the way for increasing numbers of procedures to be 
performed in an ASC. We believe that the changes we are proposing will 
strengthen and modernize the CfCs to be more aligned with today's ASC 
health care industry standards.
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    \1\ Only comprehensive rehabilitation facilities and rural 
health clinics have experienced a higher rate of growth. Office of 
Evaluations and Inspections (OEI) analysis of Part B Medicare data. 
See Office of Inspector General Quality Oversight of Ambulatory 
Surgical Centers Supplemental Report 1: The Role of Certification 
and Accreditation.
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    In addition, the recent transparency initiative directed by 
President Bush requires that more data be made available to all 
Americans as part of the Administration's commitment to make health 
care more affordable and accessible. In support of this initiative, we 
announced in August 2006 the release of Medicare payment information 
for 61 procedures performed in ASCs. The new information is available 
on our Web site at https://www.cms.hhs.gov/HealthCareConInit/ and will 
help patients undergoing surgical procedures select the most 
appropriate setting for the delivery of high quality, efficient care. 
The information will show ``Commonly Performed Procedures in ASCs,'' 
and will contain charge and Medicare payment data for ASC facility 
costs for a limited number of services administered in States and 
counties. The data is broken down at the county, State and national 
level. Moreover, the CMS Web site at https://www.cms.hhs.gov/center/
ombudsman.asp is available to the public and ASC patients to get 
information about the Medicare and Medicaid programs, prescription drug 
coverage, and how to coordinate Medicare benefits with other health 
insurance programs. The Web site also includes information about filing 
a grievance or complaint.
    Section 109 of Division B, Title I of the Tax Relief and Health 
Care Act of 2006 (Pub. L. 109-432) (TRHCA), Quality reporting for 
hospital outpatient services and ambulatory surgical center services, 
requires that the Secretary develop measures that are appropriate to 
determine the measurement of quality care (including medication errors) 
furnished by ASCs that reflect the consensus among affected parties. 
These measures, to the extent feasible and practicable, shall include 
measures set forth by one or more national consensus building entities. 
The Secretary is authorized to reduce the annual payment update for 
failure to report on the chosen quality measures. We expect Medicare 
beneficiaries to receive high quality surgical services and for that 
reason, we are proposing to include a Quality Assurance Performance 
Improvement Requirement (QAPI) as a new condition for coverage (Sec.  
416.43). (See section II.B.2 of the preamble of this proposed rule for 
a more detailed discussion of the quality assurance improvement 
requirement.)
    We are soliciting public comments on quality measures appropriate 
to ASCs. We are interested in public comments regarding the extent to 
which ASCs are currently utilizing quality measures, the data source 
for those measures (for example, claims data and chart abstraction), 
and the extent to which those data are maintained electronically. We 
are also interested in how the measures were developed and why they are 
appropriate to measure the care provided to Medicare patients in ASCS.
    We have developed a patients' right condition that emphasizes an 
ASC's responsibility to respect and promote the rights of each ASC 
patient.

II. Provisions of the Proposed Regulation

    [If you choose to comment on issues in this section, please include 
the caption ``PROVISIONS'' at the beginning of your comments.]
    Eliciting quality health care for Federal beneficiaries from CMS-
certified providers and suppliers requires taking advantage of 
continuing advances in the health care delivery field. As a result, we 
are revising the Medicare ASC requirements to focus on a patient-
centered, outcome-oriented process that promotes patient care foremost, 
rather than a prescriptive, inflexible approach that penalizes 
providers of substandard care.
    The conditions for coverage (CfCs) for ambulatory surgical centers 
(ASCs) were originally issued in 1982. Most of the revisions made since 
then have been payment related. Since 1982, significant innovations in 
ASC patient care delivery and quality assessment practices have 
emerged. In an effort to ensure continued quality in the ASC setting, 
we are proposing to revise three of the existing conditions and create 
three new conditions. The proposed revised conditions are: Governing 
body and management; Evaluation of quality (renamed Quality Assessment 
and Performance Improvement (QAPI); and Laboratory and radiologic 
services. The proposed new conditions are: Patient rights; Infection 
control; and Patient admission, assessment and discharge. Our objective 
is to achieve a balanced regulatory approach by ensuring that an ASC 
furnishes health care that meets essential health and quality 
standards, while ensuring that it monitors and improves its own 
performance.
    To achieve this objective, we are working to revise not only the 
ASC requirements but the requirements for other major health care 
provider types, such as hospitals, home health agencies and end-stage 
renal disease facilities, through separate rules. All of the revised 
and new requirements are directed towards improving patient outcomes of 
care and satisfaction.

A. Definitions (Sec.  416.2)

    Existing Sec.  416.2 sets forth definitions for terms used in the 
ASC CfCs. We are proposing to revise the definition of ``Ambulatory 
surgical center (ASC).'' Also, we are proposing to add the definition 
for ``overnight stay.''
    The ASC definition would read as follows:
    Ambulatory surgical center or ASC would mean any distinct entity 
that operates exclusively for the purpose of providing surgical 
services to patients not requiring an overnight stay following the 
surgical services, has an agreement with CMS to participate in Medicare 
as an ASC, and meets the conditions set forth in subparts B and C of 
this part.
    The overnight stay definition would read as follows:
    Overnight stay, for purposes of the ASC CfCs, would mean the 
patient's

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recovery requires active monitoring by qualified medical personnel, 
regardless of whether it is provided in the ASC, beyond 11:59 p.m. of 
the day on which the surgical procedure was performed.
    To provide further clarification on the overnight stay definition, 
we are proposing to use the 11:59 p.m. threshold as the standard for 
determining a patient's status when receiving services in an ASC 
facility. In the Medicare cost reporting manual (Provider Reimbursement 
Manual, Part 1, Section 2205 (Medicare Patient Days, page 22-16)), we 
have defined a hospital inpatient day as beginning at midnight and 
ending 24 hours later. Consistent with this longstanding policy, we 
would codify in regulations that any patient whose recovery requires 
active monitoring by qualified personnel beyond 11:59 p.m. of the day 
on which the surgical procedure was performed, is a patient who may 
require hospitalization or more intensive care. Accordingly, ASCs that 
are Medicare-certified may not keep patients beyond 11:59 p.m. of the 
day on which the surgical procedure was performed.
    The Medicare Hospital Outpatient Prospective Payment System and CY 
2007 Payment Rates proposed and final rules (71 FR 49506 and 71 FR 
67960) address the denial of payment of an ASC facility fee for any 
procedure for which prevailing medical practice dictates that the 
beneficiary will typically be expected to require active medical 
monitoring and care at midnight following the procedure. We also note 
that the patient's location at midnight is a generally accepted 
standard for determining his or her status as a hospital inpatient or 
skilled nursing facility patient and as such, it is reasonable to apply 
the same standard in the ASC setting.

B. Specific Conditions for Coverage

    We are proposing to retain many current requirements because they 
still reflect current practice and are predictive of ensuring desired 
outcomes and preventing harmful outcomes.
    The changes we are proposing to the current CfCs are the result of 
three main considerations.
    First, we considered the suggestions put forth in a February 2002 
report by the HHS Office of Inspector General (OIG) entitled, Quality 
Oversight of Ambulatory Surgical Centers; A System in Neglect [Janet 
Rehnquist, Inspector General, OEI-01-00-00450]. The report provided two 
recommendations specifically related to ASC patient health and safety. 
It recommended updating the CfCs to include patient rights and quality 
improvement. It also recommended that the CfCs be written in a manner 
that takes into consideration the scope and severity of the different 
types of surgical procedures, thereby establishing varied sets of 
requirements to which ASCs would be accountable.
    In response to the suggestions in the OIG report, we are proposing 
to replace the current Evaluation of Quality requirement with a new 
QAPI requirement and are proposing to add a new Patient Rights 
requirement. However, from both a policy perspective and an operational 
perspective, we are unable to propose different sets of ASC CfCs that 
are based on the scope of severity of the procedures offered by an ASC. 
Since ASCs are free to host a wide range of surgical procedures, 
enforcement of a variety of sets of requirements based on the type of 
procedures provided would be difficult to implement, since this would 
demand changes in the type and frequency of State agency oversight. In 
addition, ASCs wishing to upgrade their certification (if the 
regulations were approached as a tiered system) would require 
recertification and add additional oversight burden to the State 
agencies. This would continue to impact available resources. However, 
we would expect each ASC's QAPI program to reflect the scope and 
severity of the surgical services they perform.
    Second, we received feedback from the various ASC stakeholders that 
attended a 1996 Town Hall meeting sponsored by CMS. Recommendations 
were overwhelmingly directed toward payment issues, updating CPT codes, 
coverage of specific procedures, and reclassification of the procedure 
codes. However, a number of the commenters did favor incorporating a 
QAPI program in place of the existing requirement at Sec.  416.43 
(Evaluation of quality) since most ASCs had already implemented a 
quality assurance performance improvement program as the standard of 
practice.
    Third, this proposed rule is part of a larger CMS effort to bring 
about improvements in the quality of care furnished to Medicare and 
Medicaid beneficiaries through an outcome-oriented approach. The 
existing ASC CfCs do not, in any practical manner, address patient 
rights or a way to incorporate a quality assessment program that will 
assist ASCs in managing patient care more effectively. Accordingly, in 
light of such concerns, we would revise the CfCs to include a QAPI 
program and patient rights requirement.
1. Condition for Coverage--Governing Body and Management (Sec.  416.41)
    The current regulation contains a condition for Governing Body and 
Management. We are proposing new language in the condition statement 
which would require the governing body to assume direct oversight and 
accountability for the QAPI program. The governing body would be 
responsible for ensuring that QAPI efforts, at a minimum, focus on 
identifying areas needing improvement and that QAPI is implemented in 
accordance with Sec.  416.43 of this part. Specific governing body QAPI 
responsibilities are detailed in the proposed QAPI requirement at Sec.  
416.43. By focusing on QAPI, ASC management would be expected to be 
better able to improve care being furnished to patients. We are also 
proposing that the governing body be responsible for creating and 
maintaining a disaster preparedness plan. In addition, we are proposing 
to retain the current requirement which provides that the ASC can 
contract for services with an outside resource. However, we propose to 
incorporate this language into a separate standard, located at Sec.  
416.41(a). The ASC's governing body would still be responsible for the 
services that are furnished.
    The standard on hospitalization will remain the same but has been 
separated into two subparts for purposes of State agency survey 
findings. This would enable State surveyors to cite an ASC's compliance 
with these requirements more precisely. All ASCs will still be required 
to transfer patients requiring emergency medical care beyond the 
capabilities of the ASC to the nearest local, Medicare-participating 
hospital or a local, non-participating hospital that meets the 
requirements for payment for emergency services under Sec.  482.2 of 
this chapter. Moreover, the definition of local hospital would require 
the ASC to consider the most appropriate facility to which the ASC 
would transport its patients in the event of an emergency. If the 
closest hospital could not accommodate the patient population or the 
predominant medical emergencies associated with the types of surgeries 
performed by the ASC, a more distant hospital might also meet the local 
definition. Regardless of any business issues that arise between ASCs 
and their local hospital, the ASC would be required to transfer 
patients to the nearest, most appropriate local hospital, since this 
would affect patient health. Any transfers that do not meet the 
requirements of proposed Sec.  416.41(b)(1) and (2) would be determined 
to be out

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of compliance with Medicare regulations.
    Lastly, we are also proposing the addition of a disaster 
preparedness standard at Sec.  416.41(c). In response to the problems 
affecting health care facilities across much of the Gulf Coast region 
in September 2005 as a result of Hurricane Katrina, we are proposing 
this requirement to ensure the health and safety of patients and staff 
members alike. The ASC's governing Body, as part of the ASC leadership 
component, would be responsible for maintaining a written disaster 
preparedness plan that would provide for the emergency care of patients 
in the event of fire, natural disaster, functional failure of 
equipment, or other unexpected events or circumstances that threaten 
the health and/or safety of its patients and staff members. We 
recommend ASCs coordinate the plan with their State and local agencies, 
as appropriate. In an effort to achieve successful outcomes in a real-
life disaster emergency, we are proposing at Sec.  416.41(c)(3), that 
ASCs conduct annual drills for effectiveness. The ASC would then also 
be required to complete a written evaluation of every disaster drill 
and immediately implement any corrections to the plan.
2. Condition for Coverage--Quality Assessment and Performance 
Improvement (Sec.  416.43)
    The existing ``Evaluation of quality'' requirement found at Sec.  
416.43, relies on a problem-oriented, reactive approach and primarily 
focuses on ASC self-assessment and evaluation of the procedures already 
performed and appropriateness of care issues. However, during the last 
decade, the health care industry has moved beyond the problem-oriented 
approach of monitoring quality assurance to an approach that addresses 
quality improvement prospectively through focused projects designed to 
reduce errors and address omissions of care before patients are 
adversely affected. We have already introduced the QAPI philosophy to 
the hospital, hospice and end stage renal disease facility programs 
either through a final regulation or a proposed rule. To raise the 
performance expectations for ASCs seeking entrance into the Medicare 
program, as well as the expectations of those ASCs already 
participating in Medicare, we are proposing that each ASC also develop, 
implement, and maintain an effective QAPI program. Our aim is to 
support the development of patient-centered, outcome-oriented efforts 
that focus on patient health and safety. An ASC QAPI program would be 
designed to stimulate the ASC to constantly monitor and improve its own 
performance, and to be responsive to the needs, desires, and 
satisfaction levels of the patients it serves. With an effective QAPI 
program in place, the ASC would be better able to identify and 
reinforce the activities it is doing well, identify activities that are 
leading to poor patient outcomes, and take actions to improve 
performance. The ASC would be expected to take whatever actions are 
necessary to implement improvements in its performance as identified 
through its QAPI program. We are also proposing to change the CfC title 
from ``Evaluation of quality'' to ``Quality assessment and performance 
improvement.''
    In proposed Sec.  416.43(a), Program scope, we are proposing that 
the ASC's QAPI program must include, but not be limited to, an ongoing 
program that demonstrates measurable improvement in patient health 
outcomes, and improves patient safety by using quality indicators or 
performance measures associated with improved health outcomes and with 
the identification of medical errors. Although ASCs may certainly 
develop their own QAPI program, we encourage them to be open to 
considering QAPI programs in use by other health care entities since 
QAPI programs in general contain the same basic elements.
    Monitoring care in an ASC can be challenging since the typical 
patient may be seen for only one visit. Therefore, it is critically 
important that an ASC's QAPI program identify high-risk areas and areas 
of problematic care and conduct follow-up analysis in a timely manner 
to identify specific areas in need of improvement. The ASC would be 
expected to measure, analyze and track quality indicators, including 
adverse patient events, infection control and other aspects of 
performance that include processes of care and services furnished in 
the ASC. Once a problem is identified, we would expect the ASC to 
establish and implement a plan to correct all deficiencies. We would 
expect the ASC to track its improvement and compliance over time to 
determine, in part, if its corrective actions were effective. Because 
staff members are in a unique position to provide the ASC with 
structured feedback on its performance and suggestions on how 
performance can be improved, we would expect the ASC to utilize staff 
in conducting its QAPI program. An ASC that decided to utilize an 
outside resource to conduct its QAPI program would still need to have 
its staff involved in the process.
    In proposed Sec.  416.43(b), Program data, we would require the ASC 
to utilize quality indicator data to monitor the effectiveness and 
safety of services, and identify opportunities for improving the ASC's 
services. Where an ASC professional organization has made QAPI-related 
programs available to ASCs, we believe an ASC should consider exploring 
the feasibility of using such applicable programs to meet its needs. We 
would encourage ASCs to use a wide variety of information and data, in 
addition to their own findings, to guide improvement efforts. This 
information could include material available from national accrediting 
and other ASC organizations such as the AAAASF, the AAAHC, The Joint 
Commission, and the AOA. Many organizations offer a variety of quality 
improvement-related services such as benchmarking, quality indicators 
and quality assurance instructions. For example, the AAAHC offers 
information on the AAAHC Institute for Quality Improvement at its Web 
site, https://www.aaahc.org. Information made available by these 
organizations and others could provide an opportunity for an ASC to 
learn about and be more involved in clinical quality performance 
measurement.
    We are not proposing that an ASC utilize specific quality 
indicators or collect specific data. An ASC could utilize existing 
resources or incorporate information from an existing QAPI program 
developed by other organizations, to potentially elicit a greater 
degree of insight into how to improve the quality of its services and 
patient satisfaction rather than developing a totally new program. An 
ASC would be free to develop programs that meet its individual needs 
and, in some cases, might benefit from an internally developed process. 
Regardless of what type of quality improvement program is chosen, we 
would require that the governing body approve the program. Since ASCs 
are currently required to ``conduct an ongoing, comprehensive self-
assessment of the quality of care provided * * *'' under the current 
evaluation of quality measurement requirement at Sec.  416.43, we do 
not believe ASCs will experience a protracted or difficult transition 
period.
    At proposed Sec.  416.43(c)(1), Program activities, we propose to 
require that the ASC set priorities for its performance improvement 
activities that: (1) Focus on high risk, high volume and problem-prone 
areas; (2) consider the incidence, prevalence and severity of 
identified problems; and (3) give priority to improvement activities 
that affect health outcomes, patient safety and quality of care. We 
expect an ASC would take immediate action to resolve any

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identified problems that directly or potentially threaten the care and 
safety of patients. For example, patients with minimal support at home, 
surgery on patients with concurrent health issues, and those whose 
diagnosis and care may be unique to the ASC, could be the subject of 
more intense QAPI activity. Prioritizing areas of improvement would be 
essential for the ASC to gain a strategic view of its operating 
environment and to ensure a consistent quality of care provided over 
time.
    At Sec.  416.43(c)(2), we are proposing that the ASC track adverse 
patient events, examine their causes, implement improvements aimed at 
preventing a reoccurrence of the adverse events and ensure that those 
improvements are sustained over time. We have not proposed specific 
methods that ASCs would be required to use in implementing these 
actions. ASCs would be free to choose methods that are compatible with 
their operations. ASCs would be expected to view their staff as 
partners in the quality improvement process. As a follow-up requirement 
to tracking adverse patient events, we are proposing at Sec.  
416.43(c)(3) that ASCs would implement preventive strategies throughout 
the facility targeting any adverse patient events and ensuring all 
staff members are familiar with these strategies for improvement.
    At Sec.  416.43(d), Performance improvement projects, we are 
proposing the number and scope of improvement projects conducted 
annually must reflect the scope and complexity of the ASC's services 
and operations. For example, we would expect that where endoscopy 
services constitute the majority of an ASC's services, performance 
projects related to endoscopic procedures, issues, and follow-up care 
would be implemented. The ASC would be expected to fully document the 
projects that are being conducted, and documentation, at the very 
least, would be expected to include the reason(s) for implementing the 
project, and a description of the results of the project. Through 
meaningful data collection and analysis of adverse patient events and 
outcomes, an ASC would be able to determine how best to select projects 
that coincide with its existing nature and operations.
    We are proposing at Sec.  416.43(e), Governing body 
responsibilities, that the ASC's governing body would be responsible 
and accountable for ensuring that:
     The ongoing QAPI program is defined, implemented and 
maintained;
     The program addresses priorities and that all improvements 
are evaluated for effectiveness;
     The QAPI data collection methods, frequency and details 
are appropriate;
     Safety expectations are established; and
     Adequate resources are allocated for implementing the 
facility's QAPI program.
    Any long-term program would require acceptance and direction from 
an organization's leadership in order to be successfully implemented, 
thus the ASC governing body's role would be critical to QAPI success. 
Once an improvement plan is developed and implemented, the ASC must 
track its progress to determine its effectiveness. The ASC governing 
body is responsible for assuring that the plan is carried out and that 
documentation can support the effort. If documentation is not 
available, selected requirements would be marked deficient at the time 
of a State survey. We would expect the governing body to be involved in 
the QAPI process. With an effective QAPI program in place and operating 
properly, the ASC could better identify and reinforce the activities it 
is doing well, identify activities that lead to poor patient outcomes, 
and take actions to improve performance.
3. Condition for Coverage--Laboratory and Radiologic Services (Sec.  
416.49)
    The current CfC Laboratory and radiologic services, located at 
Sec.  416.49, would require laboratory and radiological services to be 
provided by certified facilities, regardless of whether the ASC 
performs the services or if the services are referred out to another 
facility.
    In Sec.  416.49, we would divide the current condition into two 
separate standards: Laboratory and radiologic services; in addition, we 
are proposing the expansion of the radiologic services requirement. The 
laboratory standard requirements would not change.
    The proposed changes to the radiologic services standard would 
parallel the current laboratory standard by including requirements that 
the ASC would be required to meet, if applicable, when providing 
services directly or under arrangement.
    The requirement at Sec.  416.49(b)(1) is part of the current 
laboratory and radiologic services condition and the language would 
remain unchanged. The proposed language at Sec.  416.49(b)(2) would 
require the ASC to meet the requirements of the CfCs for portable x-ray 
suppliers found at Sec.  486.100 through Sec.  486.110 of this chapter 
if it is furnishing these services directly. We have also proposed that 
radiologic services furnished under arrangement would be performed by 
an entity that was certified by Medicare as a supplier of portable x-
ray services by meeting the Medicare CfCs for portable x-ray services. 
This change would better ensure that high quality radiologic services 
are available to ASC patients.
4. Condition for Coverage--Patient Rights (Sec.  416.50)
    This proposed new requirement would require ASCs to notify patients 
of their rights, provide for the exercise of rights, establish the 
right of privacy and safety, and maintain the confidentiality of 
clinical records. Although the number of surgical procedures performed 
in ASCs continues to grow (for example, from 1990 to 2000,\2\ the 
annual volume of procedures performed by ASCs increased from 1.3 to 4.3 
million), the current ASC regulation does not address patient rights.
---------------------------------------------------------------------------

    \2\ Department of Health and Human Services Office of Inspector 
General Quality Oversight of Ambulatory Surgical Centers, The Role 
of Certification and Accreditation, Supplemental Report 1, February 
2002, OEI-01-00-00451.
---------------------------------------------------------------------------

    In February 2002, the HHS Office of the Inspector General (OIG) 
issued a report, ``Quality Oversight of Ambulatory Surgical Centers; A 
System in Neglect'' [Janet Rehnquist, Inspector General, OEI-01-00-
00450] which was based on a 2001 assessment of CMS's quality oversight 
of ASCs. The OIG recommended that CMS include a patient rights 
provision in the CfC for ASCs. The report specified that a ``patients' 
rights CfC'' is necessary to address issues such as how ASCs will 
respect patient dignity and resolve patient grievances. In developing 
the patient rights requirement we examined the current requirements for 
end stage renal disease facilities and hospitals.
    The addition of a patient rights provision would be consistent with 
the philosophy of assuring patient participation in his or her care. A 
similar provision has been included in other recently issued rules (for 
example, Hospital Conditions of Participation: Requirements for 
Approval and Re-Approval of Transplant Centers to Perform Organ 
Transplants (72 FR 15198, March 30, 2007)).
    The proposed standard at Sec.  416.50(a), Notice of rights, would 
require the ASC to provide the patient or representative with verbal 
and written notice of the patient's rights in a language and manner the 
patient understands prior to furnishing care to the patient. The ASC 
would also be responsible for posting written notice of the patient 
rights in a place or places within the ASC where they are likely to be 
noticed by patients

[[Page 50475]]

waiting for treatment. In addition, the notice of patient's rights must 
include the name, address and telephone number for a representative in 
the State agency to whom patients can report complaints about ASCs, and 
the CMS Web site for the Medicare Beneficiary Ombudsman (https://
www.cms.hhs.gov/center/ombudsman.asp.). (Section 923 of the Medicare 
Prescription Drug, Improvement and Modernization Act of 2003 (Pub. L. 
108-173) (MMA), mandated the creation of the Medicare Beneficiary 
Ombudsman at section 1808(c) of the Act, to ensure that Medicare 
beneficiaries receive the information and help they need to understand 
their Medicare options and to apply their rights and protections. A 
Medicare Beneficiary Ombudsman Open Door Forum (ODF) has been 
established to provide an opportunity for beneficiaries, their 
caregivers and advocates to publicly interact with the Medicare 
Beneficiary Ombudsman to discuss issues and concerns regarding ways to 
improve the systems and processes within the Medicare program.
    The ASC would also be responsible for meaningfully disclosing, if 
applicable, physician financial interests or ownership in the ASC 
facility in accordance with 42 CFR part 420 (Program Integrity). The 
ASC must disclose the information in writing and furnish it to the 
patient prior to the first visit.
    The disclosure of financial information should be such that 
patients and their representatives are able to clearly understand if 
the physician(s) who will be performing a procedure has a financial 
relationship with the ASC. It is incumbent on the ASC to be able to 
provide information that is not only technically correct, but which is 
also easily understood by persons not familiar with financial 
statements, legal documents or technical language. The ASC should be 
aware of the age and the cognitive abilities of its patients and 
recognize that older patients may be confused when presented with a 
document that they cannot readily understand at first glance.
    In Sec.  416.50(a)(2), Advance directives, the ASC would also be 
responsible for providing the patient or representative with verbal and 
written information concerning its policies on advance directives, 
including a description of applicable State law and, if requested, 
official State advance directive forms. In addition, the ASC would be 
required to inform the patient or representative of the patient's right 
to make informed decisions regarding their care, and to document in a 
prominent part of the patient's current medical record, whether or not 
the individual has executed an advance directive.
    We believe that ASCs should be given flexibility to meet this 
requirement within the context of their unique patient populations. 
Differences exist among ASCs and, therefore, ASCs should be allowed to 
determine the process they would use to comply with this proposed 
requirement. As a result, we are not establishing specific guidelines 
for implementation. We also believe that the ASC should be aware that 
questions may arise when informing patients of their rights; and 
therefore, they should provide ample time for answering questions.
    If the patient is unable to effectively communicate in English, the 
ASC could have the family members assist in providing an explanation of 
rights. If a family member is not available, an ASC could make 
arrangements to furnish translation services to ensure that patients 
understand their rights. We would expect that advance patient 
scheduling would enable the ASC to secure the translation services that 
might be necessary. If the ASC is not able to furnish translation 
services and believes that neither the patient nor his or her 
representative will understand the explanation of rights, the ASC would 
be required to reschedule the procedure or request assistance from the 
parties in securing translation services. ASCs would have flexibility 
in determining how best to inform patients of their rights. We would 
also require that a written explanation of patient rights would be made 
available to the patient in a language the patient could understand.
    Most Medicare facilities, including hospitals, critical access 
hospitals, skilled nursing facilities, nursing facilities, home health 
agencies, and hospices are required to maintain written policies and 
procedures that meet the requirements for advance directives for all 
adult individuals receiving medical care. In Sec.  489.100, an advance 
directive is defined as a written instruction, such as a living will or 
durable power of attorney for health care, that is recognized under 
State law, whether statutorily or by the courts of the State, and 
relates to the provision of health care when the individual is 
incapacitated.
    The current ASC regulation does not contain an advance directive 
provision. This is because Medicare suppliers of services, of which an 
ASC is one type, are not currently required to maintain written 
policies and procedures concerning advance directives. However, because 
ASCs are performing an increasing number of surgical procedures on 
Medicare beneficiaries, many of which are invasive and require general 
anesthesia, we are proposing that advance directives be made available 
in an ASC.
    We are also proposing a requirement entitled ``Submission and 
investigation of grievances'' at Sec.  416.50(a)(3). This requirement 
would respond directly to the OIG report referenced earlier regarding 
management of patient grievances and any alleged violations against 
patients.
    Grievance procedures are already in effect for numerous health care 
providers including ASCs. Similar to other internal procedures (for 
example, admission and discharge procedures, infection control 
procedures and others that are common to health care entities) the 
development and implementation of grievance procedures vary. Therefore, 
we have determined that it would be better to allow ASC to establish 
the specifics of a grievance system that may match its current one or 
needs rather than requiring that every ASC conform to a single 
grievance system.
    We are proposing that the ASC would establish clearly explained 
procedures for documenting the existence, submission, investigation, 
and disposition of grievances presented to the ASC (either written or 
verbal) made by the patient or the patient's representative. ASCs would 
document all alleged violations related to and including, but not 
limited to, mistreatment, neglect, verbal, mental, sexual or physical 
abuse. If other allegations of mistreatment arise, such as theft of 
personal property, the ASC would document this allegation, as well. The 
ASC would immediately report these allegations to a person in authority 
in the ASC, the State, and local bodies having jurisdiction, and the 
State survey agency if warranted, to the extent that such reports are 
consistent with the Health Insurance Portability and Accountability Act 
of 1996 (Pub. L. 104-191) (HIPAA) and privacy provisions.
    We are proposing that the grievance process specify time frames for 
review and response to the grievance. We are also proposing the ASC 
would be required to investigate, document, and respond to all 
grievances made by a patient or the patient's representative regarding 
treatment or care that is (or fails to be) furnished.
    We are proposing that certain information be captured when 
documenting and responding to grievances. Proposed documentation should 
include such information as how the grievance was addressed, the steps 
taken during the investigation; written

[[Page 50476]]

notice to the patient or representative of the ASC's decision 
(containing the name of an ASC contact person); the results of the 
grievance process; and the date the grievance process was completed 
consistent with HIPAA and privacy requirements. ASCs could use 
different approaches to effectively meet this CfC. We would set forth 
the general elements that should be common to grievance processes 
across all ASCs, but we are not explicitly delineating strategies and 
policies that ASCs are required to use to comply with the requirement. 
Also, we would leave the degree of documentation to the discretion of 
the ASC.
    The OIG Report specifies the growing need for a grievance process 
which would ensure that ASCs provide quality care. It also specifies 
that the process should provide Medicare consumers with a forum to have 
their grievances about ASCs documented and investigated by State 
agencies and accreditors. The process should also identify poor or even 
dangerous ASCs for intervention and follow-up. Consistent with the 
recommendations in the OIG's report, we are proposing a new standard, 
``Exercise of rights and respect for property and person,'' at Sec.  
416.50(b) which would specify that every patient would have the right 
to: (1) Exercise his or her rights without being subjected to 
discrimination or reprisal; (2) voice grievances regarding treatment or 
care that is (or fails to be) furnished; and (3) be fully informed 
about a treatment or procedure and the expected outcome before it is 
performed.
    In addition, if the patient is determined to be incompetent under 
State law by a court of proper jurisdiction, the person appointed under 
State law could act on the patient's behalf. If a State court has not 
adjudged the patient incompetent, any legal representative designated 
by the patient in accordance with State law could exercise the 
patient's rights on his or her behalf to the extent allowed by State 
law. The ASC would retain flexibility in developing the policies that 
would support these rights. Although, we are not proposing a specific 
method stating how the ASC would implement Sec.  416.50(b), we expect 
that an ASC would educate its staff on the importance of patients' full 
exercise of their rights and record and maintain complete and full 
documentation with respect to allegations concerning violation of these 
rights.
    We would propose at Sec.  416.50(c), Privacy and safety, that 
patients have the right to personal privacy and safety, to receive care 
in a safe setting, and to be free from all forms of abuse or 
harassment. For example, ASCs would be required to provide a private 
space in which patients could disrobe and wait until the surgical 
procedure begins because we believe it is inappropriate for patients to 
be required to sit in a public waiting area while in a hospital gown 
with other fully clothed or similarly gowned patients or be in a common 
patient area without the benefit of partitions. This right would also 
allow patients, for example, to identify and report dangerous or unsafe 
conditions, harassment or abusive behaviors within the ASC that the 
patient believes could negatively impact the services received at the 
ASC. We believe this requirement would act as an additional safeguard 
to patient health and safety.
    The proposed ``Confidentiality of clinical records standard'' at 
Sec.  416.50(d) is designed to safeguard patients against unauthorized 
use of their clinical record. We would assure that the patient's right 
to confidentiality consistent with HIPAA standards and that access to 
or release of patient information and clinical records is permitted 
only with written consent of the patient or representative or as 
authorized by law. We are proposing to add this requirement because 
patients have the right to communicate with health care providers in 
confidence and to have the confidentiality of their health care 
information protected. In addition, all ASCs would be required to 
comply with the HIPAA health information privacy rule at 45 CFR parts 
160 and 164.
5. Condition for Coverage--Infection Control (Sec.  416.51)
    There is currently a requirement for Infection control. The current 
requirements on infection control are incorporated within the Physical 
environment standard of the Environment Condition for coverage (Sec.  
416.44). Current requirements include the establishment of a program 
for identifying and preventing infections, maintaining a sanitary 
environment, and reporting the results to appropriate authorities.
    We propose to establish a separate condition for infection control 
since control of infection is critically important to overall patient 
and staff health and safety.
    We believe that surgery in an ASC must not entail a greater risk of 
infection to the patient than surgery in an inpatient setting. Medicare 
approved surgical procedures are performed in a variety of settings and 
we believe that an effective infection control program should be 
present in all ASCs. One primary cause of infections is poor surgical 
technique and follow-up care. The Centers for Disease Control and 
Prevention (CDC) 1999 Guideline for Prevention of Surgical Site 
Infection [Infection Control and Hospital Epidemiology, Vol. 20 No. 4], 
also states that serious surgical infections can be explained by the 
emergence of antimicrobial-resistant pathogens and the increased 
numbers of surgical patients who are elderly. Furthermore, the CDC also 
reports that two million people are affected by infections that 
annually occur in hospitals and not including those healthcare 
associated infections that occur in long-term care facilities, 
ambulatory-care facilities and outpatient settings (CDC. Public health 
focus: surveillance, prevention and control of nosocomial infections 
(MMWR 1992; 41: 783-7)). A recent report on maximizing hand hygiene 
compliance and improved outcomes published in Infection Control Today 
reported that healthcare associated infections subject patients to 
increased risk of morbidity and mortality, increased durations of care 
and increased healthcare treatment costs (E. Fendler and P. Groziak; 
Maximizing Hand-Hygiene Compliance to Improve Outcomes: A New Tool for 
Infection Control, Infection Control Today, November 2001). Furthermore 
the report by Fendler and Groziak, according to CDC estimates, states 
that implementing effective infection control programs prevents one-
third of these infections.
    The proposed infection control condition would place accountability 
on ASCs to prevent, control, and investigate infections and 
communicable diseases, and take action that result in improvements for 
those problematic areas identified and monitored as part of the 
proposed QAPI program. However, the proposed infection control 
condition allows flexibility for ASCs to determine how to meet these 
objectives. This includes the flexibility to determine how much 
training in infection control is necessary for the ASCs personnel.
    The first standard, sanitary environment, would require the ASC to 
provide a sanitary environment by following acceptable infection 
control standards of practice in the ASC setting to avoid sources and 
transmission of infections and communicable diseases. We have proposed 
to expand the current requirement of maintaining a sanitary environment 
to include the utilization of infection control standards of practice 
as guidelines in the ASC infection control program.

[[Page 50477]]

    The proposed infection control program standard would require the 
ASC to designate a qualified professional, such as a registered nurse, 
as the infection control officer. The infection control program would 
operate under the direction of that designated individual who would be 
accountable for the investigation and resolution of infection and 
communicable disease incidents. In addition, the infection control 
program would be required to follow an organized plan of action to 
identify infection control problems and implement corrective measures 
and preventive mechanisms when necessary. We considered requiring ASCs 
to meet CDC and Occupational Safety and Health Administration (OSHA) 
standards for providing an environment to avoid infections and 
communicable disease. However, such a requirement would raise questions 
as to which CDC or OSHA standards must be met. Moreover, where dual 
sets of professionally recognized standards exist, we would not wish to 
restrict ASC flexibility by mandating compliance with a particular body 
of standards. Therefore, we are not mandating that ASCs follow any 
specific set of infection control guidelines.
    However, we would strongly encourage the ASCs adhere to infection 
control guidelines that are published by the CDC, the Association of 
Practitioners in Infection Control (APIC) and the JCAHO as a reference 
for the utilization of infection control standards of practice.
    As stated in the infection control standard, infection control must 
be an integral part of the QAPI program. In addition, infection control 
would also be targeted as a required area to be monitored in the 
proposed QAPI condition. The designated ASC personnel responsible for 
the infection control program would be required to coordinate with the 
QAPI program to maintain and improve outcomes in ASC infection control.
    We would expect that the ASC will integrate knowledge gained from 
past and current experiences to modify policies, procedures or practice 
that would lead to improvements for those problematic areas identified 
and monitored as part of the QAPI program.
    We also considered including specific requirements concerning 
preoperative hand/forearm antisepsis between surgical patient contacts. 
The CDC reports that failure to perform appropriate hand hygiene is 
considered the leading cause of healthcare associated infections and 
spread of multi-resistant organisms and has been recognized as a 
substantial contributor to outbreaks. (Centers for Disease Control and 
Prevention, Guideline For Hand Hygiene in Health-Care Settings, October 
25, 2002; Vol. 51; No. RR-16). However, we believe the ASC's obligation 
to protect patients and staff from facility acquired infections could 
be assured if an ASC is required to follow current infection control 
standards of practice. ASCs would be held accountable for establishing 
hand hygiene policies. Adequate policy and practice of hand hygiene 
between all patients that addresses antiseptic agents used, scrubbing 
technique, duration of the scrub, condition of the hands, and 
techniques used for drying and gloving would all fall under the 
responsibilities of the ASC to protect its staff and patients from 
infection.
    In addition, we are not proposing to include a prescriptive 
requirement that mandates a specific method of cleaning and 
sterilization of equipment utilized in ASC procedures. We would require 
each ASC to be responsible for creating and implementing its own 
policies and procedures for proper instrument cleaning and maintenance 
of the sterilization equipment to prevent patient exposure to 
infectious organisms by ensuring all equipment is properly cleaned and 
sterilized. If an ASC utilizes equipment that has been improperly 
sterilized, a potential exists to put all of its patients at risk.
    With the increasing popularity of ASCs, adherence to the most basic 
elements of infection control, like simple hand hygiene techniques, are 
of paramount importance.
6. Condition for Coverage--Patient Admission, Assessment and Discharge 
(Sec.  416.52)
    This proposed condition continues to reflect a more patient-
centered approach and underscores our view of essential steps to 
improve quality of care and patient outcomes. The proposed new 
condition would augment the current regulations that require an 
evaluation of the patient for anesthesia risk before surgery and proper 
recovery from anesthesia before discharge.
    As noted by the former CMS Administrator, Dr. Mark McClellan, 
during his testimony before the Senate Finance Committee on May 18, 
2006, ``Medicare payments to ASCs are expected to better reflect the 
resources required to perform specific surgical procedures and to be 
similar to payments under other payment systems. In its 2005 Report to 
Congress, CMS found that many orthopedic surgical specialty hospitals 
were more similar to ASCs than to acute care hospitals.'' To address 
this problem, CMS is developing revisions to the payment rates and also 
the list of procedures eligible for payment. The payment revisions are 
slated to be in effect by January 1, 2008, and it is anticipated there 
will be many more procedures performed in ASCs than in the past. We 
believe that with the expansion of procedures being performed in ASCs, 
there is a need for a requirement that addresses thorough patient 
assessment and recovery issues.
    Older patients generally face greater risks when using anesthetics 
during surgical procedures than do younger patients. The normal aging 
process can extend healing time, increase the recovery time from 
medications, and complications may be more severe (Merck Manual of 
Geriatrics, Section 3, Chapter 27, Anesthesia Considerations). It is 
our intent to ensure that accurate and thorough assessments would be 
conducted to assure appropriate and safe surgery, and that patients 
would be able to tolerate a scheduled surgical procedure.
    We are proposing this new condition as a method to capture specific 
patient care requirements in the pre-admission, pre-surgical, post-
surgical and discharge phases of the ASC surgery process. The core 
objectives of this condition would be to ensure: (1) The patient can 
tolerate a surgical experience; (2) the patient's anesthesia risk and 
recovery are properly evaluated; (3) the patient's post-operative 
recovery is adequately evaluated; (4) the patient receives effective 
discharge planning; and (5) the patient is successfully discharged from 
the ASC.
    Under the first proposed standard, ``Admission and pre-surgical 
assessment'', we would propose that each patient must have a 
comprehensive medical history and physical assessment completed not 
more than 30 days before the date of scheduled surgery by a physician 
(as defined in section 1861(r) of the Act), or other qualified 
practitioner in accordance with State law and ASC policy. We are 
proposing the 30-day time limit to remain consistent with our hospital 
conditions of participation that also requires a medical history and 
physical assessment be completed no more than 30 days before an 
elective procedure or admission. In addition, to ensure the ASC 
healthcare team would have all patient information available if needed, 
the ASC would be required to place the medical history and physical 
assessment in the patient's medical record before the surgical 
procedure is started.
    The information to be included in the assessment would be 
determined by the

[[Page 50478]]

ASC based on accepted standards of practice and the characteristics, 
health risks and needs of the patient. ASCs would continue to have the 
flexibility to define the content and extent of the pre-surgical 
assessment; however, we would propose several items that must be 
included. The pre-surgical assessment entry in the medical record would 
be required to include an updated entry documenting an examination for 
any changes in the patient's condition since the most recently 
documented medical history and physical assessment. In addition, we 
believe that ASCs must provide specific documentation addressing the 
patient's capacity, both physically and mentally, to undergo the 
planned surgery and documentation of any allergies. As stated in the 
current pre-surgical assessment requirement at Sec.  416.42(a), a 
physician is required to examine the patient immediately before surgery 
to evaluate the risk of anesthesia and of the procedure to be 
performed. The proposed additional pre-assessment items are to be 
completed by a physician or other qualified practitioner in accordance 
with State law and in conjunction with the current pre-surgical 
requirements. We believe that this proposed standard would set a clear 
expectation for a direct, effective relationship between the patient 
medical history and assessment and the procedures performed; a 
relationship that is essential for achieving desired healthcare 
outcomes.
    The proposed standard Sec.  416.52(b), ``Post-surgical assessment'' 
would require the ASC to ensure that a thorough assessment of the 
patient's post-surgical condition is completed, documented in the 
medical record and that any post-surgical needs are addressed and 
included in the discharge notes. We propose to retain the current 
standard at Sec.  416.42(a) that requires a physician to evaluate each 
patient for anesthesia recovery before discharge. The post-surgical 
assessment must be performed by a physician or other qualified 
practitioner in accordance with State law. The post-surgical assessment 
would assess all body systems and identify any unforeseen or 
unanticipated post-surgical medical issues. The goal would be to 
decrease the amount of post-surgical complications experienced after 
discharge in the home recovery setting.
    The last proposed standard, Discharge, would require the ASC to 
provide each patient with written discharge instructions and ensure 
that all patients have the best possible transition to home and that 
all post-surgical needs would be met. In addition, we are proposing 
that each patient have a discharge order signed by the physician or the 
qualified practitioner who performed the surgery or procedure unless 
otherwise specified by State law. The discharge order must indicate 
that the patient has been evaluated for proper anesthesia and medical 
recovery. The requirement of a signed discharge order would ensure our 
beneficiaries are stable and safe to be discharged. We believe it is 
imperative, especially in preparation for the upcoming changes to the 
approved procedures in an ASC setting, that a physician or the 
qualified practitioner who performed the surgery or procedure be 
available to provide assistance in the ASC if needed, until all 
patients have been given a signed discharge order by the aforementioned 
practitioner. We believe this would eliminate any confusion with 
respect to the level of care and the ability of the ASC to respond to a 
patient emergency before the patient is discharged. We have not 
included language specifically requiring a physician to be on the 
premises while there are patients in the ASC. However, when the 
di