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[Federal Register Volume 76, Number 205 (Monday, October 24, 2011)]
[Proposed Rules]
[Pages 65891-65908]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27175]

Federal Register / Vol. 76, No. 205 / Monday, October 24, 2011 / 
Proposed Rules

[[Page 65891]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 482 and 485

[CMS-3244-P]
RIN 0938-AQ89

Medicare and Medicaid Programs; Reform of Hospital and Critical 
Access Hospital Conditions of Participation

AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of 
Health and Human Services.

ACTION: Proposed rule.

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SUMMARY: This proposed rule would revise the requirements that 
hospitals and critical access hospitals (CAHs) must meet to participate 
in the Medicare and Medicaid programs. These proposed changes are an 
integral part of our efforts to reduce procedural burdens on providers. 
This proposed rule reflects the Centers for Medicare and Medicaid 
Services' (CMS') commitment to the general principles of the 
President's Executive Order 13563, released January 18, 2011, entitled 
``Improving Regulation and Regulatory Review.''

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on December 23, 
2011.

ADDRESSES: In commenting, please refer to file code CMS-3244-P. Because 
of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways (please choose only one 
of the ways listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY:
    Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, Attention: CMS-3244-P, P.O. Box 8010, Baltimore, MD 
21244-8010. 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 to 
the following address ONLY:
    Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, Attention: CMS-3244-P, Mail Stop C4-26-05, 7500 
Security Boulevard, Baltimore, MD 21244-1850.
    4. By hand or courier. Alternatively, you may deliver (by hand or 
courier) your written comments ONLY to the following addresses prior to 
the close of the comment period:
    a. For delivery in Washington, DC--Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, Room 445-G, Hubert 
H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 
20201.
    (Because access to the interior of the Hubert H. Humphrey 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.)
    b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    If you intend to deliver your comments to the Baltimore address, 
call telephone number (410) 786-9994 in advance to schedule your 
arrival with one of our staff members.
    Comments erroneously mailed to the addresses indicated as 
appropriate for hand or courier delivery may be delayed and received 
after the comment period.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT:

CDR Scott Cooper, USPHS, (410) 786-9465.

Jeannie Miller, (410) 786-3164.

Lisa Parker, (410) 786-4665.

Mary Collins, (410) 786-3189.

Diane Corning, (410) 786-8486.

Sarah Fahrendorf, (410) 786-3112.

SUPPLEMENTARY INFORMATION:
    Submitting Comments: We welcome comments from the public on all 
issues set forth in this proposed rule to assist us in fully 
considering issues and developing policies. You can assist us by 
referencing the file code (CMS-3244-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: http://www.regulations.gov. Follow the search instructions 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.

Acronyms

AHA American Hospital Association
AOA American Osteopathic Association
APRN Advanced Practice Registered Nurse
BBA Balanced Budget Act
CAH Critical Access Hospital
CCN CMS Certification Number
CDC Centers for Disease Control and Prevention
CfC Condition for Coverage
CoP Condition of Participation
CMS Centers for Medicare & Medicaid Services
DNV Det Norske Veritas
EACH Essential Access Community Hospital
H&P History and Physical Examination
HAI Healthcare-Associated Infection
HFAP Healthcare Facilities Accreditation Program
HHS U.S. Department of Health and Human Services
MRHFP Medicare Rural Hospital Flexibility Program
OBRA Omnibus Budget Reconciliation Act
OPO Organ Procurement Organization
PA Physician Assistant
RIA Regulatory Impact Analysis
RFA Regulatory Flexibility Act
RPCH Rural Primary Care Hospital
SBA Small Business Administration
SBREFA Small Business Regulatory Enforcement Fairness Act
UMRA Unfunded Mandates Reform Act

Table of Contents

    This proposed rule is organized as follows:

I. Background
    A. Introduction
    B. Legal Basis and Purpose of Hospital CoPs
    C. Relationship of This Rulemaking to Future Reforms
II. Provisions of the Proposed Regulation
    A. Revisions To Allow Flexibility and Eliminate Burdensome CoPs
    1. Governing Body (Sec.  482.12)
    2. Patient's Rights (Sec.  482.13)
    3. Medical Staff (Sec.  482.22)
    4. Nursing Services (Sec.  482.23)
    5. Medical Record Services (Sec.  482.24)
    6. Infection Control (Sec.  482.42)
    7. Outpatient Services (Sec.  482.54)
    8. Transplant Center Process Requirements--Organ Recovery and 
Receipt (Sec.  482.92)

[[Page 65892]]

    9. Definitions (Sec.  485.602) and Provision of Services (Sec.  
485.635)
    B. Clarifying Changes
    10. Pharmaceutical Services (Sec.  482.25) and Infection Control 
(Sec.  482.42)
    11. Personnel Qualifications (Sec.  485.604)
    12. Surgical Services (Sec.  485.639)
    C. Other Options Considered
III. Collection of Information Requirements
IV. Response to Comments
V. Regulatory Impacts
VI. Regulations Text

I. Background

A. Introduction

    This proposed rule reflects the Centers for Medicare and Medicaid 
Services' (CMS') commitment to the general principles of the 
President's Executive Order 13563, released January 18, 2011, entitled 
``Improving Regulation and Regulatory Review.'' In this proposed rule 
we seek to reduce the regulatory burden placed on hospitals. We have 
identified a number of existing hospital CoPs that we believe could be 
reformed, simplified, or eliminated in order to reduce unnecessary 
burden and costs placed on hospitals and critical access hospitals 
(CAHs) under existing regulations. Earlier this year, the President 
reaffirmed his commitment to Executive Order 12866, which was issued in 
1993 and has long governed the process of regulatory development and 
review. He also issued Executive Order 13563 directing agencies to 
select the least burdensome approaches, to minimize cumulative costs, 
to simplify and harmonize overlapping regulations, and to identify and 
consider flexible approaches that maintain freedom of choice for the 
American public. Executive Order 13563 also requires agencies to engage 
in a process of reviewing existing regulations to see if those rules 
make sense and continue to be justified. The reforms contemplated in 
this proposed rule are intended to meet the letter and spirit of the 
requirement in the President's Executive Order 13563, issued January 
18, 2011, entitled ``Improving Regulation and Regulatory Review,'' for 
reviewing existing regulations to see if those rules make sense and 
continue to be justified. They also meet the objectives of section 610 
of the Regulatory Flexibility Act (RFA), which also requires agencies 
to review the impact of existing rules on small businesses or other 
small entities for possible reforms to reduce burden and costs.
    Under this initiative, we are conducting a retrospective review of 
the CoPs that we apply to hospitals, in order to remove or revise 
obsolete, unnecessary, or burdensome provisions. Most of the existing 
hospital requirements have developed over decades, reflecting new 
statutory requirements, changes in technology or medical practice, and 
the evolution of the health delivery system. The goal of this 
retrospective review is to reduce system costs by removing obsolete or 
burdensome requirements.

B. Legal Basis and Purpose of Hospital CoPs

    Sections 1861(e)(1) through (8) of the Social Security Act (the 
Act) provide that a hospital participating in the Medicare program must 
meet certain specified requirements. Section 1861(e)(9) of the Act 
specifies that a hospital also must meet such other requirements as the 
Secretary finds necessary in the interest of the health and safety of 
individuals furnished services in the institution. Under this 
authority, the Secretary has established regulatory requirements that a 
hospital must meet to participate in Medicare at 42 CFR part 482, CoPs 
for Hospitals. Section 1905(a) of the Act provides that Medicaid 
payments from States may be applied to hospital services. Under 
regulations at 42 CFR 440.10(a)(3)(iii) and 42 CFR 440.20(a)(3)(ii), 
hospitals are required to meet the Medicare CoPs in order to 
participate in Medicaid.
    On May 26, 1993, CMS published a final rule in the Federal Register 
entitled ``Medicare Program; Essential Access Community Hospitals 
(EACHs) and Rural Primary Care Hospitals (RPCHs)'' (58 FR 30630) that 
implemented sections 6003(g) and 6116 of the Omnibus Budget 
Reconciliation Act (OBRA) of 1989 and section 4008(d) of OBRA 1990. 
That rule established requirements for the EACH and RPCH providers that 
participated in the seven-state demonstration program that was designed 
to improve access to hospital and other health services for rural 
residents.
    Sections 1820 and 1861(mm) of the Act, as amended by section 4201 
of the Balanced Budget Act (BBA) of 1997, replaced the EACH/RPCH 
program with the Medicare Rural Hospital Flexibility Program (MRHFP), 
under which a qualifying facility can be designated as a CAH. CAHs 
participating in the MRHFP must meet the conditions for designation 
specified in the statute and, under section 1820(c)(2)(B)(i)(I) of the 
Act, must meet the CoPs located at 42 CFR part 485, subpart F. Among 
such requirements, a CAH must be located in a rural area (or an area 
treated as rural) and must be located more than a 35-mile (or in the 
case of mountainous terrain or in areas with only secondary roads 
available, more than a 15-mile drive) from a hospital or another CAH 
unless otherwise designated as a necessary provider prior to January 1, 
2006.
    The CoPs are organized according to the types of services a 
hospital may offer, and include specific, process oriented requirements 
for each hospital service or department. The purposes of these 
conditions are to protect patient health and safety and to ensure that 
quality care is furnished to all patients in Medicare-participating 
hospitals. In accordance with Section 1864 of the Act, State surveyors 
assess hospital compliance with the conditions as part of the process 
of determining whether a hospital qualifies for a provider agreement 
under Medicare. However, under section 1865 of the Act, hospitals can 
elect to be reviewed instead by private accreditation organizations 
approved by CMS as having standards and survey procedures that are at 
least equivalent to those used by CMS and State surveyors. CMS-approved 
hospital accreditation programs include those of The Joint Commission 
(TJC), the American Osteopathic Association/Healthcare Facilities 
Accreditation Program (AOA/HFAP), and Det Norske Veritas Healthcare 
(DNV) (See 42 CFR part 488, Survey and Certification Procedures.).

C. Relationship of This Rulemaking to Future Reforms

    The reforms we propose in this rule are intended to reduce the cost 
and burden of existing CoPs. They are based in large part on ideas that 
have been provided to us by hospitals and organizations representing 
hospitals, by health care professionals, and by other stakeholders, as 
well as through recent research and our own evaluation of current 
practices. We are committed to working with, and welcome suggestions 
for future rulemaking from, affected parties to identify other reforms 
to the CoPs that would reduce unnecessary burden on hospitals, while 
allowing hospitals maximum flexibility in meeting the Federal 
requirements necessary to fulfill our quality of care responsibilities.

II. Provisions of the Proposed Regulations

    In accordance with the President's Executive Order 13563, we are 
reviewing regulations in an effort to reduce burden, maximize patient 
safety, and reflect current industry standards. We have identified 
several priority areas in the CoPs for both hospitals (42 CFR part 482) 
and CAHs (42 CFR part 485) to update and revise. Our identification and 
prioritization of these areas was a result of outreach to hospital

[[Page 65893]]

stakeholders, such as the American Hospital Association (AHA) and TJC; 
and internal discussions among various components at CMS. We believe 
that these proposed revisions may eliminate or significantly reduce 
those instances where the CoPs are duplicative, unnecessary, and/or 
burdensome.

A. Revisions To Allow Flexibility and Eliminate Burdensome CoPs

1. Governing Body (Sec.  482.12)
    We propose to revise the ``Governing body'' requirements as 
follows: The Governing body CoP (Sec.  482.12) states that the hospital 
must have an effective governing body that is legally responsible for 
the conduct of the hospital as an institution. We have interpreted the 
governing body CoP as requiring that each hospital facility have a 
separate governing body (http://www.cms.gov/manuals/downloads/som107ap_a_hospitals.pdf).
    Based on our experience with hospitals and the input provided by 
stakeholders through anecdotal evidence, we believe that hospitals in a 
multi-hospital system (defined here as those having more than one CMS 
Certification Number (CCN)) can be effectively governed by a single 
governing body. Thus, we propose to revise and clarify the governing 
body requirement to reflect current hospital organizational structure 
whereby multi-hospital systems have integrated their governing body 
functions to oversee care in a more efficient and effective manner. 
Specifically, we propose to revise Sec.  482.12 to state that ``There 
must be an effective governing body that is legally responsible for the 
conduct of the hospital.''
    We would retain the current provision that requires the persons 
legally responsible for the conduct of the hospital to carry out the 
functions specified in Part 482 of our regulations that pertain to the 
governing body if the hospital does not have an organized governing 
body.
2. Patient's Rights (Sec.  482.13)
    On December 8, 2006, we published a final rule in the Federal 
Register entitled ``Medicare and Medicaid Programs; Hospital Conditions 
of Participation: Patients' Rights'' (71 FR 71378). In that final rule 
we revised the hospital standards for the use of restraint and 
seclusion, and set forth new standards for staff training and death 
reporting. In particular, section 482.13(g) of the final rule requires 
hospitals to report no later than the close of business on the next 
business day following knowledge of the patient's death: (1) Each death 
that occurs while the patient is in restraint or seclusion; (2) each 
death that occurs within 24 hours after the patient has been removed 
from restraint or seclusion; and (3) each death known to the hospital 
that occurs within one week after restraint or seclusion where it is 
reasonable to assume that the restraint or seclusion contributed 
directly or indirectly to the patient's death.
    Included under these broad reporting requirements are those deaths 
in which no seclusion is used, and the only restraints used are soft, 
two-point wrist restraints. The patients typically needing soft two-
point wrist restraints are individuals in critical care settings, such 
as intensive care units, where such restraints are medically necessary. 
For example, soft two-point wrist restraints can be used to prevent 
patients from removing medically necessary devices and equipment such 
as central lines, endotracheal tubes, and nasogastric tubes. CMS is not 
aware of any research--or even any anecdotal information--suggesting a 
cause-and-effect relationship between the use of soft, two-point wrist 
restraints and patient deaths.
    CMS is therefore proposing to modify the reporting requirements for 
hospitals when the circumstances of a patient's death involve only the 
use of soft two-point wrist restraints and no use of seclusion. At 
Sec.  482.13(g)(4) we propose that hospitals would be required to 
notify CMS of the deaths described at Sec.  482.13(g)(2) (soft two-
point wrist restraints and no use of seclusion) within seven days after 
the date of death through a log or other system. We propose that the 
record would include, at a minimum, the patient's name, date of birth, 
date of death, attending physician, primary diagnosis(es), and medical 
record number. We propose that hospitals make the log or other system 
accessible to CMS upon request at all times. We are unable to eliminate 
the reporting requirement for these deaths due to statutory provisions 
in the Children's Health Act that require such deaths to be reported.
    For deaths involving all other types of restraints and all forms of 
seclusion, we would retain the current, more extensive reporting 
requirements, including notice to CMS by telephone, no later than the 
close of business on the next business day following knowledge of the 
patient's death.
    We are proposing to introduce a measure of flexibility to these 
requirements and redesignate them at Sec.  482.13(g)(1), by providing 
additional reporting options, as determined by CMS, which would include 
the use of facsimile, as well as an option for electronic reporting. In 
the event that electronic reporting technology develops more rapidly 
than the requirements for this section, we have proposed the term 
``electronically'' rather than ``email'' to build in a small measure of 
flexibility.
3. Medical Staff (Sec.  482.22)
    The CMS condition of participation on ``Medical Staff,'' at Sec.  
482.22, concerns the organization and accountability of the hospital 
medical staff. CMS first adopted the term ``medical staff'' in 1986 
when it began using the term at Sec.  482.22 in place of 
``physicians,'' to allow hospitals maximum flexibility in the granting 
of privileges and the organization of their professional staff (51 FR 
22010). These changes were introduced to reflect the trend of extending 
patient care responsibilities to practitioners other than doctors of 
medicine or osteopathy. CMS has more recently modernized its approach 
to medical staff requirements with respect to telemedicine services 
through the rule ``Medicare and Medicaid Programs: Changes Affecting 
Hospital and Critical Access Hospital Conditions of Participation: 
Telemedicine Credentialing and Privileging,'' that became effective 
July 5, 2011 (76 FR 25563).
    CMS is now proposing to further modernize hospitals' medical 
staffing policies. We believe these changes would provide hospitals the 
clarity and flexibility they need under federal law to maximize their 
staffing opportunities for all practitioners, and particularly for non-
physician practitioners, under their individual States' laws.
    First, we propose to redesignate Sec.  482.22(a)(2) to Sec.  
482.22(a)(5) and revise it by adding language to clarify that a 
hospital may grant privileges to both physicians and non-physicians to 
practice within their State scope of practice, regardless of whether 
they are also appointed to the hospital's medical staff. That is, 
technical membership in a hospital's medical staff would not be a 
prerequisite for a hospital's governing body to grant practice 
privileges to practitioners.
    Hospitals wishing to bring on additional practitioners without also 
making them members of the medical staff would follow the same 
requirements specified in current regulation. That is, the medical 
staff would examine the credentials of each candidate and make 
recommendations to the governing body. Medical staff conducting the 
evaluations would operate under their own hospitals'

[[Page 65894]]

policies and procedures. Moreover, the medical staff would continue to 
be limited by State law, and thus would not be permitted to grant a 
practitioner candidate any privileges beyond those allowed in the State 
where the hospital is located, where he or she would ultimately 
practice.
    We believe this proposed language would provide hospitals with the 
clarity they need to explore new and expanded approaches to care 
giving. Hospitals would be able to increase the number of practitioners 
who could perform various functions and duties, up to the regulatory 
boundaries allowed under their State licensing and scope of practice 
laws.
    These proposed revisions are in response to requests received from 
stakeholders prior to the beginning of this rulemaking process. Many of 
these stakeholders expressed the opinion that some CMS requirements, 
particularly those related to medical staff, may stand in direct 
conflict with functions permitted under State practice acts and laws. 
In such cases, our requirements would be unnecessarily restricting the 
scope of practice of certain categories of non-physician practitioners 
(for example, Advanced Practice Registered Nurses (APRNs), Physician 
Assistants (PAs), Physical Therapists (PTs), Speech-language 
Pathologists (SLPs), and Doctors of Pharmacy (PharmDs)). Thus, 
stakeholders maintain, current regulatory impediments may be unduly 
limiting access to care and/or delaying treatment for patients and 
causing undue burden to practitioners (for example, the need to seek 
out physicians to co-sign orders). Our proposed changes would remove 
these barriers and allow hospitals to move forward in new ways to 
improve patient care, subject to State law.
    The second area we propose to address relates to the general 
management and oversight of practitioners. Prior to the beginning of 
this rulemaking process, we received questions from some hospitals 
about the appropriate credentialing and privileging process for APRNs. 
We believe the changes we are proposing at Sec.  482.22(a)(5) would 
address them. For example, some hospitals have questioned whether APRNs 
should be managed by the human resources department, as most registered 
nurses are, or by the medical staff, as most PAs are. We believe that, 
to the extent allowed under their States' law, most hospitals already 
manage and oversee the services of APRNs through their medical staffs. 
In fact, technically, our current regulations already allow hospitals 
to appoint non-physician practitioners as members of their medical 
staffs, if the State law in which their hospital operates permits it. 
However, the numerous questions we have received in this area indicate 
that our current regulation is unclear. Therefore, we are proposing 
language to revise the section by clarifying that being a member of a 
hospital's medical staff is not a prerequisite to being granted 
privileges in the hospital, regardless of whether a practitioner is a 
physician or a non-physician.
    One of our chief concerns, in the context of proposing this change, 
is to ensure that all practitioners working at a hospital would 
continue to follow the rules set forth for ``Medical Staff'' at Sec.  
482.22. Thus, we are proposing language within this provision that 
would require those physicians and non-physicians, who have been 
granted practice privileges within their scope of practice but without 
appointment to the medical staff, to be subject to the requirements 
contained within this section. That is, they would be subject to the 
same hospital requirements, medical staff bylaws, and medical staff 
oversight as outlined under this CoP and to which appointed medical 
staff members are also subject. Alternatively, a hospital could 
establish categories within its medical staff to create distinctions 
between practitioners who have full membership and a new category for 
those who could be classified as having an ``associate,'' ``special,'' 
or ``limited'' membership. Such a structure is neither required nor 
suggested; we are providing it here as an example of one possible way 
for a hospital to align all of its practitioners under the ``Medical 
Staff'' rules.
    We believe these proposed changes would complement and build upon 
present state and federal reform initiatives, including those set forth 
in the Affordable Care Act (ACA), to address the healthcare workforce 
shortages. We especially believe these proposed changes would support 
efforts to provide better health care in medically underserved 
communities. These changes would provide more flexibility to small 
hospitals and to critical access hospitals (CAHs) in rural areas and 
regions with a limited supply of primary care and specialized 
providers. They would also provide needed flexibility to hospitals 
located in impoverished urban centers. These changes would also provide 
States with additional regulatory flexibility to support their efforts 
to address the shortage of primary care providers.
    The third area in which we are proposing changes concerns the more 
direct responsibilities for the organization and accountability of the 
medical staff. These requirements are set forth at Sec.  482.22(b)(3). 
Presently, the hospital may assign these management tasks to either an 
individual doctor of medicine or osteopathy or, when permitted by State 
law of the State in which the hospital is located, a doctor of dental 
surgery or dental medicine. CMS proposes to expand the list to include 
doctors of podiatric medicine (DPMs). We believe this change would 
permit a podiatric physician to serve as the president, or its 
equivalent, of a hospital's medical staff in a significant number of 
states. CMS is aware that in such states, the laws underscore the 
widely held conclusion that the education, training, and experience of 
podiatric physicians are similar to that of their allopathic and 
osteopathic colleagues with respect to serving in such a hospital 
leadership position. With this proposed change, CMS wishes to ensure 
its hospital leadership requirements are not in conflict with State 
laws that would otherwise allow podiatric physicians to serve in this 
capacity. Moreover, CMS recognizes that the act of being selected as 
the president of the medical staff reflects the high level of 
confidence in which a candidate is held by his or her peers.
4. Nursing Services (Sec.  482.23)
    We propose to revise the hospital nursing service requirements at 
Sec.  482.23 (b)(4), ``Nursing services,'' which currently requires a 
hospital to ensure that the nursing staff develop, and keep current, a 
nursing care plan for each patient. We propose that for those hospitals 
that use an interdisciplinary plan of care in providing patient care, 
the care plan for nursing services be developed and kept current as 
part of the hospital's overall interdisciplinary care plan.
    An interdisciplinary care plan optimizes the involvement of the 
various healthcare disciplines (such as nursing, respiratory care, 
occupational therapy, and pharmacy) to identify and document patient 
treatment goals and objectives, interventions, and progress in meeting 
those goals and objectives. We propose to revise our requirements to be 
less burdensome and more in line with current practice by proposing 
that, for those hospitals that use an interdisciplinary care plan, the 
nursing services care plan could be integrated into the overall 
hospital interdisciplinary care plan. This would decrease the burden of 
the nursing staff having to develop two care plans, one to fulfill the 
nursing services requirement and the other to fulfill the particular 
hospital's requirement for an

[[Page 65895]]

interdisciplinary care plan, and would improve the quality of patient 
care by the effective and timely communication of information 
pertaining to the nursing care of the patient.
    We propose to revise the current Nursing services CoP at Sec.  
482.23(c) by adding new provisions that would allow for drugs and 
biologicals to be prepared and administered on the orders of 
practitioners other than those specified under Sec.  482.12(c). We are 
also proposing a further revision to Sec.  482.23(c) that would add a 
new provision allowing orders for drugs and biologicals to be 
documented and signed by practitioners other than those specified under 
Sec.  482.12(c). We would allow for these two revisions only if such 
practitioners are acting in accordance with State law, including scope 
of practice laws, and only if the hospital has granted them privileges 
to do so.
    These proposed revisions are in response to requests that CMS 
received from stakeholders prior to our beginning the rulemaking 
process. Many of these stakeholders expressed the opinion that some of 
the CMS requirements impede the scope of practice of certain categories 
of practitioners (for example, APRNs, PAs, and Doctors of Pharmacy 
(PharmDs)). They maintain that such regulatory impediments may limit 
access to care or delay treatment for patients; may cause undue burden 
to practitioners (for example, the need to seek out physicians to co-
sign orders); and may stand in direct conflict with functions allowed 
under State practice laws.
    In proposing these changes, we are aware that some States may not 
allow specific practitioners to exercise such privileges. We are also 
aware that some States may limit the categories of practitioners from 
which a registered nurse (as part of his or her scope of practice) may 
receive and carry out orders. However, we believe that these proposed 
revisions would not only allow hospitals to more fully use these 
practitioners in the care of patients, but that changes to what we view 
as unnecessary regulatory prohibitions would serve to greatly reduce 
the regulatory burden for hospitals and allow for more efficient care 
practices.
    Within this section of the Nursing services CoP, we are also 
proposing changes that would allow hospitals to use standing orders. At 
Sec.  482.23(c)(1)(ii), we propose to allow for the preparation and 
administration of drugs and biologicals on the orders contained within 
pre-printed and electronic standing orders, order sets, and protocols 
for patient orders, but only if such orders meet the requirements of 
Sec.  482.24(c)(3), as discussed below.
    Much of the evidence on the effectiveness of hospital standing 
orders is in the context of their use by Rapid Response Teams (RRTs) 
and then only when applied in a very limited and focused manner. A 
search of the medical literature revealed that there may be additional 
areas where standing orders have some efficacy in the hospital setting. 
(http://www.innovations.ahrq.gov/content.aspx?id=1750; http://www.cdc.gov/mmwr/PDF/rr/rr5416.pdf).
    These areas include:
     Emergency department (ED) admission/triage in particular 
for certain conditions such as acute asthma, acute myocardial 
infarction, and stroke (we would expect that standing orders would be 
authenticated by an ED physician or nonphysician practitioner when 
subsequent orders during the ED visit are authenticated for the 
patient);
     Improving immunization rates (beyond those for influenza 
and pneumococcal as currently allowed under the CoPs); and
     Postoperative recovery areas.
    Although the current hospital CoPs already allow for nurse-
initiated influenza and pneumococcal vaccinations (under medical staff-
approved hospital policy), an expanded use of standing orders for other 
immunizations, which have clearly established and nationally recognized 
guidelines (for example, CDC guidelines for Hepatitis B vaccination of 
at-risk newborns), may be a mechanism, under the CoPs, for improved 
patient care.
    We propose to eliminate the requirement, currently at Sec.  
482.23(c)(3), that non-physicians must have special training in 
administering blood transfusions and intravenous medications. We 
believe that this training is standard practice, and thus does not need 
to be prescribed in these regulations.
    At Sec.  482.23(c)(4) we propose that those who administer blood 
transfusions and intravenous medications do so in accordance with State 
law and approved medical staff policies and procedures. We propose to 
retain Sec.  482.23(c)(4) and redesignate it at Sec.  482.23(c)(5), 
without any content change.
    We also propose additional revisions at proposed Sec.  482.23(c)(6) 
that would allow hospitals the flexibility to develop and implement 
policies and procedures for a patient and his or her caregivers/support 
persons to administer specific medications (non-controlled drugs and 
biologicals).This proposal would be consistent with the current 
practice of giving patients access at the bedside to urgently needed 
medications, such as nitroglycerine tablets and inhalers, and selected 
non-prescription medications, such as lotions and rewetting eye drops. 
These proposed changes would apply to the self-administration of both 
hospital-issued medications and the patient's own medications brought 
into the hospital.
    Hospitals that choose to develop and implement a program that 
allows for patients and caregivers/support persons to administer 
certain medications would be expected to address the program in their 
hospital policies and procedures. We would expect a collaborative 
effort by the hospital's medical staff, nursing department, and 
pharmacy department to develop these policies and procedures. A 
hospital would need to: assure that a practitioner had issued an order, 
consistent with hospital policy, permitting self-administration of 
medications; assess patient and caregiver/support person capacity to 
self-administer specific medications; provide patient and caregiver/
support person instruction regarding the safe and accurate 
administration of the specified drugs and biologicals (for specific 
hospital-issued medications and, if determined to be needed, for a 
patient's own medications brought in from home); ensure the security of 
medications for each patient; identify a patient's own medications and 
visually evaluate those medications for integrity; and document the 
administration of each medication in the patient's medical record.
    We believe that this provision, allowing for patient self-
administration of medication, particularly those medications brought in 
from the patient's home, may provide hospitals with a means to make 
care more patient-centered and adaptable to patient and caregiver/
support person needs.
Medical Record Services (Sec.  482.24)
    On November 27, 2006, CMS published a final rule that made 
revisions to specific provisions of the hospital CoPs at 42 CFR part 
482 (71 FR 68694). The current requirements, as finalized at Sec.  
482.24(c)(1)(i) in the 2006 rule, specify that all orders, including 
verbal orders, must be dated, timed, and authenticated promptly by the 
ordering practitioner. Also included in the rule was an exception to 
this requirement at Sec.  482.24(c)(1)(ii), which allows, for the 5 
year period following January 26, 2007, all orders, including verbal 
orders, to be dated, timed, and authenticated by the ordering 
practitioner or another practitioner who is responsible for the care of 
the patient as specified under

[[Page 65896]]

Sec.  482.12(c) and who is authorized to write orders by hospital 
policy in accordance with State law. When the rule was published in 
late 2006, the 5-year sunset provision was included with the thought 
that such an exception would not be needed five years hence since 
various technologies (for example, computerized physician order entry 
and authentication from a distance through a telecommunication medium) 
would have evolved and proliferated to the extent where in-person 
authentication by a practitioner would no longer be common or 
necessary. Though technologies have certainly advanced in the five 
years since publication of the rule, there is still not universal 
application and use of these advancements in hospitals or among 
practitioners.
    Additionally, Sec.  482.24(c)(1)(iii) establishes that all verbal 
orders must be authenticated based upon Federal and State law; in the 
absence of a State law designating a specific timeframe for the 
authentication of verbal orders, this provision then specifies that all 
verbal orders must be authenticated within 48 hours. Many stakeholders 
in the hospital community, including The Joint Commission and the 
American Hospital Association, have pointed out to us that this 
requirement is not only a particularly burdensome one for hospitals, 
but also one that does not have any appreciable benefit for patients 
with regard to safe care. We are proposing to consolidate three 
existing provisions into one new provision at Sec.  482.24(c)(2). 
Specifically, we would remove existing paragraphs (c)(1)(i) through 
(c)(1)(iii) and add a new Sec.  482.24(c)(2). Existing paragraph (c)(2) 
would be redesignated as (c)(3). This new provision would retain the 
requirement that all orders, including verbal orders, must be dated, 
timed, and authenticated promptly by the ordering practitioner, but 
would add the exception currently contained at Sec.  482.24(c)(1)(ii) 
by allowing for authentication by either the ordering practitioner or 
``another practitioner who is responsible for the care of the patient 
as specified under Sec.  482.12(c) and authorized to write orders by 
hospital policy in accordance with State law.'' In this way we would 
remove the sunset provision and the 48-hour timeframe requirement for 
authentication of orders and instead defer to hospital policy and State 
law for establishment of any timeframe. If there was no State law 
establishing such a timeframe, then a hospital would be allowed to 
establish their own timeframe for authentication of orders, including 
verbal orders.
    Due to the risk of error involved in the use of verbal orders, we 
encourage hospitals to keep the use of such orders to a minimum and to 
establish policies that discourage their use. When verbal orders must 
be used, hospitals should have their own policies in place (e.g., 
``read-back and verify'' requirements) to ensure accuracy in the 
transcribing of orders, particularly those involving medication 
dosages.
    As discussed above in the Nursing services CoP section, we are 
proposing changes to that CoP as well as to the Medical records 
services CoP that would allow hospitals to use standing orders as long 
as certain provisions were met. In this rule, we propose new provisions 
to Sec.  482.24(c)(3) that would allow a hospital to use pre-printed 
and electronic standing orders, order sets, and protocols for patient 
orders only if the hospital: (1) Establishes that such orders and 
protocols have been reviewed and approved by the medical staff in 
consultation with the hospital's nursing and pharmacy leadership; (2) 
demonstrates that such orders and protocols are consistent with 
nationally recognized and evidence-based guidelines; (3) ensures that 
the periodic and regular review of such orders and protocols is 
conducted by the medical staff, in consultation with the hospital's 
nursing and pharmacy leadership, to determine the continuing usefulness 
and safety of the orders and protocols; and (4) ensures that such 
orders and protocols are dated, timed, and authenticated promptly in 
the patient's medical record by the ordering practitioner or another 
practitioner responsible for the care of the patient as specified under 
Sec.  482.12(c) and authorized to write orders by hospital policy in 
accordance with State law.
    For additional guidance on the use of standing orders, stakeholders 
should review the CMS memorandum (CMS S&C-09-10) issued on October 24, 
2008 (http://www.cms.gov/SurveyCertificationGenInfo/downloads/SCLetter09-10.pdf), where we pointed out our strong support of the use 
of evidence-based protocols, developed by the medical staff and based 
on recognized standards of practice, that advance the quality of care 
provided to patients. CMS, through the CoPs, requires hospitals and 
practitioners to take a thoughtful and responsible approach when using 
pre-printed and electronic standing orders, order sets, and protocols, 
particularly those orders that may be initiated as part of an emergency 
response or as part of an evidence-based treatment regimen where it is 
not practicable for a nurse to obtain the order and authentication from 
the physician or practitioner prior to the provision of care. In all 
cases protocols and standing orders must be medically necessary for the 
patients to whom they are applied, and the treating physician must be 
able to modify, cancel, void or decline to authenticate orders that 
were not medically necessary in a particular situation. Under no 
circumstances should a hospital use standing orders in a manner that 
requires any staff not authorized to write patient orders to make 
clinical decisions outside of their scope of practice in order to 
initiate such orders. Hospital policies and procedures that discuss the 
use of standing orders should address well-defined clinical scenarios 
as a standard of practice for the use of such orders. We would expect 
the policies and procedures to also address the process by which a 
standing order is developed; approved; monitored; initiated by 
authorized staff; and subsequently authenticated by physicians or 
practitioners responsible for the care of the patient. Under the CoPs, 
all orders, whether written or verbal, must be authenticated and 
documented in the patient's medical record by a practitioner 
responsible for the care of the patient.
    We would also expect to see specific criteria for a nurse or other 
authorized personnel to initiate the execution of a particular standing 
order clearly identified in the protocol for the order, for example, 
the specific clinical situations, patient conditions, or diagnoses by 
which initiation of the order would be justified. Policies and 
procedures should also address the instructions that the medical, 
nursing, and other applicable professional staff receive on the 
conditions and criteria for using standing orders as well as any 
individual staff responsibilities associated with the initiation and 
execution of standing orders. An order that has been initiated for a 
specific patient must be added to the patient's medical record at the 
time of initiation, or as soon as possible thereafter. Likewise, 
standing order policies and procedures must specify the process whereby 
the physician or other practitioner responsible for the care of the 
patient acknowledges and authenticates the initiation of all standing 
orders after the fact, with the exception of influenza and pneumococcal 
polysaccharide vaccines, which do not require such authentication in 
accordance with Sec.  482.23(c)(2).

[[Page 65897]]

    The policies and procedures must also establish a process for 
monitoring and evaluating the use of standing orders, including proper 
adherence to the order's protocol. There must also be a process for the 
identification and timely completion of any requisite updates, 
corrections, modifications, or revisions to pre-printed and electronic 
standing orders, order sets, and protocols.
    We believe that these proposed changes would do much to advance the 
practice of evidence-based medicine and would ensure more consistent 
care for all patients.
6. Infection Control (Sec.  482.42)
    CMS introduced Infection Control as a CoP in 1986 amidst growing 
recognition that infections and communicable diseases were potentially 
exposing hospital patients to significant pain and risk, and driving up 
direct hospital charges (51 FR 22010, 22027). The regulation increased 
hospital accountability and sought to identify, prevent, control, 
investigate, and report infections and communicable diseases of 
patients and hospital personnel. The regulation also established a 
requirement for hospitals to keep a log to identify problems and for 
improvement to be made when problems were identified.
    Since this requirement was published, advances in infection control 
surveillance systems have made the need for a separate infection log 
obsolete. We have also received complaints from stakeholders that the 
log requirement is too prescriptive and burdensome. We therefore 
propose to eliminate the current requirement at Sec.  482.42(a)(2), 
proposing instead to allow hospitals flexibility in their approach to 
the tracking and surveillance of infections. The modern surveillance 
systems already in use include infection detection, data collection and 
analysis, monitoring, and evaluation of preventive interventions. These 
activities are already required at Sec.  482.42(a)(1), which we propose 
to retain under Sec.  482.42(a). Specifically, the infection control 
officer or officers are required to develop a system for identifying, 
reporting, investigating, and controlling infections and communicable 
diseases of patients and personnel. The requirements at Sec.  
482.42(a), together with modern surveillance practices, have made the 
requirement for a separate infection control log unnecessarily 
redundant and burdensome.
7. Outpatient Services (Sec.  482.54)
    Under the CoPs, the provision of outpatient services is an optional 
hospital service. However, if a hospital provides outpatient services, 
the services must meet the needs of patients according to acceptable 
standards of practice as required at Sec.  482.54. The current 
provision at Sec.  482.54(b)(1) also requires the hospital to assign an 
individual to be responsible for outpatient services.
    We are aware that increasingly more hospital services are offered 
as outpatient services today than when this particular CoP was first 
developed. As hospitals have expanded the outpatient services offered 
to patients, many hospitals have determined that it is in the best 
interests of patient safety and management practices to appoint more 
than one individual to oversee the various services offered and also to 
fully integrate their outpatient services with inpatient services. 
Additionally, these hospitals have realized that as they have expanded 
the variety of outpatient services offered, a single outpatient 
services leader may not possess the training and expertise to oversee 
the myriad services that the hospital is capable of providing in the 
outpatient setting. For example, a hospital that offers pediatric, 
gynecological, and orthopedic outpatient services may find it 
advantageous and more efficient to have each of these outpatient 
departments managed by a professional with a background and expertise 
in the relevant specialty and who is also responsible for these 
hospital departments in the inpatient setting. Rather than have just 
one individual, who may only have qualifications and experience in one 
of these areas, as the person responsible for only the outpatient 
services of all three specialties, hospitals would be able to make more 
efficient use of department directors who would oversee both inpatient 
and outpatient services for a particular specialty. In fact, the 
current regulations at Sec.  482.54(a) require outpatient services to 
be, ``integrated with inpatient services.''
    Under the current requirement at Sec.  482.54(b)(1), hospitals that 
are using multiple leaders must hire another director to oversee these 
highly qualified and expert directors who are already exercising 
responsibility for their respective areas, often for both inpatient and 
outpatient services. We have reason to believe, and feedback from 
stakeholders has confirmed that this situation may be causing 
unnecessary staff costs, increased administrative burden, and confused 
chains of command within a hospital regarding its management of patient 
services.
    Therefore, in this proposed rule, we are proposing revisions to 
this CoP that would allow hospitals greater flexibility in determining 
the management structure of outpatient services that would be tailored 
to the scope and complexity of the services offered by an individual 
hospital. We propose to change the existing provision at Sec.  
482.54(b) by revising the provision at Sec.  482.54(b)(1) to allow 
hospitals to assign one or more individuals to be responsible for 
outpatient services. We also propose to revise the current provision at 
Sec.  482.54(b)(2), which currently requires a hospital to have 
appropriate professional and nonprofessional personnel available at 
each location where outpatient services are offered, by proposing to 
add a measure of flexibility such that hospitals would make their 
personnel decisions based on the scope and complexity of outpatient 
services offered.
8. Transplant Center Process Requirements--Organ Recovery and Receipt 
(Sec.  482.92)
    On March 30, 2007, CMS published a final rule entitled ``Medicare 
Program: Hospital Conditions of Participation: Requirements for 
Approval and Re-Approval of Transplant Centers To Perform Organ 
Transplants'' (72 FR 15198). This final rule set forth hospital CoPs 
for the approval and re-approval of transplant centers at 42 CFR part 
482, subpart E, including Sec.  482.92, the section involving blood 
type and other vital data verification. Likewise, CMS addressed the 
regulatory requirements for organ procurement organizations in the 2006 
final rule entitled ``Medicare and Medicaid Programs; Conditions for 
Coverage for Organ Procurement Organizations (OPOs),'' which published 
in the May 31, 2006 Federal Register (71 FR 30982). This rule set forth 
the Conditions for Coverage (CfCs) for OPOs, and it, too, included 
requirements for blood type verification. The transplant center and OPO 
rules were designed to work in tandem to achieve CMS' goals of safe, 
effective, and efficient care for all patients. However, since the time 
of publication, CMS has become aware of the potential for duplicative, 
overlapping efforts related to blood type verification. This proposed 
rule would address this unnecessary duplication by removing certain 
blood type verification requirements for transplant centers set forth 
at Sec.  482.92(a).

[[Page 65898]]

    As further described below, the requirements set forth in the 
transplant center rule at Sec.  482.92(a) and in the OPO rule at Sec.  
486.344(d)(2)(ii) and Sec.  486.344(e) are redundant and burdensome for 
providers as presently structured. Each blood type and other data 
verification requires documentation which must be physically signed and 
retained. For cases where the recovery is conducted by a surgeon on 
call for the OPO recovering for his/her own program, both the OPO and 
transplant center rules apply. As a practical matter, this has meant 
one set of paperwork for each entity, and, in some cases, a third set 
of paperwork maintained with the surgeon's records. The transplant 
hospital must maintain a copy of its signed verification and make it 
available for the onsite surveyors of its organ transplant program. 
OPOs maintain blood matching documentation for their onsite surveyors 
as well. In practice, for such cases, this means organ recovery teams 
must produce and protect two sets of paperwork alongside the recovered 
organs.
    In addition, because the ultimate recipient is not always known at 
the time of organ recovery, as there may be several potential matches 
pending the final receipt of lab work confirming the compatibility of 
various blood antigens, the management of paperwork verifying the blood 
types for each intended organ recipient becomes even more burdensome.
    In order to reduce the amount of verification paperwork, CMS 
proposes to amend the existing regulations governing transplant centers 
by removing the provision at Sec.  482.92(a) which requires the 
transplant team to verify blood type before organ recovery. We would 
redesignate current paragraph (b) and (c) as (a) and (b), respectively.
    CMS is proposing this change in an effort to reduce administrative 
burden for transplant centers and the surgeons recovering for these 
centers. We believe this change will also remove any legal ambiguities 
which may arise on behalf of ``on-call'' organ recovery surgeons and 
team members who fall under both the rules of the OPOs they are 
removing the organs for and the rules of the transplant hospitals where 
they are privileged. The change also would produce cost savings because 
the ``extra'' verifications will no longer be conducted.
    Because the blood type verification is conducted at numerous points 
in time and by multiple physicians and clinicians, CMS does not expect 
that this proposed change would impact transplant recipients in an 
adverse manner. In fact, we believe the changes are wholly in keeping 
with our overarching aims to (1) ensure timely care for patients who 
are waiting for organs for transplantation; and (2) establish 
sufficient quality and procedural standards to ensure that transplants 
are performed in a safe and efficient manner. CMS believes the overall 
impact of this change would be to free up time and resources for 
transplant recovery teams and centers. This change is thus expected to 
benefit all parties involved in the practice of organ transplantation.
Definitions (Sec.  485.602) and Provision of Services (Sec.  485.635)
    The current CoP at Sec.  485.602 and Sec.  485.635(b) require CAHs 
to furnish certain types of services directly rather than through 
contracts or under arrangements. Specifically, the CoP at Sec.  
485.635(b) requires CAH staff to provide, as direct services, (1) 
diagnostic and therapeutic services that are commonly furnished in a 
physician's office or at another entry point into the health care 
system; (2) laboratory services; (3) radiology services; and (4) 
emergency procedures.
    In our view, the current regulation does not provide sufficient 
flexibility for the CAH to address efficiencies and alleviate work 
force shortages by affiliating with other providers and entities, as 
well as by utilizing temporary agencies. Healthcare facilities in rural 
settings often face challenges due to limited resources, small size, 
and location with regard to recruiting and retaining appropriately 
qualified health care professionals as employees. Their inability to 
use contracted services in some situations in lieu of hiring employees 
to provide certain services, places an increased burden on CAHs. In 
particular, it may be more efficient for a CAH to contract with a 
provider in the quantity that the CAH requires, to effectively address 
the needs of its patients. Under the current CoP, however, the CAH 
cannot pursue this option for the required services in these specialty 
areas.
    We believe that what is most important in terms of quality and 
safety of care is that these required services are made available by 
the CAH, not that the qualified professionals providing those services 
be employees of the CAH. The proposed revisions to Sec.  485.635(b) 
would eliminate the requirement that CAH staff must provide certain 
services directly and changes the heading of the standard, ``Direct 
services,'' to ``Patient services.'' We also propose to revise the 
language in paragraphs Sec.  485.635(b)(1) through (b)(4), ``that the 
CAH staff furnishes as direct services.'' We believe the proposed 
revisions will provide CAHs with additional flexibility, increase the 
ability of CAHs to provide services that are required to ensure access 
to care, decrease burden on CAHs, and positively impact the costs of 
health care delivery. We also propose to eliminate the definition of 
``Direct Services'' at Sec.  485.602 since it will no longer be 
applicable.
    The governing body, or the person principally responsible for the 
operation of the CAH under Sec.  485.627(b)(2), would continue to be 
responsible for all services furnished by the CAH whether or not they 
are furnished directly, under arrangements, or under agreements. The 
governing body or responsible person must ensure that all furnished 
services enable the CAH to comply with all applicable conditions of 
participation and standards for the contracted services.
    We believe that changing this requirement will alleviate an 
unnecessary burden on CAHs and provide greater access to quality health 
care.

B. Clarifying Changes

10. Pharmaceutical Services (Sec.  482.25) and Infection Control (Sec.  
482.42)
    We propose to make a minor technical change to the requirement at 
Sec.  482.25(b)(6). The current requirement states that drug 
administration errors, adverse drug reactions, and incompatibilities 
must be reported to the hospital's quality assurance program, if 
appropriate. Additionally, we propose to make a minor technical change 
to the requirement at Sec.  482.42(b)(1). The current requirement 
states that the chief executive officer, the medical staff, and the 
director of nursing services must ensure that the hospital-wide quality 
assurance program and training programs address problems identified by 
the infection control officer or officers. Therefore, in both Sec.  
482.25(b)(6) and Sec.  482.42(b)(1) we propose to replace the term 
``quality assurance program'' with the more current term ``quality 
assessment and performance improvement program.'' This change would 
clarify that we expect drug errors, adverse reactions, and 
incompatibilities to be addressed in a hospital's QAPI program, as 
required at Sec.  482.21.
11. Personnel Qualifications (Sec.  485.604)
    Many of the former EACH/RPCH CoPs were adopted for the new CAH 
program (see 62 FR 46008, August 29, 1997), including the definition 
for clinical

[[Page 65899]]

nurse specialist. In this NPRM we are proposing to revise the 
definition of a clinical nurse specialist at Sec.  485.604(a) to 
reflect the definition in the statute at Sec.  1861(aa)(5)(B). 
Specifically, we propose to change the definition at Sec.  485.604(a) 
to state that a clinical nurse specialist is a registered nurse 
licensed to practice nursing in the State in which the clinical nurse 
specialist services are performed, that holds an advanced degree in a 
defined clinical area of nursing from an accredited educational 
institution.
12. Surgical Services (Sec.  485.639)
    The current surgical services CoP was promulgated in 1995 (60 FR 
45814, September, 1, 1995) to ensure adequate health and safety 
protection for patients. However, the provision of surgical services is 
not a required CAH service under the Act at section 1820(c); therefore, 
we are proposing to make changes to this CoP to clarify that it is an 
optional service for CAHs. The proposed technical change to the CoP 
introductory text is as follows:
    ``If a CAH provides surgical services, surgical procedures must be 
performed in a safe manner by qualified practitioners who have been 
granted clinical privileges by the governing body of the CAH or 
responsible individual in accordance with the designation requirements 
under paragraph (a) of this section.''

C. Other Options Considered

    In addition to the proposals discussed above, we considered the 
alternative options, described below, for revising the CoPs.
Medical Staff (Sec.  482.22)
    Similar to the changes proposed in this rule that would allow a 
multi-hospital system the option of having a single governing body 
legally responsible for the conduct of the hospital (Sec.  482.12), we 
considered changes to the Medical staff CoP at Sec.  482.22 that would 
allow a multi-hospital system the option of having a single organized 
medical staff responsible for the quality of medical care provided to 
patients by all of the hospitals in the system. Stakeholders have 
reported that multi-hospital systems have both integrated their 
governing body functions and their medical staff functions to oversee 
patient care in a more efficient manner.
    The current language of Sec.  482.22 states that the hospital 
``must have an organized medical staff that operates under bylaws 
approved by the governing body and is responsible for the quality of 
medical care provided to patients by the hospital.'' We do not believe 
that the current Medical staff CoP language implies that we require a 
single and separate medical staff for each hospital within a multi-
hospital system. Therefore, we have retained the current requirement 
without revision. However, based on the anecdotal evidence and input 
provided by stakeholders on this issue, we request comment on whether 
we need to propose any clarifying language.
    Based on stakeholder feedback, we considered revising the overall 
organizational structure of the CoPs to condense current requirements 
for departmental leadership responsibilities into a single, non-
specific CoP that would allow hospitals to appoint hospital leaders 
based on hospital-established qualifications and needs specific to each 
hospital. However, we believe that the department-specific organization 
of the current CoPs, and the current specialty-department-specific 
leadership requirements, are appropriate, and can be compatible with 
the leadership standards of our stakeholders. We are specifically 
seeking comment on this issue.
Medical Record Services (Sec.  482.24)
    We considered modifying the regulatory requirement at current Sec.  
482.24(c)(2) to clarify the intent of the rule in situations where a 
patient has received a medical history and physical examination (H&P) 
by either a non-hospital practitioner or a practitioner with hospital 
privileges prior to the patient's hospital visit. When an H&P has been 
completed for a patient within the most recent 30-day period prior to 
the patient's admission or registration, the current regulation 
requires a hospital to ensure documentation of, ``[a]n updated 
examination of the patient, including any changes in the patient's 
condition. * * *''
    We believe that some stakeholders may be interpreting our current 
requirements in a way that would require a hospital to conduct a full 
update to an H&P that was conducted within 30 days prior to the 
patient's admission or registration. As put forth in our November 27, 
2006 final rule related to this issue (``Medicare and Medicaid 
Programs; Hospital Conditions of Participation: Requirements for 
History and Physical Examinations; Authentication of Verbal Orders; 
Securing Medications; and Postanesthesia Evaluations,'' 71 FR 68673, 
68675) and as stated in our current Interpretive Guidelines (CMS. 
``State Operations Manual.'' Pub 100-07, Appendix A, http://cms.gov/manuals/Downloads/som107ap_a_hospitals.pdf), a hospital may adopt a 
policy allowing submission of an H&P prior to the patient's hospital 
admission or registration by a practitioner who may not be a member of 
the hospital's medical staff or who does not have admitting privileges 
by that hospital, or by a qualified licensed individual who does not 
practice at that hospital but is acting within his/her scope of 
practice under State law or regulation. When an H&P is completed within 
the 30 days before admission or registration, the hospital must ensure 
that an updated medical record entry documenting an examination for any 
changes in the patient's condition is placed in the patient's medical 
record. This examination must be conducted by a practitioner who is 
credentialed and privileged by the hospital's medical staff to perform 
an H&P.
    The update note to the H&P must document an examination for any 
changes in the patient's condition since the time that the patient's 
H&P was performed that might be significant for the planned course of 
treatment. If, upon examination, the licensed practitioner finds no 
change in the patient's condition since the H&P was completed, he/she 
may indicate in the patient's medical record that the H&P was reviewed, 
the patient was examined, and that ``no change'' has occurred in the 
patient's condition since the H&P was completed. We note that we do not 
specify the extent of the examination that must be conducted; rather, 
we defer to the clinical judgment of hospital staff to determine the 
extent of the necessary H&P update. We believe that our interpretation 
of the H&P update requirement assures that all patients undergoing 
surgery or anesthesia are properly evaluated for all contraindications 
in accordance with the clinical judgment of hospital staff without an 
undue duplication of services and documentation. Therefore, we do not 
believe that the regulation should be amended. We are specifically 
seeking comment on this issue.
Physical Environment (Sec.  482.41)
    Currently, hospitals are required to meet the standards of the 2000 
edition of the Life Safety Code (LSC), which is not the most recent 
edition. Many accrediting bodies, as well as state and local 
jurisdictions, require hospitals to comply with more recent versions, 
such as the 2003, 2006, or 2009 edition of the LSC. Complying with both 
the 2000 edition of the LSC, for Federal purposes, and a more recent 
edition, for accreditation or other purposes, can be challenging for 
hospitals when there are

[[Page 65900]]

inconsistencies between the two versions.
    We expect the 2012 edition of the LSC to be released in Fall 2011. 
Based on the content of the 2012 edition, we will decide whether it or 
another more recent edition, is appropriate for incorporation into the 
regulations for hospitals and other affected providers and suppliers. 
Any regulatory changes would be addressed through separate notice-and-
comment rulemaking. We are specifically seeking comment on this issue.

III. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 60-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. In 
order to fairly evaluate whether an information collection should be 
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act 
of 1995 requires that we solicit comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    We are soliciting public comment on each of these issues for the 
following sections of this document that contain information collection 
requirements (ICRs):
    According to CMS, there are about 4,900 hospitals (not including 
CAHs) that are certified by Medicare and/or Medicaid. We will use those 
figures to determine the burden for this rule. In addition, throughout 
this section, we estimate costs based on average hourly wages for 
different healthcare providers and attorneys. Unless indicated 
otherwise, we obtained these average hourly wages from the United 
States Bureau of Labor Statistics' ``May 2010 National Occupational 
Employment and Wage Estimates United States'' (http://www.bls.gov/oes/current/oes_nat.htm accessed on September 28, 2011). We also added 30 
percent to the indicated average hourly wage to allow for overhead and 
fringe benefits.

A. ICRs Regarding Condition of Participation: Patient's Rights (Sec.  
482.13)

    Proposed Sec.  482.13(g) would remove the current requirement for 
hospitals to notify CMS by telephone no later than the close of 
business the next business day following knowledge of a patient's death 
for patients who die when no seclusion has been used and the only 
restraints used on the patient were soft, non-rigid, cloth-like 
materials, which were applied exclusively to the patient's wrist(s). 
This requirement would include patients who died within 24 hours of 
having been removed from these types of restraints. In those cases, the 
hospital must report to CMS by recording in a log or other system the 
information required at proposed Sec.  482.13(g)(2)(i) and (ii). We are 
proposing this change only for deaths where the patient died while 
either in soft two-point wrist(s) restraints or within 24 hours of 
having been removed from soft two-point wrist(s) restraints provided 
that: (a) There is no reason to believe the death was caused by those 
restraints, (b) that those were the only restraints used, and (c) that 
no seclusion was used.
    We believe that we previously underestimated the burden and costs 
associated with the current reporting requirement. After discussions 
with other CMS staff, we now believe that this reporting would be done 
by a nurse rather than a clerical person and that there are 
substantially more deaths that occurred to patients while they were in 
soft, non-rigid, cloth-like material, which were applied exclusively to 
a patient's wrist(s), or within 24 hours of being removed from this 
type of restraints.
    We will be revising the current burden estimates for OMB control 
number 0938-0328 to reflect the burden estimated to be associated with 
the current regulations and would adjust for any burden reductions 
resulting from this provision once the current proposal is finalized. 
For a more detailed discussion of estimated burden and cost savings, 
please see the Regulatory Impact Analysis section of this rule.

B. ICRs Regarding Condition of Participation: Nursing Services (Sec.  
482.23)

    The current hospital CoPs require that hospitals ensure that the 
nursing staff develops, and keeps current, a nursing care plan for each 
patient (42 CFR 482.23(b)(4)). Proposed 482.23(b)(4) would allow those 
hospitals that have interdisciplinary care plans (ICPs) to have their 
nursing care plans developed and kept current as part of the hospital's 
ICPs. Based on our experience with hospitals, a nurse would develop and 
maintain the nursing care plan for each patient. The nurse would also 
be responsible for identifying the sections of each nursing care plan 
that needed to be integrated into the hospital's ICP and transferring 
that information into the ICP. Thus, allowing hospitals to include the 
nursing care plan in the ICP for each patient would save the nurse the 
time she or he is currently spending identifying and transferring 
information from the separate nursing care plan into the ICP and 
maintaining the separate nursing care plan.
    In the currently approved OMB control number 0938-0328, we 
indicated that the creation and maintenance of a nursing care plan 
constituted a usual and customary business practice and did not assign 
a burden for this requirement in accordance with 5 CFR 1320.3(b)(2). 
Since completing that package, we have reconsidered our estimate of 
that analysis. While we continue to believe that creating and 
maintaining a health care plan for each patient is a usual and 
customary practice for hospitals, we do not believe that is usual and 
customary for hospitals to develop and maintain a separate nursing care 
plan when they also develop and maintain an ICP.
    We will be revising the current burden estimates for OMB control 
number 0938-0328 to reflect the burden estimated to be associated with 
the current regulations and would adjust for any burden reductions 
resulting from this provision once the current proposal is finalized. 
For a more detailed discussion of estimated burden and cost savings, 
please see the Regulatory Impact Analysis section of this rule.

C. ICRs Regarding Condition of Participation: Medical Record Services 
(Sec.  482.24)

    In the currently approved OMB control number 0938-0328, we 
indicated that most of the patient-related activities, such as 
authentication of verbal orders and using standing orders, constituted 
a usual and customary business practice and did not assign a burden for 
this requirement in accordance with 5 CFR 1320.3(b)(2). However, we 
have reconsidered our analysis. We believe that the authentication of 
verbal orders should be governed by state law and not mandated by the 
Federal government. In addition, while writing orders is generally a 
usual and customary business practice in hospitals, hospitals can also 
choose how those orders will be conveyed. We believe that some 
hospitals are not currently using

[[Page 65901]]

standing orders as often as they would choose to due to our CoPs. 
Therefore, by allowing authentication of verbal orders to be governed 
by state law and expanding the use of standing orders, we believe that 
these provisions would result in a burden reduction.
    We will be revising the current burden estimates for OMB control 
number 0938-0328 to reflect the burden estimated to be associated with 
the current regulations and would adjust for any burden reductions 
resulting from this provision once the current proposal is finalized. 
For a more detailed discussion of estimated burden and cost savings, 
please see the Regulatory Impact Analysis section of this rule.

D. ICRs Regarding Condition of Participation: Infection Control (Sec.  
482.42)

    The current hospital CoPs require that ``the infection control 
officer or officers must maintain a log of incidents related to 
infections and communicable disease'' (42 CFR 482.42(a)(2)). We are 
proposing to eliminate this requirement for keeping a dedicated log of 
incidents related to infections and communicable diseases, proposing 
instead to allow hospitals flexibility in their approach to the 
tracking and surveillance of infections.
    In the currently approved OMB control number 0938-0328, we did not 
assign a burden for creating and maintaining this log. However, we have 
reconsidered our analysis. We believe there are many alternatives 
available that present an even greater opportunity to monitor and 
analyze infection control activities than keeping a log as currently 
required by the CoPs. In addition, we believe that the log is a format 
that hospitals are using only because of the CMS requirement and that 
they are producing data in this fashion in addition to the format they 
are using for their own purposes. Thus, while identifying and 
monitoring infections that patient have during hospitalization would be 
usual and customary for hospitals, we believe that requiring hospitals 
to keep a log rather than decide how they could best keep track of this 
information is burdensome for hospitals.
    We will be revising the current burden estimates for OMB control 
number 0938-0328 to reflect the burden estimated to be associated with 
the current regulations and will adjust for any burden reductions 
resulting from this provision once the current proposal is finalized. 
For a more detailed discussion of estimated burden and cost savings, 
please see the Regulatory Impact Analysis section of this rule.

E. ICRs Regarding Condition of Participation: Transplant Center Process 
Requirements--Organ Recovery and Receipt (Sec.  482.92)

    We propose removing 482.92(a) entirely. The elimination of this 
section would remove the burden on the part of transplant centers by 
eliminating a requirement to review and compare blood type and other 
vital data before organ recovery takes place.
    In the currently approved OMB control number 0938-1069, we 
indicated that the verification by the transplant hospital recovery 
physician when the recipient was known constituted a usual and 
customary business practice and did not assign a burden for this 
requirement in accordance with 5 CFR 1320.3(b)(2). However, since that 
PRA package was approved by OMB, several members of the transplant 
community have repeatedly told CMS that this verification was 
unnecessary and burdensome because OPOs already perform this type of 
verification prior to organ recovery in accordance with 
486.344(d)(2)(ii). Therefore, we have reconsidered our estimate of the 
burden for this requirement.
    We will be revising the current burden estimates for OMB control 
number 0938-0328 to reflect the burden estimated to be associated with 
the current regulations and would adjust for any burden reductions 
resulting from this provision once the current proposal is finalized. 
For a more detailed discussion of estimated burden and cost savings, 
please see the Regulatory Impact Analysis section of this rule.

IV. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.

V. Regulatory Impacts

A. Regulatory Impact Analysis

1. Introduction
    We have examined the impacts of this rulemaking as required by 
Executive Orders 12866 (September 1993) and 13563 (January 2011). 
Executive Orders 12866 and 13563 direct agencies to assess all costs 
and benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety 
effects, distributive impacts, and equity). Executive Order 13563 
emphasizes the importance of quantifying both costs and benefits, 
reducing costs, harmonizing rules, and promoting flexibility. A 
Regulatory Impact Analysis (RIA) must be prepared for rules with 
economically significant effects ($100 million or more in any one 
year). This proposed rule is an ``economically'' significant regulatory 
action under section 3(f)(1) of Executive Order 12866. Accordingly, the 
Office of Management and Budget (OMB) has reviewed this proposed rule.
2. Statement of Need
    In Executive Order 13563, the President recognized the importance 
of a streamlined, effective, efficient regulatory framework designed to 
promote economic growth, innovation, job-creation, and competitiveness. 
To achieve a more robust and effective regulatory framework, the 
President has directed each executive agency to establish a plan for 
ongoing retrospective review of existing significant regulations to 
identify those rules that can be eliminated as obsolete, unnecessary, 
burdensome, or counterproductive or that can be modified to be more 
effective, efficient, flexible, and streamlined. Consistent with this 
directive, CMS has conducted a retrospective review of the conditions 
of participation it imposes on hospitals to remove or revise obsolete, 
unnecessary, or burdensome provisions. The goal of the retrospective 
review is to identify opportunities reduce system costs by removing 
obsolete or burdensome requirements while maintaining patient care and 
outcomes.
    CMS had not reviewed the entire set of Conditions of Participation 
for Hospitals in many years. These requirements had grown over time 
and, while often revised, had not been subject to a complete review. 
CMS staff as well as CMS stakeholders, including TJC, the American 
Medical Association, the AHA, and many others, had identified 
problematic requirements over the years. Accordingly, we decided to 
conduct a retrospective review of the conditions of participation 
imposed on hospitals and to remove or revise obsolete, unnecessary, or 
burdensome provisions, and to increase regulatory flexibility while 
identifying and adding opportunities to improve patient care and 
outcomes. We analyzed all potential reforms and revisions of the CoPs 
for both the costs and the benefits that they would bring to hospitals 
and CAHs,

[[Page 65902]]

Based on our analysis, we decided to pursue those regulatory revisions 
that would reflect the substantial advances that have been made in 
healthcare delivery and that would benefit hospitals and CAHs through 
cost savings.
3. Summary of Impacts
    These proposed reductions in process and procedure requirements 
will facilitate redirection of staff resources to higher priorities 
with greater benefit both to patients directly and through the 
increased flexibility that institutions will have to reengineer 
internal processes. We present a summary of these cost reducing changes 
in Table 2.

  Table 1--Section-by-Section Summary of Cost Savings to Hospitals and
                                  CAHs
 [Entries rounded to nearest $100K if under $50M and to nearest $10M if
                                 higher]
------------------------------------------------------------------------
                                                         Annual savings
           Regulatory area                 Section            ($K)
------------------------------------------------------------------------
Patient's Rights--Death Notice Soft             482.13             9,900
 Restraints.........................
Medical Staff.......................            482.22           330,000
Nursing Services--Care Plan.........            482.23           110,000
Medical Record Services--                       482.24            80,000
 Authentication.....................
Medical Record Services--Standing               482.24            90,000
 Orders.............................
Infection Control--Eliminate Log....            482.42             6,600
Outpatient Services.................            482.54           300,000
Transplant Organ recovery...........            482.92               200
CAH Direct Services.................           485.635            15,800
                                     -----------------------------------
    Total...........................  ................           942,500
------------------------------------------------------------------------

    Some of these savings come simply from reductions in process 
requirements and reporting. The changes in the area of Medical staffing 
and several other areas would allow hospitals more flexibility in 
hiring and staffing decisions, including use of part-time and contract 
staff, to provide patient services efficiently and effectively. Total 
national hospital spending is about nine hundred billion dollars a year 
and about half of this is spent on staff compensation (source: AHA 
Hospital Statistics). Thus, the potential magnitude of the efficiencies 
that could be achieved is very large.
    Clearly, the amount of savings actually realized through these 
reforms will depend on the individual decisions of about 6,100 
hospitals (including CAHs), over time. We cannot predict the extent or 
speed of these elective changes. Other factors, such as impending 
physician shortages and the growing use of other practitioners to 
perform many physician functions will play a role as will State 
decisions on laws delineating scope of practice.
    Furthermore, for the requirements that we propose to modify or 
delete, we are not aware of any information suggesting that the change 
we propose would create consequential risks for patients. In other 
words, we do not believe that any requirement we propose to eliminate 
has saved lives in recent decades.
    We welcome comments on ways to better estimate the likely effects 
of these reforms within the broader array of influences on delivery of 
care.
4. Anticipated Impacts
    There are about 4,900 hospitals and 1,200 CAHs that are certified 
by Medicare and/or Medicaid. We use these figures to estimate the 
potential impacts of this proposed rule. According to CMS' Center for 
Medicaid, Children's Health Insurance Program (CHIP), and Survey and 
Certification (CMCS), for fiscal year (FY) 2010, TJC accredited 3,839 
hospitals and 365 CAHs. For TJC-accredited hospitals and CAHs we will 
use the figures of 3,800 and 400, respectively. For non TJC-accredited 
hospitals and CAHs, we will use the figures of 1,100 and 800, 
respectively. In addition, we use the following average hourly wages 
for nurses and physicians respectively: $45 and $124 (BLS Wage Data by 
Area and Occupation, including both hourly wages and fringe benefits, 
at http://www.bls.gov/bls/blswage.htm and http://www.bls.gov/ncs/ect/). 
The analysis below overlaps with the Collection of Information 
Requirements section for many individual items. That section contains 
more technical and legal detail as appropriate under the Paperwork 
Reduction Act, but that is not necessary or appropriate in a Regulatory 
Impact Analysis. Readers may wish to consult both sections on some 
topics.
Death Notices for Soft Restraints (Patient's Rights Sec.  482.13)
    We propose to remove the current requirement for hospitals to 
notify CMS by telephone no later than the close of business the next 
business day following knowledge of a patient's death for patients who 
die when no seclusion has been used and the only restraints used on the 
patient were soft, non-rigid, cloth-like materials, which were applied 
exclusively to the patient's wrists. Reporting would also be removed 
for patients who died within 24 hours of having been removed from these 
types of restraints.
    We estimate that full reporting of all such instances would result 
in 882,000 occurrences. This is much greater than the assumption that 
originally established this reporting requirement in the final rule (71 
FR 71425). However, since the requirements have come into effect, we 
believe our initial estimate was low. Also, the assumption in the 2006 
final rule was that these functions would be carried out by a clerical 
person. Based on our experience with hospitals, this assumption is 
incorrect. A registered nurse would be the more appropriate staff 
member to make the call and to enter the information into a patient's 
medical record. The difference between the average hourly wage for a 
clerical person and a registered nurse ($18.88 per hour versus $45 per 
hour) would account for a significant discrepancy in estimated burden 
between the 2006 final rule and this proposed rule. Similar to the 2006 
rule, we still estimate that it would take about fifteen minutes (or 
.25 hours) to comply with this requirement for each occurrence. The 
estimate of the time is also based on our experiences with hospitals as 
well as feedback from stakeholders that indicates that this estimate is 
reasonable. Therefore, we estimate that this reduction in burden would 
reduce

[[Page 65903]]

a hospital's burden hours by 45 hours each year valued at $45 per hour 
for an annual savings of $2,025. Thus, we estimate that for all 4,900 
hospitals this would result in a savings of about $9,922,500.
Medical Staff (Sec.  482.22)
    Our changes and clarifications regarding medical staff and 
privileging would allow hospitals to substitute and rearrange actual 
delivery of care. In particular, use of Advanced Practice Nurse 
Practitioners (APRNs) and Physician Assistants (PAs) in lieu of higher-
paid physicians could provide immediate savings to hospitals. We have 
no precise basis for calculating potential savings, which in any event 
depend on future staffing and management decisions, but they are very 
substantial. For purposes of this analysis we have reached an estimate 
of $330 million using the following assumptions:
     All hospitals are able, under State scope of practice laws 
(that is, 4,900 hospitals), and one third of these are willing (that 
is, 1,617), to make such medical staff substitutions;
     There are on average 7,000 inpatient hospital stays per 
hospital per year (from AHA Hospital Statistics);
     The average hospital stay is about 5 days (per AHA 
statistics);
     On average, each patient receives approximately 75 minutes 
(1.25 hours) of a physician's time (for example, in-person visits/
assessments, including patient and family education; review of patient 
lab and other diagnostic test results; documentation of orders, 
progress notes, and other entries in the medical record; performance of 
minor procedures; and discussion of the patient's condition with other 
staff) during an average 5-day stay;
     At a minimum, 33 percent of this physician per patient 
time would now be covered by nonphysician practitioners (for example, 
APRNs and PAs); and
     There is an average salary difference of $71 an hour 
between physicians and these practitioners.
    The resulting savings estimate of about $330 million annually 
(1,617 hospitals x 7,000 inpatient hospital stays x 1.25 hours of 
physician/nonphysician practitioner time x $71 per hourly wage 
difference x 33 percent of physician time with patients covered by 
nonphysician practitioners) could obviously be much higher or lower if 
any of the parameters above changed. Additionally, we have restricted 
our estimates to inpatient hospital stays and we did not include a 
discussion of the approximately 620,000,000 annual hospital outpatient 
visits (AHA Hospital Statistics) and the impact that the proposed 
changes could have on staffing costs for hospitals in light of this 
number. Thus, many reasonable variations of our assumptions would lead 
to a similar magnitude of savings. We welcome comments on these 
estimates and on ways to improve them.
Nursing Services Care Plan (Sec.  482.23)
    The current hospital CoPs require that hospitals ensure that the 
nursing staff develops, and keeps current, a nursing care plan for each 
patient. Our proposal would allow those hospitals that have 
interdisciplinary care plans (ICPs) to have their nursing care plans 
developed and kept current as part of the hospital's ICPs.
    Based on our experience with hospitals, a nurse would develop and 
maintain the nursing care plan for each patient. The nurse would also 
be responsible for identifying the sections of each nursing care plan 
that needed to be integrated into the hospital's ICP and transferring 
that information into the ICP. Thus, allowing hospitals to include the 
nursing care plan in the ICP for each patient would save the nurse the 
time he or she is currently spending identifying and transferring 
information from the separate nursing care plan into the ICP and 
maintaining the separate nursing care plan. We believe that many 
hospitals have already developed methods for eliminating this time-
wasting step, particularly those hospitals that have largely 
implemented an electronic health records system. Assuming that about 60 
percent have done so, this reform would only affect roughly 16 million 
patients (40 percent of 40 million admissions).
    We estimate that allowing a hospital to use only the ICP would save 
the nurse an average of nine minutes or 0.15 hours and would affect 
16,000,000 patients. Thus, the proposed provision would result in a 
reduction of 2,400,000 burden hours valued at $45 per hour for a 
savings of $108,000,000.
Medical Record Services--Authentication and Standing Orders (Sec.  
482.24)
    We are proposing to revise the Medical Records CoP to eliminate the 
requirement for authentication of verbal orders within 48 hours if no 
State law specifying a timeframe exists. Since we believe that very few 
States have authentication timeframe requirements, we do not believe 
that the few States that may have such requirements would impact the 
potential savings we are estimating here. We are also proposing to make 
permanent the temporary provision (5-year Sunset provision due to 
expire early 2012) that allows for orders to be authenticated by 
another practitioner who is responsible for the care of the patient and 
who, in accordance with hospital policy State law, is authorized to 
write orders.
    We believe that this provision would result in a burden reduction. 
We would expect a registered nurse or compliance officer to be 
responsible for checking medical records and flagging orders needing 
authentication, particularly those verbal orders nearing the current 
48-hr timeframe. Based on our experience with hospitals and feedback 
from stakeholders on this issue, we believe that hospitals will save 
one hour of a nurse's time every day for 365 burden hours for each 
hospital annually. For all 4,900 hospitals, this would result in a 
reduction of 1,788,500 burden hours, valued at $45 per hour for a 
savings of $80,482,500.
    We are also proposing to add new provisions to allow hospitals to 
use pre-printed and electronic standing orders, order sets, and 
protocols for patient orders if the hospital ensures that these orders: 
have been reviewed and approved by the medical staff and nursing and 
pharmacy leadership; are consistent with nationally recognized 
guidelines; are reviewed periodically and regularly by medical staff 
and nursing and pharmacy leadership; and are dated, timed, and 
authenticated by a practitioner who is responsible for the care of the 
patient and who is authorized to write orders by hospital policy in 
accordance with State law. In addition, we proposed to allow for drugs 
and biologicals to be prepared and administered on the orders of other 
practitioners if they are acting in accordance with State law and scope 
of practice and the hospital has granted them the privileges to do so.
    The use of standing orders, order sets, and protocols reduces a 
hospital's burden in several ways. Initially, it saves the physician or 
other practitioner the time it takes to write out the orders. It also 
saves the physician the time it would take to go back to the chart or 
call a nurse with a verbal order if the physician forgets a particular 
order. The nurses also save time when standing orders are used. The 
orders are more legible so there is less time interpreting and calling 
physicians for verification. Nurses also need to call physicians less 
frequently when there is a change in the patient's condition or they 
feel there needs to be a change in the care the patient is receiving. 
Patients also benefit from standing orders because there would be less 
delay in the delivery of needed care to a patient. Thus, we believe 
that expanding the use of

[[Page 65904]]

standing orders would significantly reduce the hospital's burden.
    Based on our experience with hospitals and on stakeholder feedback 
regarding the issue of standing orders, we estimate that these 
provisions would affect 13 million patients or roughly one-third of 
hospital admissions. We also estimate that using standing orders would 
result in a burden reduction of an average of 4 minutes or 0.07 hours 
for each of these patients. Thus, expanding the use of standing orders 
would result in a reduction of 700,000 burden hours valued at $124 per 
hour for a savings of $86,800,000.
Outpatient Services (Sec.  482.54)
    Our proposed liberalization of outpatient services supervision will 
permit large savings. Under the existing Condition of Participation, 
only one person may direct outpatient services. Similar to our 
estimates for medical staff savings, what savings hospitals may realize 
would depend largely on their future decisions, and cannot be predicted 
with any precision. For purposes of estimation, we have developed an 
estimate that illustrates the potential. Under this estimate, we assume 
that two-thirds of the hours eliminated would represent net savings, 
since existing directors obviously perform significant coordination 
functions that would have to be performed however the work is 
organized. To be more specific, potential savings are based on the 
following:
     Two-thirds of hospitals elected to redirect these overall 
director functions (3,267 hospitals);
     On average, each position represents 2,000 hours per year;
     Only two-thirds of the hours eliminated represented net 
savings; and
     Compensation averages about $70 an hour.
    Based on these assumptions, this reform would produce $305 million 
annually in staff savings (3,267 hospitals x 2,000 hours x \2/3\ x $70 
per hour). A similar result would be obtained if four-fifths of 
hospitals redirected these functions, but the net hours saved were only 
a little more than half of the current hours.
Transplant Organ Recovery (Sec.  482.92)
    We propose removing the current blood typing requirement entirely. 
The elimination of this section would remove transplant center burden 
by eliminating a requirement to review and compare blood type and other 
vital data before organ recovery takes place. The OPOs already perform 
this type of verification prior to organ recovery. In addition, since 
publication of the existing rule, the transplant community has 
repeatedly told CMS that the verification that we propose to delete is 
burdensome and unnecessary.
    Under the current requirements for this situation, the OPO performs 
a verification before organ recovery, the surgeon working for the 
transplant center performs a verification before organ recovery, and 
the transplant center surgeon performs another verification before the 
organ is transplanted. Under the proposed requirement, the OPO performs 
a verification before organ recovery and the transplant center surgeon 
performs a verification before the organ is transplanted. We would 
eliminate the verification that is conducted by the staff working on 
behalf of the transplant center that must occur prior to organ 
recovery. In addition, the responsibility for maintaining these records 
is very unclear, and has caused conflict between surgeons, transplant 
centers, and the hospitals where the organ recoveries are performed. 
Elimination of the extra verification step removes this source of 
conflict and confusion.
    Between July 1, 2009 and June 30, 2010, the United States saw 2,293 
heart and 1,699 lung transplants. During the same time frame, there 
were also 16,679 transplants for kidneys, 6,301 for livers, and 371 for 
pancreases. (Scientific Registry of Transplant Recipients (SRTR) http://srtr.org/csr/current/nats.aspx, date last accessed 6/9/10). Most organ 
recoveries for heart and lung transplants are conducted by surgeons 
working for their own transplant centers. By contrast, in the case of 
kidneys, livers, and pancreases, these organs are typically recovered 
by surgeons who are on-call for an OPO and who are not also working 
for, or privileged at, the same transplant center where the organ is 
delivered. For purposes of this analysis, we assume that 25 percent of 
kidney, liver and pancreas organ recoveries are conducted by surgeons 
who are working for the transplant centers. It is in this small 
percentage of transplant cases, roughly 5,800, together with the total 
number of heart and lung transplants, where the requirement for an 
additional verification has resulted in overlapping and burdensome 
requirements. For the purpose of analysis, we have assumed that 
conducting the verification and filing the corresponding paperwork 
would take 8 minutes and that there are 9,972 transplant cases. We 
therefore conclude that removing the duplicative verification 
requirement will result in an annual savings of 1,305 burden hours 
valued at $124 per hour for a monetary savings of $161,820.
Infection Control Log (Sec.  484.42)
    We are proposing to eliminate a requirement for keeping a dedicated 
log of incidents related to infections and communicable diseases, 
proposing instead to allow hospitals flexibility in their approach to 
the tracking and surveillance of infections. We believe the changes we 
are proposing overall would result in the more efficient use of time.
    We believe that the current log requirement requires roughly 30 
hours annually of a nurse's time per hospital (i.e., an average of 600 
to 900 log entries per year and 2-3 minutes per entry). Thus, for all 
4,900 hospitals this change would result in a savings of 147,000 burden 
hours valued at $45 per hour for a savings of $6,615,000.
CAH Provision of Services (Sec.  485.635)
    Our proposed removal of the ``direct services'' requirement imposed 
on CAHs would eliminate the requirement that certain services be 
provided only by employees and not through contractual arrangements 
with entities such as community physicians, laboratories, or radiology 
services. Opportunities may be limited because CAHS are both small and 
overwhelmingly located in rural areas where there may not be realistic 
alternatives to direct hiring. We estimate that this could produce 
savings of approximately one tenth of one full-time equivalent staff 
person in payroll savings on average, at an average compensation cost 
of $66, for a total of about $16 million saved annually across all 
1,200 CAHs. Savings might be considerably larger, and we welcome 
information and data on this question.
5. Alternatives Considered
    From within the entire body of conditions of participation, the 
most serious candidates for reform were those identified by 
stakeholders, by recent research, or by experts as unusually burdensome 
if not unchanged. This subset of the universe of standards is the focus 
of this proposed rule. We welcome comments on whether we properly 
selected the best candidates for change, and will consider suggestions 
for additional reform candidates from the entire body of conditions of 
participation for hospitals and CAHs.
    A second set of alternatives arises because there are obviously 
various ways to draft each requirement. For each requirement that we 
have proposed for deletion or modification there are a number of 
possible options, including making no change, making the change

[[Page 65905]]

we propose, and in some but not all cases making some in-between 
change. Most standards have an ``either-or'' nature, but we welcome 
comments on possible variations. There is a final set of alternatives 
revolving around entirely different methods of achieving potential 
benefits, such as incentive payments through Medicare or other health 
plans to high-performing institutions, or publishing quality scores to 
make hospital strengths and weaknesses transparent to both the public 
at large and to practitioners. A number of such reforms are underway. 
Likewise, there are alternatives such as technical assistance through 
Quality Improvement Organizations (QIOs) funded by CMS, also underway 
under the latest QIO contracts. We welcome comments on such 
alternatives.
6. Uncertainty
    Our estimates of the effects of this regulation are subject to 
significant uncertainty. While CMS is confident that these reforms 
would provide flexibilities to hospitals that would yield cost savings, 
we are uncertain about the magnitude of these effects. In addition, as 
we previously explained, we do not believe that any requirement we 
propose to eliminate achieved any consequential improvements in patient 
safety. Thus, we are confident that the rule would yield net benefits. 
In this analysis we provided some illustrative estimates to suggest the 
potential savings these reforms could achieve under certain 
assumptions. We welcome comments on ways to better estimate the likely 
effects of these reforms.
7. Accounting Statement
    As required by OMB Circular A-4 (available at http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf), we have prepared an 
accounting statement. As previously explained, achieving the full scope 
of potential savings will depend on future decisions by hospitals, by 
State regulators, and others. Many other factors will influence long-
term results. We believe, however, that likely savings and benefits 
will reach many billions of dollars. Our primary estimate of the net 
savings to hospitals from reductions in regulatory requirements that we 
can quantify at this time, offset by increases in other regulatory 
costs, are approximately $940 million a year. We welcome comments on 
both the overall estimate and its components.

                  Table 2--Accounting Statement: Classification of Estimated Costs and Savings
                                                 [$ in millions]
----------------------------------------------------------------------------------------------------------------
                                                                                           Units
                                                                Primary   --------------------------------------
                          Category                              estimate       Year       Discount      Period
                                                                             dollars        rate       covered
----------------------------------------------------------------------------------------------------------------
Benefits                                                                             None
----------------------------------------------------------------------------------------------------------------
Costs
----------------------------------------------------------------------------------------------------------------
                                                                    -$940         2012           7%      2012-16
                                                             ---------------------------------------------------
Annualized Monetized reductions in Costs                             $940         2012           3%      2012-16
----------------------------------------------------------------------------------------------------------------
Transfers                                                                            None
----------------------------------------------------------------------------------------------------------------

B. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA), as modified by the Small 
Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), requires 
agencies to determine whether proposed or final rules would have a 
``significant economic impact on a substantial number of small 
entities'' and, if so, to prepare a Regulatory Flexibility Analysis and 
to identify in the notice of proposed rulemaking or final rulemaking 
any regulatory options that could mitigate the impact of the proposed 
regulation on small businesses. For purposes of the RFA, small entities 
include businesses that are small as determined by size standards 
issued by the Small Business Administration (SBA), nonprofit 
organizations, and small governmental jurisdictions. Individuals and 
States are not included in the definition of a small entity. The SBA 
size threshold for ``small entity'' hospitals is $34.5 million or less 
in annual revenues. Also, all non-profit hospitals are small entities 
under the RFA. About three-fifths of all hospitals (including CAHs) are 
non-profit and about one-third (many overlapping) have annual revenues 
below the SBA size threshold. Because the great majority qualifies as 
``small entities,'' HHS policy for many years has been to treat all 
hospitals as small entities deserving protection under the RFA. 
Although the overall magnitude of the paperwork, staffing, and related 
cost reductions to hospitals and CAHs proposed under this rule is 
economically significant, these savings are likely to be only about one 
percent of total hospital costs. Total national inpatient hospital 
spending is approximately nine hundred billion dollars a year, or an 
average of about $150 million per hospital, and our primary estimate of 
the net effect of these proposals on reducing hospital costs is only 
about $940 million annually (although potentially far higher). This is 
an average of slightly over $150,000 in savings on average for the 
6,100 hospitals (including CAHs) that are regulated through the 
Conditions of Participation. Under HHS guidelines for Regulatory 
Flexibility Analysis, actions that do not negatively affect costs or 
revenues by about 3 to 5 percent a year are not economically 
significant. We believe that no hospitals of any size will be 
negatively affected. Accordingly, we have determined that this proposed 
rule would not have a significant economic impact on a substantial 
number of small entities, and that an Initial Regulatory Flexibility 
Analysis is not required. Notwithstanding this conclusion, we believe 
that this RIA and the preamble as a whole meet the requirements of the 
RFA for such an analysis.
    In addition, section 1102(b) of the Social Security Act requires us 
to prepare a regulatory impact analysis if a rule may have a 
significant impact on the operations of a substantial number of small 
rural hospitals. This analysis must conform to the provisions of the 
RFA. For purposes of section 1102(b) of the Act, we define a small 
rural hospital as a hospital that is located outside of a Metropolitan 
Statistical Area and has fewer than 100 beds. We do not believe a 
regulatory impact analysis is required here for the same reasons 
previously

[[Page 65906]]

described and because, in addition, our proposals are particularly 
cost-reducing for the smallest hospitals, including especially CAHs 
(which in most cases have no more than 25 beds).

C. Unfunded Mandates Reform Act of 1995

    Section 202 of the Unfunded Mandates Reform Act (UMRA) of 1995 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates on State, local, or Tribal governments 
in the aggregate, or on the private sector, require spending in any one 
year of $100 million in 1995 dollars, updated annually for inflation. 
That threshold level is currently about $136 million. This proposed 
rule would eliminate or reform existing requirements and would allow 
hospitals and CAHs to achieve substantial savings through staffing 
reforms. Accordingly, no analysis under UMRA is required.

D. Federalism

    Executive Order 13132 on Federalism establishes certain 
requirements that an agency must meet when it publishes a proposed rule 
(and subsequent final rule) that imposes substantial direct requirement 
costs on State and local governments, preempts State law, or otherwise 
has Federalism implications. We have determined that this proposed rule 
would not significantly affect the rights, roles, or responsibilities 
of the States. This proposed rule would not impose substantial direct 
requirement costs on State or local governments, preempt State law, or 
otherwise implicate federalism. It does, however, facilitate the 
ability of States to reform their scope of practice laws without 
Federal requirements reducing the effectiveness of such reforms. We 
understand that about half of the States are considering such reforms, 
and we support such efforts.

VI. Regulations Text

List of Subjects

42 CFR Part 482

    Grant programs--Health, Hospitals, Medicaid, Medicare, Reporting 
and recordkeeping requirements.

42 CFR Part 485

    Grant programs--Health, Health facilities, Medicaid, Medicare, 
Reporting and recordkeeping requirements.

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services proposes to amend 42 CFR chapter IV as set forth 
below:

PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS

    1. The authority citation for part 482 continues to read as 
follows:

    Authority: Secs. 1102, 1871 and 1881 of the Social Security Act 
(42 U.S.C. 1302, 1395hh, and 1395rr), unless otherwise noted.

Subpart B--Administration

    2. Section 482.12 is amended by revising the introductory text to 
read as follows:

Sec.  482.12  Condition of participation: Governing body.

    There must be an effective governing body that is legally 
responsible for the conduct of the hospital. If a hospital does not 
have an organized governing body, the persons legally responsible for 
the conduct of the hospital must carry out the functions specified in 
this part that pertain to the governing body.
* * * * *

Sec.  482.13  Condition of participation: Patient's rights.

    3. Section 482.13 is amended by--
    a. Revising paragraphs (g)(1), (g)(2), and (g)(3).
    b. Adding a new paragraph (g)(4).
    The revisions and additions read as follows:

Sec.  482.13  Condition of participation: Patient's rights.

* * * * *
    (g) * * *
    (1) With the exception of deaths described under paragraph (g)(2) 
of this section, the hospital must report the following information to 
CMS by telephone, facsimile, or electronically, as determined by CMS, 
no later than the close of business on the next business day following 
knowledge of the patient's death:
    (i) Each death that occurs while a patient is in restraint or 
seclusion.
    (ii) Each death that occurs within 24 hours after the patient has 
been removed from restraint or seclusion.
    (iii) Each death known to the hospital that occurs within 1 week 
after restraint or seclusion where it is reasonable to assume that use 
of restraint or placement in seclusion contributed directly or 
indirectly to a patient's death, regardless of the type(s) of restraint 
used on the patient during this time. ``Reasonable to assume'' in this 
context includes, but is not limited to, deaths related to restrictions 
of movement for prolonged periods of time, or death related to chest 
compression, restriction of breathing, or asphyxiation.
    (2) When no seclusion has been used and when the only restraints 
used on the patient are those applied exclusively to the patient's 
wrist(s), and which are composed solely of soft, non-rigid, cloth-like 
materials, the hospital staff must report to CMS by recording in a log 
or other system, the following information:
    (i) Any death that occurs while a patient is in such restraints; 
and
    (ii) Any death that occurs within 24 hours after a patient has been 
removed from such restraints.
    (3) For deaths described in paragraphs (g)(1) and (g)(2) of this 
section, staff must document in the patient's medical record the date 
and time the death was reported to CMS.
    (4) For deaths described in paragraph (g)(2) of this section, 
entries into the log or other system must be documented as follows:
    (i) Each entry must be made not later than seven days after the 
date of death of the patient;
    (ii) Each entry must document the patient's name, date of birth, 
date of death, attending physician's name, medical record number, and 
primary diagnosis(es); and
    (iii) The information must be made available in either written or 
electronic form to CMS immediately upon request.

Subpart C--Basic Hospital Functions

    4. Section 482.22 is amended by--
    a. Revising the introductory paragraph.
    b. Revising paragraph (a) introductory text.
    a. Adding a new paragraph (a)(5).
    b. Revising (b)(3).
    The revisions and additions read as follows:

Sec.  482.22  Condition of participation: Medical staff.

    The hospital must have an organized medical staff that operates 
under bylaws approved by the governing body and is responsible for the 
quality of medical care provided to patients by the hospital.
    (a) Standard: Composition of the medical staff. The medical staff 
must be composed of doctors of medicine or osteopathy and, in 
accordance with State law, may also be composed of other practitioners 
appointed by the governing body.
* * * * *
    (5) The medical staff must examine the credentials of candidates 
applying for practice privileges and medical staff membership within 
the hospital, as well as the credentials of practitioners applying only 
for hospital practice privileges, and make recommendations to the 
governing body for the

[[Page 65907]]

appointment of these candidates and the approval of these privileges in 
accordance with State law and hospital policies and procedures. A 
physician or nonphysician practitioner who has been granted practice 
privileges by the governing body for practice activities authorized 
within his or her State scope of practice is subject to all medical 
staff requirements contained in this section.
    (b) * * *
    (3) The responsibility for organization and conduct of the medical 
staff must be assigned only to:
    (i) An individual doctor of medicine or osteopathy,
    (ii) A doctor of dental surgery or dental medicine, when permitted 
by State law of the State in which the hospital is located; or
    (iii) A doctor of podiatric medicine, when permitted by State law 
of the State in which the hospital is located.
* * * * *
    5. Section 482.23 is amended by--
    a. Revising paragraph (b)(4).
    b. Revising paragraph (c).
    The revisions and additions read as follows:

Sec.  482.23  Condition of participation: Nursing services.

* * * * *
    (b) * * *
    (4) The hospital must ensure that the nursing staff develops, and 
keeps current, a nursing care plan for each patient. The nursing care 
plan may be part of an interdisciplinary care plan.
* * * * *
    (c) Standard: Preparation and administration of drugs. (1) Drugs 
and biologicals must be prepared and administered in accordance with 
Federal and State laws, the orders of the practitioner or practitioners 
responsible for the patient's care as specified under Sec.  482.12(c), 
and accepted standards of practice.
    (i) Drugs and biologicals may be prepared and administered on the 
orders of other practitioners not specified under Sec.  482.12(c) only 
if such practitioners are acting in accordance with State law, 
including scope of practice laws, and only if the hospital has granted 
them privileges to do so.
    (ii) Drugs and biologicals may be prepared and administered on the 
orders contained within pre-printed and electronic standing orders, 
order sets, and protocols for patient orders only if such orders meet 
the requirements of Sec.  482.24(c)(3).
    (2) All drugs and biologicals must be administered by, or under 
supervision of, nursing or other personnel in accordance with Federal 
and State laws and regulations, including applicable licensing 
requirements, and in accordance with the approved medical staff 
policies and procedures.
    (3) With the exception of influenza and pneumococcal polysaccharide 
vaccines, which may be administered per physician-approved hospital 
policy after an assessment of contraindications, orders for drugs and 
biologicals must be documented and signed by a practitioner who is 
authorized to write orders in accordance with State law and hospital 
policy, and who is responsible for the care of the patient as specified 
under Sec.  482.12(c).
    (i) If verbal orders are used, they are to be used infrequently.
    (ii) When verbal orders are used, they must only be accepted by 
persons who are authorized to do so by hospital policy and procedures 
consistent with Federal and State law.
    (iii) Orders for drugs and biologicals may be documented and signed 
by other practitioners not specified under Sec.  482.12(c) only if such 
practitioners are acting in accordance with State law and scope of 
practice and only if the hospital has granted them privileges to do so.
    (4) Blood transfusions and intravenous medications must be 
administered in accordance with State law and approved medical staff 
policies and procedures.
    (5) There must be a hospital procedure for reporting transfusion 
reactions, adverse drug reactions, and errors in administration of 
drugs.
    (6) The hospital may allow a patient (or his or her caregiver/
support person where appropriate) to self-administer both hospital-
issued medications and the patient's own medications brought into the 
hospital, as defined and specified in the hospital's policies and 
procedures.
    (i) If the hospital allows a patient to self-administer specific 
hospital-issued medications, then the hospital must have policies and 
procedures in place to:
    (A) Assure that a practitioner responsible for the care of the 
patient has issued an order, consistent with hospital policy, 
permitting self-administration;
    (B) Assess the capacity of the patient (or the patient's caregiver/
support person where appropriate) to self-administer the specified 
medication(s);
    (C) Instruct the patient (or the patient's caregiver/support person 
where appropriate) in the safe and accurate administration of the 
specified medication(s);
    (D) Ensure the security of the medication(s) for each patient; and
    (E) Document the administration of each medication in the patient's 
medical record.
    (ii) If the hospital allows a patient to self-administer his or her 
own specific medications brought into the hospital, then the hospital 
must have policies and procedures in place to:
    (A) Assure that a practitioner responsible for the care of the 
patient has issued an order, consistent with hospital policy, 
permitting self-administration of medications the patient brought into 
the hospital;
    (B) Assess the capacity of the patient (or the patient's caregiver/
support person where appropriate) to self-administer the specified 
medication(s), and also determine if the patient (or the patient's 
caregiver/support person where appropriate) needs instruction in the 
safe and accurate administration of the specified medication(s);
    (C) Identify the specified medication(s) and visually evaluate the 
medication(s)for integrity;
    (D) Ensure the security of the medication(s) for each patient; and
    (E) Document the administration of each medication in the patient's 
medical record.
    6. Section 482.24 is amended by--
    a. Removing paragraphs (c)(1)(i), (c)(1)(ii), and (c)(1)(iii).
    b. Redesignating (c)(2) as (c)(4).
    c. Adding a new paragraph (c)(2).
    d. Adding a new paragraph (c)(3).
    The revisions and additions read as follows:

Sec.  482.24  Condition of participation: Medical record services.

* * * * *
    (c) * * *
    (2) All orders, including verbal orders, must be dated, timed, and 
authenticated promptly by the ordering practitioner or another 
practitioner who is responsible for the care of the patient as 
specified under Sec.  482.12(c) and authorized to write orders by 
hospital policy in accordance with State law.
    (3) Hospitals may use pre-printed and electronic standing orders, 
order sets, and protocols for patient orders only if the hospital:
    (i) Establishes that such orders and protocols have been reviewed 
and approved by the medical staff in consultation with the hospital's 
nursing and pharmacy leadership;
    (ii) Demonstrates that such orders and protocols are consistent 
with nationally recognized and evidence-based guidelines;
    (iii) Ensures that the periodic and regular review of such orders 
and protocols is conducted by the medical staff, in consultation with 
the hospital's

[[Page 65908]]

nursing and pharmacy leadership, to determine the continuing usefulness 
and safety of the orders and protocols; and
    (iv) Ensures that such orders and protocols are dated, timed, and 
authenticated promptly in the patient's medical record by the ordering 
practitioner or another practitioner responsible for the care of the 
patient as specified under Sec.  482.12(c) and authorized to write 
orders by hospital policy in accordance with State law.
* * * * *
    7. In Sec.  482.25 paragraph (b)(6) is revised to read as follows:

Sec.  482.25  Condition of participation: Pharmaceutical services.

* * * * *
    (b) * * *
    (6) Drug administration errors, adverse drug reactions, and 
incompatibilities must be immediately reported to the attending 
physician and, if appropriate, to the hospital's quality assessment and 
performance improvement program.
* * * * *
    8. Section 482.42 is amended by revising paragraph (a) and (b)(1) 
to read as follows:

Sec.  482.42  Condition of participation: Infection control.

* * * * *
    (a) Standard: Organization and policies. A person or persons must 
be designated as infection control officer or officers to develop and 
implement policies governing control of infections and communicable 
diseases. The infection control officer or officers must develop a 
system for identifying, reporting, investigating, and controlling 
infections and communicable diseases of patients and personnel.
* * * * *
    (b) * * *
    (1) Ensure that the hospital-wide quality assessment and 
performance improvement (QAPI) program and training programs address 
problems identified by the infection control officer or officers; and
* * * * *

Subpart D--Optional Hospital Services

    9. Section 482.54 is amended by revising paragraph (b) to read as 
follows:

Sec.  482.54  Condition of participation: Outpatient services.

* * * * *
    (b) Standard: Personnel. The hospital must--
    (1) Assign one or more individuals to be responsible for outpatient 
services.
    (2) Have appropriate professional and nonprofessional personnel 
available at each location where outpatient services are offered, based 
on the scope and complexity of outpatient services.

Subpart E--Requirements for Specialty Hospitals

Sec.  482.92  [Amended]

    10. Section 482.92 is amended by--
    a. Removing paragraph (a).
    b. Redesignating paragraphs (b) and (c) as (a) and (b) 
respectively.

PART 485--CONDITIONS OF PARTICIPATION SPECIALIZED PROVIDERS

    11. The authority citation for part 485 continues to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395(hh)).

Subpart F--Conditions of Participation: Critical Access Hospitals 
(CAHs)

Sec.  485.602  [Removed]

    12. Section 485.602 is removed.
    13. Section 485.604(a) is revised to read as follows:

Sec.  485.604  Personnel qualifications.

* * * * *
    (a) Clinical nurse specialist. A clinical nurse specialist must be 
a person who--
    (1) Is a registered nurse and is licensed to practice nursing in 
the State in which the clinical nurse specialist services are 
performed; and
    (2) Holds an advanced degree in a defined clinical area of nursing 
from an accredited educational institution.
* * * * *
    14. Section 485.635(b) is revised to read as follows:

Sec.  485.635  Condition of participation: Provision of services.

* * * * *
    (b) Standard: Patient services. (1) General: The CAH provides those 
diagnostic and therapeutic services and supplies that are commonly 
furnished in a physician's office or at another entry point into the 
health care delivery system, such as a low intensity hospital 
outpatient department or emergency department. These CAH services 
include medical history, physical examination, specimen collection, 
assessment of health status, and treatment for a variety of medical 
conditions.
    (2) Laboratory services. The CAH provides basic laboratory services 
essential to the immediate diagnosis and treatment of the patient that 
meet the standards imposed under section 353 of the Public Health 
Service Act (42 U.S.C. 236a). (See the laboratory requirements 
specified in part 493 of this chapter.) The services provided include:
    (i) Chemical examination of urine by stick or tablet method or both 
(including urine ketones);
    (ii) Hemoglobin or hematocrit;
    (iii) Blood glucose;
    (iv) Examination of stool specimens for occult blood;
    (v) Pregnancy tests; and
    (vi) Primary culturing for transmittal to a certified laboratory.
    (3) Radiology services. Radiology services furnished by the CAH are 
provided by personnel qualified under State law, and do not expose CAH 
patients or personnel to radiation hazards.
    (4) Emergency procedures. In accordance with requirements of Sec.  
485.618, the CAH provides medical services as a first response to 
common life-threatening injuries and acute illness.
    15. Section 485.639 is amended by revising the introductory text to 
read as follows:

Sec.  485.639  Condition of participation: Surgical services.

    If a CAH provides surgical services, surgical procedures must be 
performed in a safe manner by qualified practitioners who have been 
granted clinical privileges by the governing body, or responsible 
individual, of the CAH in accordance with the designation requirements 
under paragraph (a) of this section.
* * * * *

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program) (Catalog of Federal 
Domestic Assistance Program No. 93.778, Medical Assistance Program)

    Dated: September 30, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
    Approved: October 6, 2011.
Kathleen Sebelius,
Secretary. Department of Health and Human Services.
[FR Doc. 2011-27175 Filed 10-18-11; 11:15 am]
BILLING CODE 4120-01-P
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