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[Federal Register Volume 77, Number 95 (Wednesday, May 16, 2012)]
[Rules and Regulations]
[Pages 29034-29076]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-11548]

[[Page 29033]]

Vol. 77

Wednesday,

No. 95

May 16, 2012

Part IV

Department of Health and Human Services

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Centers for Medicare & Medicaid Services

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42 CFR Parts 482 and 485

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

Federal Register / Vol. 77 , No. 95 / Wednesday, May 16, 2012 / Rules 
and Regulations

[[Page 29034]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 482 and 485

[CMS-3244-F]
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: Final rule.

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SUMMARY: This final rule revises the requirements that hospitals and 
critical access hospitals (CAHs) must meet to participate in the 
Medicare and Medicaid programs. These changes are an integral part of 
our efforts to reduce procedural burdens on providers. This 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: These regulations are effective on July 16, 2012.

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; and Sarah 
Fahrendorf, (410) 786-3112.

SUPPLEMENTARY INFORMATION:

Executive Summary for This Final Rule

A. Purpose

    In Executive Order 13563, ``Improving Regulations and Regulatory 
Review'', the President recognized the importance of a streamlined, 
effective, and 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. This final rule 
responds directly to the President's instructions in Executive Order 
13563 by reducing outmoded or unnecessarily burdensome rules, and 
thereby increasing the ability of hospitals and CAHs to devote 
resources to providing high quality patient care.

B. Summary of the Major Provisions

    Revisions To Allow Flexibility and Eliminate Burdensome Conditions 
of Participation (CoPs): We have reduced burden to providers and 
suppliers by modifying, removing, or streamlining current regulations 
that we have identified as excessively burdensome.
     Single governing body for multiple hospitals: We will 
allow one governing body to oversee multiple hospitals in a multi-
hospital system and have added a requirement for a member, or members, 
of the hospital's medical staff to be included on the governing body as 
a means of ensuring communication and coordination between a single 
governing body and the medical staffs of individual hospitals in the 
system.
     Reporting of Restraint-Related Deaths: We have replaced 
the requirement that hospitals must report deaths that occur while a 
patient is only in soft, 2-point wrist restraints with a requirement 
that hospitals must maintain a log (or other system) of all such 
deaths. This log must be made available to CMS immediately upon 
request. We have indicated that the log is internal to the hospital and 
that the name of the practitioner responsible for the care of the 
patient may be used in the log in lieu of the name of the attending 
physician if the patient was under the care of a non-physician 
practitioner and not a physician.
     Role of other practitioners on the Medical Staff: We have 
broadened the concept of ``medical staff'' and have allowed hospitals 
the flexibility to include other practitioners as eligible candidates 
for the medical staff with hospital privileges to practice in the 
hospital in accordance with State law. All practitioners will function 
under the rules of the medical staff. This change will clearly permit 
hospitals to allow other practitioners (e.g., APRNs, PAs, pharmacists) 
to perform all functions within their scope of practice. We have 
required that the medical staff must examine the credentials of all 
eligible candidates (as defined by the governing body) and then make 
recommendations for privileges and medical staff membership to the 
governing body.
     Medical staff leadership: We have allowed podiatrists to 
be responsible for the organization and conduct of the medical staff. 
This change will allow podiatrists to assume a new leadership role 
within hospitals, if hospitals so choose.
     Nursing care plan: We have allowed hospitals the options 
of having a stand-alone nursing care plan or a single interdisciplinary 
care plan that addresses nursing and other disciplines.
     Administration of medications: We have allowed hospitals 
to have an optional program for patient(s)/support person(s) on self-
administration of appropriate medications. The program must address the 
safe and accurate administration of specified medications; ensure a 
process for medication security; address self-administration training 
and supervision; and document medication self-administration.
     Administration of blood transfusions and intravenous 
medications: We have eliminated the requirement for non-physician 
personnel to have special training in administering blood transfusions 
and intravenous medications and have revised the requirement to clarify 
that those who administer blood transfusions and intravenous 
medications do so in accordance with State law and approved medical 
staff policies and procedures. We believe that this clarification will 
make the requirement consistent with current standards of practice.
     Orders by other practitioners: We have allowed for drugs 
and biologicals to be prepared and administered on the orders of 
practitioners (other than a doctor), in accordance with hospital policy 
and State law, and have also allowed orders for drugs and biologicals 
to be documented and signed by practitioners (other than a doctor), in 
accordance with hospital policy and State law.
     Standing Orders: We have allowed hospitals the flexibility 
to use standing orders and have added a requirement for medical staff, 
nursing, and pharmacy to approve written and electronic standing 
orders, order sets, and protocols. We have required that orders and 
protocols must be based on nationally recognized and evidence-based 
guidelines and recommendations.
     Verbal Orders: We have eliminated the requirement for 
authentication of verbal orders within 48-hours and have deferred to 
applicable State law to establish authentication timeframes.
     Authentication of Orders: We have made permanent the 
previous temporary requirement that all orders, including verbal 
orders, must be dated, timed, and authenticated by either the ordering 
practitioner or another 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.

[[Page 29035]]

     Infection Control Log: We have eliminated the obsolete 
requirement for a hospital to maintain an infection control log. 
Hospitals are already required to monitor infections and do so through 
various surveillance methods including electronic systems.
     Outpatient services director: We have removed the 
burdensome and outdated requirement for a single Director of Outpatient 
Services position that oversees all outpatient departments in a 
hospital. Hospitals already have separate directors for individual 
outpatient departments, so having a single overall Director position is 
duplicative and unnecessary.
     Transplant Center Process Requirements: We have eliminated 
a duplicative requirement for an organ recovery team that is working 
for the transplant center to conduct a ``blood type and other vital 
data verification'' before organ recovery when the recipient is known. 
The verification will continue to be completed at two other times in 
the transplant process.
     CAH Provision of Services: We have eliminated the 
burdensome requirement that CAHs must furnish diagnostic and 
therapeutic services, laboratory services, radiology services, and 
emergency procedures directly by CAH staff. This will allow CAHs to 
provide such services under arrangement.
    Clarifying Changes: We have clarified several requirements in the 
hospital and CAH CoPs to ensure that they are consistent with the 
statute as well as with other, more current CoP requirements.
     Pharmaceutical Services: We have made a technical change 
to replace the term ``quality assurance program'' with the more current 
term ``quality assessment and performance improvement program.''
     Infection Control: We have made a technical change to 
replace the term ``quality assurance program'' with the more current 
term ``quality assessment and performance improvement program.''
     CAH Personnel Qualifications: We have aligned the 
definition of ``clinical nurse specialist'' that is in the rule with 
the definition that is in the statute.
     CAH Surgical Services: We have clarified that ``surgical 
services'' are an optional service for CAHs.
    Other Options Considered: We discussed alternative options for 
revisions that we considered, but did not propose. In the proposed 
rule, we also solicited comments and suggestions from both stakeholders 
and the general public on additional reforms that would reduce burden 
on hospitals and CAHs. In this rule, we have included our responses to 
the comments received on those alternatives, as well as a summary of 
additional recommendations submitted by commenters.

C. Summary of Costs and Benefits

1. Overall Impact
    The rule will reduce the total regulatory burden for hospitals and 
CAHs by nearly $940 million initially and by almost $5 billion over the 
next five years. Changes to the following CoPs accounted for the 
greatest potential savings in the final rule: Sec.  482.22, Medical 
staff ($330 million); Sec.  482.23, Nursing services ($110 million); 
Sec.  482.24, Medical record services ($170 million); and Sec.  482.54, 
Outpatient services ($300 million). Our estimates were based on input 
from stakeholders as well as on our own experience with hospitals.
    The potential savings will be achieved through a number of 
significant regulatory changes. For example, changes to the Medical 
staff CoP will allow hospitals to broaden the concept of ``medical 
staff'' through the appointment of non-physician practitioners to the 
medical staff so that they may perform the duties for which they are 
qualified through training and education and as allowed within their 
State scope-of-practice laws. For hospitals that choose this option, 
significant savings might be achieved as non-physician practitioners 
will enable physicians to more effectively manage their time so that 
they may focus on the more medically complex patients. Changes to the 
Nursing services CoP will allow hospitals to have a stand-alone nursing 
care plan or a single interdisciplinary care plan that addresses 
nursing and other disciplines. Providing hospitals with the option for 
a single, interdisciplinary care plan for each patient that addresses 
nursing and other disciplines, will not only support and improve the 
coordination of patient care, it will also result in significant cost 
reductions and efficiencies.
    The revisions will also allow hospitals much greater flexibility 
and freedom to determine the best ways to oversee and manage 
outpatients by removing the outdated requirement for a single Director 
of Outpatient Services. This simple, but necessary change to the 
Outpatient services CoP will bring hospitals both cost savings and more 
efficient ways to manage hospital resources. Finally, we will now allow 
CAHs to provide diagnostic and therapeutic services, laboratory 
services, radiology services, and emergency procedures under 
arrangement. For these small hospitals, this change will not only allow 
them to solve some of their pressing staffing problems in these service 
areas, it will allow them to increase access to these critical services 
for their patient populations.
    While we feel confident that our estimates reflect a reasonable 
approach to hospital and CAH cost savings, much will depend on the 
future staffing and management decisions that individual hospitals and 
CAHs choose to make.
2. Section-by-Section Economic Impact Estimates for 2012

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                                                                                      Annual         Five year
                                                                      Section      savings  ($M)   savings  ($M)
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Patient's Rights--Eliminate and replace burdensome reporting             482.13             $5.1           $25.5
 process for deaths involving only soft wrist restraints........
Medical Staff--Flexibility to consider other practitioners as            482.22            330.0         1,650.0
 eligible candidates for the medical staff......................
Nursing Services--Eliminate requirement for nursing care plan            482.23            110.0           550.0
 when an interdisciplinary plan is already in place.............
Medical Record Services--Less burdensome process to authenticate         482.24             80.0           400.0
 verbal orders..................................................
Medical Record Services--Allow the use of pre-printed and                482.24             90.0           450.0
 electronic standing orders for patient orders..................
Infection Control--Eliminate log of incidents related to                 482.42              6.6            33.0
 infections and communicable diseases...........................
Outpatient Services--Allow one or more individuals to be                 482.54            300.0         1,500.0
 responsible for the supervision of outpatient services.........
Transplant Organ recovery--Remove duplicative blood typing               482.92              0.2             1.0
 requirement....................................................

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CAH Provision of Services--Eliminate the requirement that                485.635            15.8            79.0
 certain services be provided only by employees and not through
 contractual arrangements with entities such as community
 physicians, laboratories, or radiology services................
                                                                 -----------------------------------------------
    Total.......................................................  ..............           937.7         4,688.5
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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
CNS Certified Nurse Specialist
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
IG Interpretive Guidelines
IOM Institute of Medicine
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
SOM State Operations Manual
TJC The Joint Commission
UMRA Unfunded Mandates Reform Act

Table of Contents

    This final rule is organized as follows:

I. Background
    A. Introduction
    B. Statutory and Regulatory Authority for Hospital CoPs
II. Provisions of the Proposed Rule and Response to Comments
    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)
    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. Provisions of the Final Rule
IV. Collection of Information Requirements
V. Regulatory Impacts

I. Background

A. Introduction

    This final 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 final rule we seek to 
reduce the regulatory burden placed on hospitals. We have identified a 
number of existing hospital Conditions of Participations (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. The January 2011 Executive 
Order directs 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 provisions of this final rule are intended to meet 
the letter and spirit of Executive Order 13563, 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.

B. Statutory and Regulatory Authority for 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), 42 CFR 440.20(a)(3)(ii), and 
42 CFR 440.140, 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 drive (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.

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    The CoPs are organized according to the types of services a 
hospital may offer, and include specific 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.).

II. Provisions of the Proposed Rule and Response to Comments

    On October 24, 2011, we published a proposed rule entitled ``Reform 
of Hospital and Critical Access Hospital Conditions of Participation'' 
(76 FR 65891). The proposed rule identified several priority areas in 
the CoPs for both hospitals (42 CFR Part 482) and CAHs (42 CFR Part 
485) and set forth revisions intended to eliminate or significantly 
reduce those instances where the CoPs are duplicative, unnecessary, 
and/or burdensome.
    We received approximately 1,729 public comments in response to the 
proposed rule. Many comments were supportive; however, there were some 
commenters that opposed the proposed provisions. Approximately 1,100 of 
the comments were part of a write-in campaign from anesthesiologists 
that supported what they described as CMS' upholding of physician 
supervision requirements, but objected to what the letters described as 
an effort to replace physicians with nurses.
    In general, the comments can be classified into roughly three 
categories: comments from hospitals, comments from physicians, and 
those from non-physician practitioners. Commenters representing the 
hospital industry, as well as accrediting organizations, expressed 
overwhelming support for the proposals and agreement with our efforts 
to bring the CoPs in line with current medical practice, eliminate 
burdensome and obsolete requirements, and provide hospitals with 
operational flexibility. Physician groups mostly disagreed with 
staffing proposals, and expressed disagreement with what they viewed as 
the Agency's endorsement of the replacement of physicians with nurses 
and non-physician practitioners. While commenters representing non-
physician practitioners expressed support for most of the proposals, 
they urged us to go further with changes that they believe would allow 
them to practice to the full extent allowed under their respective 
State laws and regulations. In the following section, we provide a 
brief summary of the proposed provisions, followed by responses to 
public comments received on each issue. For a detailed discussion of 
the proposals, see the October 24, 2011 proposed rule (76 FR 65891).

A. Revisions To Allow Flexibility and Eliminate Burdensome CoPs

1. Governing Body (Sec.  482.12)
    We proposed 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 
proposed to revise the introductory text of Sec.  482.12 to state that 
``There must be an effective governing body that is legally responsible 
for the conduct of the hospital.'' We noted that 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.
    Comment: Many commenters wrote in support of the CMS proposal to 
allow a single governing body for all hospitals within a multi-hospital 
system and they characterized the current requirement for a separate 
governing body for each hospital as redundant and obsolete. Several 
comments suggested the change would provide hospitals with greater 
flexibility and help them operate more efficiently and effectively. 
Others noted that the change would simplify governance and 
administrative processes. These commenters also suggested the change 
would enhance the continuity and consistency of policies and practices 
across all hospitals within a multi-hospital system. One commenter 
suggested the change might streamline the workflow for nurses. Many 
commenters also remarked that the proposal was appropriate given the 
more integrated organizational models adopted by many hospitals.
    Some comments detailed the greater efficiencies and cost savings 
that would result, including savings in areas such as finance, human 
resources, information technology, and purchasing. Many commenters 
specifically remarked that the change would end the redundant and 
inefficient practice of multi-hospital systems' holding duplicative, 
separate meetings for each of the hospital boards.
    Some comments stressed the advantages that a single governing body 
would have in terms of enhancing mutual accountability, interdependence 
and timely oversight. Commenters remarked that the single governing 
body structure could facilitate shared learning, promulgation of best 
practices and help hospitals standardize performance metrics and 
eliminate variances. Another commenter stated that its policy of 
allowing a single governing body for a multi-hospital system has not 
had an adverse impact on quality and safety.
    Response: We agree with the commenters that this change will 
positively affect hospitals. With the addition of a few changes 
pertaining to board membership, discussed below, we are finalizing this 
proposal for a single governing body. We will be finalizing the 
proposed language that refers to a hospital, generally, and removing 
the language referring to the hospital ``as an institution.''
    Comment: Several commenters requested that CMS specify in 
regulatory text that, ``hospital systems with more than one CMS 
Certification Number may have a single governing body.''
    Response: While we agree with the commenters' intent, and we 
recognize that the language suggested was excerpted from the preamble 
text of our proposed rule, we are not making this change in regulatory 
text. Rather, we will address this clarification in forthcoming sub-
regulatory guidance. Our decision against using the term ``CMS 
Certification Number'' in the final regulatory text is merely a 
precaution intended to provide flexibility, should the terminology be 
changed.
    Comment: Several commenters requested that CMS take a stronger 
position in favor of hospitals' adoption of a single governing body for 
their multi-hospital systems. Specifically, these commenters asked CMS 
to expressly state that, ``multi-hospital systems can be effectively 
led by a single governing body.'' On the other hand, we received 
comments requesting that CMS expressly state that ``multiple

[[Page 29038]]

hospitals cannot be effectively governed by a single governing body'' 
and that ``each hospital, including hospitals in a multi-hospital 
system, should have its own governing body.'' Still other commenters 
asked CMS to reaffirm the important role of local sub-boards.
    Response: While we believe that multi-hospital systems might gain 
important efficiencies and achieve significant progress in quality 
programs under the governance of a single governing body, we also agree 
that local sub-boards might be a valuable resource in hospital 
governance. We believe there is an important and essential symbiotic 
relationship that should exist between a hospital's governing body and 
its medical staff. The dynamics of this relationship generate critical 
checks and balances that serve to promote and protect patient health 
and safety. We believe that the ongoing, timely communication between a 
governing body and its medical staff is essential to the successful 
coordination and advancement of patient care, regardless of whether the 
adopted governance model is one of a single governing body for all 
hospitals in a multi-hospital system, one of a single governing body 
with local sub-boards at each hospital in the system, or one of a 
separate governing body for each hospital. The intent of the proposed 
revision was to provide hospitals with some regulatory flexibility with 
regard to hospital governance and to acknowledge that alternative 
methods of governance exist that might prove as effective as the 
traditional methods currently required by the CoP. When practically 
applied in the ``real world'' of hospitals, each model of hospital 
governance has the potential to be flawed and dysfunctional just as 
each has the potential to be engaged and effective. We remind the 
commenters that the proposed revision to this requirement is an option 
that each multi-hospital system is free to choose or not to choose for 
itself. Because we have not seen sufficient evidence presented that 
would indicate that one model works more effectively than another, we 
do not believe that it would be appropriate for CMS to endorse one 
model of hospital governance over another.
    Comment: Several of the commenters who expressed a clear preference 
for a hospital-specific governing body asked CMS to require that, at 
minimum, a member of the medical staff serve on the governing body. The 
commenters suggested that CMS' proposal to allow for a single governing 
body within a multi-hospital system would diminish communication and 
coordination between the governing body and the medical staff as it 
presently takes place at the individual hospital level. Commenters 
stated that an effective governing body needs to have an informed 
understanding of the care coordination challenges at each member 
hospital and that this can only be achieved when the lines of 
communication are open between the governing body and the medical 
staff.
    To counter the potential disruption of communication that may be 
caused by the proposal to allow multi-hospital governing bodies, 
commenters suggested that CMS require that a member of the medical 
staff serve on the governing body. Commenters added that such a model 
would further inform patient health and safety initiatives within the 
hospital.
    Commenters also expressed concern that, even under the current 
requirements which require a governing body at each institution, 
hospital physicians are generally not well represented on hospital 
governing bodies. Commenters stressed the importance of physician input 
at the governing body level, particularly as they believe it is 
essential in the context of CMS' proposal to permit a single governing 
body for a multi-hospital system.
    Response: We agree with the commenters' suggestion, and we are 
modifying our final regulatory language to require that a hospital's 
governing body must include at least one medical staff member. We agree 
with the commenters that strong coordination between a hospital's 
governing body and medical staff is paramount to the delivery of 
quality care.
    We note that these two, separate Conditions of Participation at 
Sec.  482.12 (Governing body) and Sec.  482.22 (Medical staff) have a 
long, overlapping, and interrelated history. In 1986, CMS discontinued 
a requirement for a joint committee to formalize liaison between the 
medical staff and the hospital's administration. At that time, we 
decided to leave decisions about liaison and coordination activities to 
internal hospital management (51 FR 22010, 22017, June 17, 1986). 
Because we are now making changes to the hospital's management 
structure by allowing a single governing body for multiple hospitals 
within a system, we believe that, in accordance with the comments we 
received on medical staff representation on the governing body, a 
formalized link between these interdependent entities is appropriate. 
While it may already be a requirement at some hospitals or simply a 
convention that others follow, we are not aware that this linked 
structure is the norm. We believe that adding the requirement for 
hospitals to have a medical staff member serve on the governing body 
will build in an important element of continuity and ensure regular 
communication between a hospital's governing body and its medical 
staff(s), particularly in light of our decision to permit a single 
governing body for hospitals in multi-hospital systems.
    We also believe that requiring a hospital's governing body to 
include a medical staff member will directly address a widely voiced 
concern for stronger communication between a hospital governing body 
and the medical staffs of its member hospitals. In the case of a multi-
hospital system with one governing body, we wish to clarify that we are 
not requiring that the governing body include a member of each 
separately certified hospital's medical staff, so long as at least one 
governing body member is a member of the medical staff of one system 
hospital. The governing body is free to select as many of its members 
from its medical staff(s) as it chooses. However, we would expect a 
multi-hospital system's single governing body to carefully consider the 
unique needs of the patient populations served by each of its member 
hospitals and their medical staffs when determining the number and 
composition of medical staff members to be appointed to the governing 
body. We recognize that physicians may be in a minority position on a 
hospital governing body even with this new requirement. That said, we 
believe that a physician who specifically represents medical staff 
members will hold some measure of enhanced standing within the 
governing body.
    Comment: We received numerous comments opposing our proposal for a 
single governing body. Many of these comments came from State and 
national physician associations as well as from a number of community 
hospitals. In particular, comments opposing a single governing body 
expressed concern that such a structure would further weaken governing 
boards' understanding of the daily operations and medical staff affairs 
of each hospital and thereby lead to a reduction in both the quality of 
care and patient safety protections. One community health network 
reported that it had seen ``remote management'' lead to waste of 
resources in the healthcare delivery system.
    Some commenters expressed particular concern about the implications 
that a single governing body would have in a hospital system comprised 
of diverse institutions. For example, commenters stated that a

[[Page 29039]]

single hospital system can encompass remote, rural areas as well as 
urban and suburban areas, and may also include specialty hospitals, 
such as a pediatric hospital. The commenters suggested that, if 
hospital systems like these moved to governance by a single, 
overarching governing body, a single body would not be able to properly 
address the needs of each separate hospital, particularly the needs of 
any hospital especially different from others in the system.
    Some commenters suggested that a single governing body would be 
more appropriate to large hospital systems with similar hospital 
members and that CMS should pare back its proposal by only making the 
single body option available in certain cases, to be limited by 
geography or specialty.
    A number of commenters opposed our proposal on the grounds that it 
could prove problematic for non-profit hospitals in light of the new 
requirements for these hospitals that are included in section 9007(a) 
of the Affordable Care Act (ACA). The commenters pointed out that this 
section of ACA revised section 501(r) of the Internal Revenue Code (26 
U.S.C.A. Sec.  501(r)) to require a non-profit hospital to establish 
and maintain their tax-exempt status by, among other things, conducting 
a community health needs assessment every three years. They stated that 
a non-profit hospital would not be able to conduct this required 
assessment through its own governing body (which they see as ``the 
natural convener of this activity in conjunction with the medical 
staff'') since they believe that our proposed governing body 
requirement, if finalized, may cause the hospital to lose its own 
governing body and be under the governance of a multi-hospital system's 
single governing body. The commenters also cited the requirements at 
Sec.  501(c)(3) of the Internal Revenue Code regarding the tax-exempt 
status of non-profit hospitals and they stated that in order to meet 
the requirements of this section, a hospital must demonstrate that it 
provides a community benefit, which is defined by Internal Revenue 
Service (IRS) guidance as ``based on part on whether a wide range of 
members of the community have a seat on the governance board.'' The 
commenters stated that they believe ``CMS' proposal to allow a single 
governing body for a multi-hospital system that is divorced from the 
very community it is meant to represent'' would prevent these non-
profit hospitals from meeting not only this IRS threshold for tax 
exemption, but also other State-specific requirements for tax-exempt 
status.
    Response: We appreciate the concerns of the commenters. We do not 
believe that a multi-hospital system's governing body can properly 
function without its gathering information and input from the 
administrative and medical staff of each member hospital, or from the 
local sub-boards if the system utilizes this model for hospital 
governance. We note that the regulations, as finalized here, are 
intended to provide multi-hospital systems with an option, but not a 
requirement, to use a single governing body. In those instances where a 
system believes that its interests are best served by using a single 
governing body, under the new CMS regulations, that system will have 
the flexibility to do so, just as another multi-hospital system will 
have the flexibility to continue following the current requirement for 
a separate governing body for each hospital in its system if it 
determines that course would best serve its interests.
    Comment: Several commenters asked CMS for clarity as to how a 
single governing body would operate within a multi-hospital system 
spanning different States.
    Response: We would expect multi-hospital systems to follow the 
laws, regulations, and local ordinances of the States in which each 
member hospital operates. A hospital system's adoption of a single 
governing body, as permitted under this revised federal regulation, 
would not in any way preempt any relevant State requirements. Hospitals 
must continue to comply with all applicable State and local laws.
    Comment: We also received a number of comments that asked how the 
new option for a single governing body would be implemented. One 
commenter asked how this would work for a multi-hospital system 
composed of more than one corporate entity. Another commenter asked 
whether survey decisions at each member hospital would be independent 
and whether this would impact the status of separately licensed, 
separately participating member hospitals in the system. Another 
commenter inquired about the integration of CAHs within a multi-
hospital system, asking whether the proposal would allow for a system 
with both CAHs and hospitals to have one governing body or for systems 
with differing payment structures. Finally, we were asked to clarify 
between the CMS governance standard at Sec.  482.12 and the 
requirements pertaining to co-located hospitals.
    Response: We note that permitting a single governing body for 
multiple hospitals in a system does not relieve each separately 
certified hospital from the obligation to separately demonstrate its 
compliance with all of the hospital CoPs. Each separately certified 
hospital will continue to be separately, independently assessed for its 
compliance, through either State Survey Agency or approved national 
accreditation program surveys. Several of the commenters' statements 
suggested that there may have been some confusion around this point.
    We offer hospital facilities considerable flexibility regarding how 
and whether they choose to participate in the Medicare program. Based 
on the geographic and other institutional limitations set out in our 
``provider-based'' regulation at Sec.  413.65, which addresses 
provider-based status for hospital facilities in multiple locations, 
hospital governing bodies make business decisions about how they want 
to participate in Medicare, and they indicate on their Medicare 
enrollment application the choices they have made. It is not uncommon 
to find multiple hospital campuses with one owner located in the same 
general geographic area enrolled in Medicare as one hospital. It also 
is not uncommon to see a hospital system choosing to enroll its various 
facilities as separate hospitals, even where their geographic proximity 
would permit them to be enrolled as one hospital. We are aware that 
various factors enter into consideration when governing bodies make 
these business decisions. For example, some governing bodies prefer to 
enroll various campuses as separate hospitals, out of a concern that 
problems at one hospital's campus might jeopardize the Medicare 
participation of the other campuses if they were a multi-campus 
hospital covered under one Medicare provider agreement. In other cases, 
a governing body may see the benefits of integrating medical and 
nursing staff of multiple campuses into one integrated hospital. In 
still other cases, the deciding factor might be the implications for 
Medicare reimbursement of graduate medical education, the ease of 
adding satellite locations, etc. We defer to the governing bodies of 
hospitals to weigh the pertinent factors, the permissible options, and 
to make business decisions in their best interests when applying to 
participate in Medicare.
    Our hospital certification decisions and issuance of a provider 
agreement and CMS Certification Number (CCN) follow from these business 
decisions by a hospital's governing body. We often certify as one 
``hospital'' entities whose locations are identified on the application 
as one primary location and one or more ``provider-based'' satellite 
locations, and issue one provider agreement to that hospital. Once so

[[Page 29040]]

certified, the resulting ``hospital'' must then separately demonstrate 
its compliance with the hospital CoPs, independent of any other 
facility. While a system consisting of multiple, separately certified 
hospitals with a single governing body may promote similar, or even 
identical, compliance policies across its separately certified member 
hospitals, it must make clear which hospitals the policies apply to, 
and each separately certified hospital is accountable for implementing 
the applicable policies, including securing the policy approvals of its 
separate medical staff where required under the regulations. As an 
example, we could envision a hospital system with a single governing 
body establishing a uniform approach to developing hospital quality 
assessment and performance improvement (QAPI) programs. The system 
might even choose to measure some common quality indicators and pursue 
similar performance improvement activities and projects across its 
member hospitals. However, each member hospital would be responsible 
for maintaining and making available to us evidence of its hospital-
specific QAPI program; presentation of only system-level information 
would not be acceptable.
    With respect to the commenter's statement about separate licensure, 
we are unclear as to what clarification the commenter is seeking, but 
we note that Sec.  413.65(d)(1) addresses State licensure requirements 
in order for facilities to be provider-based to a hospital's main 
campus. Those regulations provide for flexibility where separate 
licenses are required under State law.
    A CAH must be separately evaluated for its compliance with the CAH 
CoPs found in 42 CFR Part 485, Subpart F. It would not be possible to 
evaluate the CAH's compliance as part of an evaluation of a hospital's 
compliance. However, this does not preclude a multi-hospital system's 
single governing body from also serving as the CAH's governing body, so 
long as the governing body clearly identifies the policies and 
decisions that are applicable to the CAH.
    We recognize the importance of these inquiries and will address 
these in more detail in forthcoming interpretive guidance (IG) after 
the publication of this final rule.
2. Patient's Rights (Sec.  482.13)
    Section 482.13(g) requires hospitals to report deaths associated 
with the use of seclusion or restraint. We proposed 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)(2), we proposed that 
hospitals would be required to report to CMS the type of deaths 
described here (those involving soft two-point wrist restraints and no 
use of seclusion) by having hospital staff record the information about 
the death into a log or other system. At Sec.  482.13(g)(4), we 
proposed that each entry in the record must be made no later than seven 
days after the date of death of the patient and that the record must 
include the patient's name, date of birth, date of death, attending 
physician, primary diagnosis(es), and medical record number. We also 
proposed that hospitals must make this information available to CMS in 
either written or electronic form immediately upon request.
    For deaths involving all other types of restraints and all forms of 
seclusion, we noted that we would retain the current, more extensive 
death reporting requirements to CMS by telephone no later than the 
close of business on the next business day following knowledge of the 
patient's death. In addition to reporting the deaths by telephone, we 
proposed to revise Sec.  482.13(g)(1) to provide additional reporting 
options, which would include the use of facsimile and electronic 
reporting.
    Comment: Many commenters favored the proposal 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. The favorable comments included those received from 
individual clinical professionals, hospitals and hospital associations, 
large healthcare systems, and several nursing groups. Several other 
commenters agreed with the revisions but recommended that the required 
logs be made publicly available.
    Response: We appreciate the comments supporting the proposed change 
and the comments that suggested we add additional requirements and 
oversight. Changing the current reporting requirement to one that 
requires hospital staff to enter information into a log or other system 
those patient deaths that involve the use of only soft two-point wrist 
restraints will reduce unnecessary burden without negatively impacting 
patient safety. We believe the change will represent a welcome 
reduction in burden for hospitals and their staff, particularly in 
settings with a large number of patients in intensive care.
    We disagree with adding new requirements for hospitals to publicize 
the details from the log (or other system). The log will contain 
protected health information from the patient's medical record, such as 
the patient's name, date of birth, and primary diagnosis, all of which 
are protected by the Health Insurance Portability and Accountability 
Act (HIPAA) Privacy Rule found at 45 CFR part 160 and part 164, 
subparts A and E. To further clarify that the method of reporting these 
deaths will be a hospital's maintenance of a log (or other system), to 
which a hospital must make an entry no later than seven days after an 
applicable patient's death, we are adding the word ``internal'' 
preceding ``log or other system'' in this final rule. We believe that 
this will clarify and emphasize that the log, or system that a hospital 
chooses to utilize for its reporting of these types of deaths, is one 
that will be maintained internally by the hospital and that CMS is not 
requiring public release of information about such deaths nor are we 
requiring hospitals to submit the information in the internal log (or 
other system) to CMS. However, in this final rule, hospitals will be 
required to make the information contained in the internal log or other 
system immediately available to CMS upon request as was initially 
proposed.
    As discussed below, it is also important to remember that not all 
deaths of patients who die while in restraints, or shortly after their 
removal, are associated with the use of restraints. This is especially 
true in the context of soft two-point wrist restraints, which we note 
are often applied to acutely ill and medically unstable patients, prior 
to their eventual death, in order to prevent inadvertent patient 
removal of life-sustaining devices such as central lines and 
endotracheal tubes. The use of restraints in these cases is incidental 
to the patient's death and is not the cause of that death. Therefore, 
we do not believe that making public the information in the internal 
log (or other system) would contribute to ongoing quality improvement 
efforts.
    Comment: Some commenters wanted CMS to require hospitals to make 
the data available to protection and advocacy (P&A) agencies and to 
report the deaths to P&As as well as to CMS using a log or other 
system, as set forth at proposed Sec.  482.13(g)(4). A few commenters 
called for CMS to require hospitals to provide P&As access to the 
hospitals' logs specifically in accordance with applicable federal and 
State laws. Some commenters further requested that CMS create an 
explicit reference in Sec.  482.13 to the Developmental Disabilities 
Assistance and Bill of Rights Act of 2000, particularly with respect to 
the role of P&A agencies and their access to

[[Page 29041]]

information concerning the deaths of disabled individuals.
    Many commenters urged CMS to continue working to prevent future 
deaths by improving the data collection and analysis of restraint- and 
seclusion-related deaths, including those reported using the log or 
other system.
    Response: We believe that data collection and analysis will be 
greatly improved by making changes to the way hospitals report data to 
CMS, and, at this time, we do not believe that expanding the 
requirements beyond what we have proposed would improve patient safety.
    We are always looking for ways to improve and to increase the 
efficiency of communication that already occurs between CMS and P&As. 
We believe that the current, extensive reporting requirements may have 
impeded data collection and analysis. Adjusting the reporting 
requirements for a significant subset of restraint-related deaths, 
where only soft, two-point wrist restraints were used, will help to 
streamline data collection and sharpen our analytical focus.
    Finally, we decline the commenters' request for an explicit 
reference to the Developmental Disabilities Assistance and Bill of 
Rights Act, as we believe such a reference is inappropriate in Sec.  
482.13. We note that the Conditions of Participation at Sec.  482.11(a) 
already requires compliance with applicable Federal laws related to 
health and safety of patients, and we expect hospitals to ensure that 
any such requirements are met. However, as a practical matter, we must 
stress that CMS does not enforce other agencies' laws or rules, as 
would be the case with the above-referenced statute. CMS would only 
cite the facility for noncompliance with the aforementioned CoP at 
Sec.  482.11 if the agency having jurisdiction makes a final 
determination that there was a violation.
    Comment: Some commenters requested that CMS expand the proposed 
reporting requirements at Sec.  482.13(g)(4)(ii) by requiring hospitals 
to also record the length of time the patient was kept in the 
restraints as well as the reasons for and consequences of the restraint 
use.
    Response: We are requiring that hospitals document the patient's 
primary diagnoses along with the medical record number and other 
details. We believe that the data recorded in the internal logs will be 
sufficiently rich to conduct analysis of deaths where only soft, two-
point wrist restraints were used. We do not believe that additional 
descriptions around the use of the restraints are necessary at this 
time. As we have stated elsewhere in this discussion and in our 
proposed rule, we are 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.
    Comment: Some commenters suggested flexibility in reporting the 
deaths involving soft two-point restraints. They recommended that we 
allow for fax and electronic reporting of soft two-point restraint 
deaths.
    Response: We proposed that hospitals must maintain a log or other 
system of deaths involving only soft two-point restraints that can be 
made available to CMS immediately upon request, and that the required 
information about these deaths must be entered into the log no later 
than seven days after the date of the death of the patient. The words 
``log or other system'' at Sec.  482.13(g)(2) were chosen to create 
flexibility, such that a hospital could adopt a written or electronic 
means of tracking these deaths. However, since we did not propose to 
require hospitals to submit these reports to CMS, except upon request, 
we wish to clarify that routine faxing and electronic reporting of the 
deaths at Sec.  482.13(g)(2) directly to CMS is not necessary. Finally, 
we would note that the regulatory text now adds significant flexibility 
to the reporting options at Sec.  482.13(g)(1) for all other deaths, 
permitting such reports to be made ``by telephone, facsimile, or 
electronically, as determined by CMS.''
    Comment: One commenter recommended that we revise the overall 
requirement for death reporting in this rule. Two other commenters 
stated that the reporting requirements should be in accordance with 
State law. One commenter stated that reporting all deaths of patients 
who were restrained does not produce an accurate number of deaths 
caused by restraints. The commenter also noted that some patients may 
be near death when they are put into restraints and recommended that we 
clarify in the final rule that these individuals should not be included 
in the reporting requirement.
    Response: The requirements for reporting deaths of persons who were 
placed in restraints and/or seclusion were established by section 3207 
of the Children's Health Act of 2000 (Pub. L. 106-310, codified as 
section 592 of the Public Health Service Act (42 U.S.C.A. 290ii-1). 
Eliminating all reporting for this class of restraint deaths and 
relying on State law would be contrary to federal law, which requires 
hospitals and many other categories of healthcare facilities to report 
all restraint-related deaths. As stated in the proposed rule, we 
believe that a regulation requiring hospital staff to record 
information regarding the patient death into a log or other system (and 
which is made available to CMS immediately upon request) is entirely 
appropriate for these types of patient deaths and that it will satisfy 
this requirement for reporting deaths involving soft two-point 
restraints.
    Regarding which restraint deaths that should be reported, we agree 
that not all deaths that occur while a patient is restrained are 
proximately caused by the restraints themselves, and we have proposed 
these revisions so as to reflect this fact (revising the reporting 
requirements for soft two-point restraints). In proposing this 
revision, we looked at all death reporting that is required of 
Medicare-participating hospitals. For deaths involving all other types 
of restraints and all forms of seclusion, we are retaining the current 
reporting requirements. We proposed to add flexibility to those 
requirements by allowing the reports to be faxed or submitted 
electronically.
    However, as we reviewed the public comments regarding these 
proposed revisions, it became apparent to us that our proposed language 
might still cause some confusion regarding which restraint deaths truly 
must be reported to CMS through the ongoing submission of data and 
which restraint deaths can be reported by recording the information in 
an internal log or other system that the hospital would make 
immediately available to CMS upon request. We came to the conclusion 
that the proposed regulatory language was still not sufficiently clear. 
We learned that, due to our use of the phrase ``report to CMS'' in 
proposed Sec.  482.13(g)(2), many hospitals assumed that they would 
still be required to report the information through submission of data 
to CMS for those deaths related to soft, two-point wrist restraints. 
This was not our intention and does not achieve our purpose of reducing 
unnecessary regulatory burden. Therefore, in this final rule we have 
revised the proposed language to delete the phrase, ``report to CMS,'' 
and now will require that for those deaths related only to soft, two-
point wrist restraints the hospital staff must record the information 
regarding the patient's death in an internal log or other system. We 
are finalizing as proposed the requirement that this information must 
be entered no later than seven days after the death and that the 
information in the internal log or other system must be made available 
to CMS immediately upon request in either written or

[[Page 29042]]

electronic form. We are also finalizing the requirement that each entry 
must document the patient's name, date of birth, date of death, name of 
attending physician or other licensed independent practitioner who is 
responsible for the care of the patient as specified under Sec.  
482.12(c), medical record number, and primary diagnosis(es).
    Additionally, and in order to maintain consistency with these 
changes, we are revising the regulatory language proposed at Sec.  
482.13(g)(3). The language finalized here revises paragraph (g)(3) to 
contain two separate provisions and will now require that hospital 
staff must document in the patient's medical record the date and time 
the death was: (1) Reported to CMS for deaths described in paragraph 
(g)(1) or (2) recorded in the internal log or other system for deaths 
described in paragraph (g)(2).
    Comment: Some commenters recommended that we have a common 
reporting system. They stated that all deaths should be reported 
consistently, in the same manner and within the same timeframe, by the 
close of the following business day. They stated that having two 
separate reporting mechanisms would be confusing and would upset the 
existing, well-established uniform reporting protocols.
    Some commenters quoted our responses in the 2006 final rule on 
Patient's Rights where we said ``a uniform definition of restraint 
across care settings is a good approach, adds clarity, and avoids 
confusion * * * This definition renders unnecessary the otherwise 
impossible task of naming each device and practices that can inhibit a 
patient's movement'' (71 FR 71388). These commenters suggested the CMS 
was disrupting this uniformity with the new revisions contained in this 
final rule.
    Another commenter suggested that the new requirement for an 
internal log or other system would be more burdensome than the present 
requirements for reporting the death to CMS by telephone. The commenter 
wondered whether the new requirements would mean the maintenance of a 
separate log by an assigned individual to research the patient's 
medical records to obtain all the necessary information. Another 
commenter asked whether the new requirement for an internal log would 
include hospital databases where reports could be generated and sent to 
CMS.
    Response: We believe that the commenters have taken the responses 
to comments in the 2006 final rule out of the context in which they 
were discussed, that is, a uniform definition of restraint. For the 
sake of clarity, we note that we have not made a change to the 
definition of ``restraint.'' We still maintain that ``a uniform 
definition of restraint across care settings'' is the best approach and 
we are not changing that in this rule. What we are finalizing is a 
change to the reporting requirements and not to the definition of 
restraint. We have received extensive feedback from those who would be 
implementing the new reporting requirements, and this feedback has 
largely been favorable.
    We believe the new requirements will relieve some burden on 
hospitals and their resources. We already expect hospitals to be 
tracking the details of deaths where the patient had been restrained by 
soft, two-point wrist restraints. Under the new requirements, this 
information will no longer need to be reported to CMS by telephone no 
later than the close of business the next business day following 
knowledge of the patient's death.
    As suggested by one commenter, the requirements for the internal 
log or other system could be satisfied by the maintenance of a database 
where reports could quickly be generated if requested by CMS.
    Comment: One commenter asked why a death that could be related to 
soft wrist restraints calls for less accountability and why a hospital 
could take a week to report the death.
    Response: Hospitals remain accountable for the appropriate medical 
treatment of their patients and for all deaths that occur in their 
facilities. Not all circumstances involving restraints and associated 
deaths are the same. As discussed in the proposed rule, critically ill 
patients are often restrained in soft two-point restraints to prevent 
them from removing life-saving tubes and lines. And as we have stated 
elsewhere in this discussion and in our proposed rule, we are 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. Since such deaths are incidental to the 
use of these types of restraint, we believe that the revised reporting 
requirements that we are finalizing here are appropriate to the goal of 
ensuring hospital accountability for patient safety without continuing 
to impose undue regulatory burden in these instances.
    Regarding the 7-day timeframe for documenting the entry about this 
type of patient death that we are finalizing in this rule, this 
modification affects only that segment of patient deaths where no 
seclusion is used and the only restraints used are soft, two-point 
wrist restraints. Even though this rule will allow for this timeframe, 
which we believe is entirely appropriate for those deaths where the use 
of restraints is incidental and not the cause of the patient's death, 
we do not expect a hospital to take the full seven days to document the 
entry on each of these deaths into its internal log or other system. 
Since the provision requires a hospital to provide the information in 
its internal log or other system to CMS immediately upon request, we 
would expect a hospital to enter the information as soon as possible in 
order to ensure that it has the most up-to-date information on these 
patient deaths in its system. However, to continue to require hospitals 
to report the deaths of these patients by the end of the next business 
day requires a significant amount of effort, and does not improve 
patient safety. Therefore, we are finalizing the 7-day timeframe 
requirement for documenting the entry in the log or other system as 
proposed.
    Comment: One commenter recommended that we require hospitals to 
retain the death reporting log for at least six years.
    Response: We disagree with requiring hospitals to retain the 
internal log for a minimum of six years, which, we note, is longer than 
the current requirements for medical records. However, State law may 
require longer periods of record retention for patient medical records 
or documents.
    Comment: Several commenters stated that having a time frame longer 
than 24 hours to submit information may be more effective at reducing 
burden than having two separate methods and timeframes. Still other 
commenters stated that having a longer timeframe to submit a report 
will not decrease burden.
    Response: We disagree with both comments. We believe that the 
proposed revisions to the death reporting requirement will provide 
flexibility to eliminate burden while ensuring patient safety. And we 
point out that the provision we are finalizing does not require the 
submission of information for the deaths related to soft, two-point 
wrist restraints only; the revised provision requires only the 
recording of information about these types of deaths in an internal log 
or other system.
    Comment: A commenter asked CMS to consider setting minimum 
timeframes for both the renewal of a restraint order and the monitoring 
of those patients in restraints who are non-violent or non-self 
destructive. The commenter suggested that undefined timeframes could 
exacerbate situations already

[[Page 29043]]

lacking in the practice of re-evaluations for continued restraint. The 
commenter also suggested that the absence of set timeframes contributes 
to problems concerning quality of care and patient autonomy and harms 
altruistic efforts, generally. The commenter stated that extended 
periods of restraint and seclusion pose a serious safety issue for non-
violent or non-self-destructive patients, including those in vulnerable 
populations, and advocated for greater standardization in the 
guidelines.
    Response: These comments are outside the scope of this rule. While 
we thank the commenter for his or her opinions on this matter, we have 
not seen any evidence that such requirements for these types of orders 
improve patient safety. We believe that establishing arbitrary minimum 
timeframes for the renewal of orders for both restraints and subsequent 
monitoring of non-violent, non-self destructive patients could impede a 
hospital's flexibility in establishing its own policies and procedures 
for these orders, based on what the hospital knows would best meet the 
needs of its specific patient populations. Additionally, timeframe 
requirements could also increase provider burden in this area if the 
CMS timeframes are more restrictive than a hospital's current practice.
    Comment: One commenter requested that CMS make a clarifying 
statement regarding the requirements at Sec.  482.13(e)(5) that would 
identify which practitioners may order restraint or seclusion. The 
commenter noted that the current requirements use the term ``licensed 
independent practitioner'' and that this has been interpreted by many 
to mean that a physician assistant may not order restraint and/or 
seclusion. The commenter expressed disagreement with these 
interpretations and suggested instead that, where permitted by State 
law, a physician could delegate the ordering of such measures to a 
physician assistant. The commenter requested that CMS provide a 
clarifying statement that (1) PAs are authorized to order restraint and 
seclusion and (2) are subject to training requirements.
    Response: The commenter is correct in pointing out that the current 
requirements use the term ``licensed independent practitioner.'' 
According to the State Operations Manual (SOM), the IGs for Sec.  
482.13(e)(5) state, ``For the purpose of ordering restraint or 
seclusion, an LIP is any practitioner permitted by State law and 
hospital policy as having the authority to independently order 
restraints or seclusion for patients.'' Therefore, if an individual PA 
was authorized by State law and hospital policy to independently order 
restraints or seclusion for patients, then that PA could do so within 
the hospital. However, since PAs have traditionally defined themselves 
as ``physician-dependent'' practitioners (as opposed to APRNs, who see 
themselves as independent practitioners), it is unlikely that a PA 
would be authorized by State law and hospital policy to 
``independently'' order restraints or seclusions for patients as would 
be likely for licensed independent practitioners such as physicians, 
APRNs, and clinical psychologists. The supervising physician-PA team 
concept (and PA practice dependence on the supervising physician) is 
supported by the American Academy of Physician Assistants' description 
of the PA profession: ``Physician assistants are health professionals 
licensed or, in the case of those employed by the federal government, 
credentialed to practice medicine with physician supervision'' 
(American Academy of Physician Assistants. (2009-2010). Policy Manual. 
Alexandria, VA.). Moreover, a PA would not be allowed to order 
restraints or seclusion if the only authority to do so was delegated by 
a physician since this physician-delegated authority would establish 
that the PA was not independently authorized by State law and hospital 
policy, which we stated is a prerequisite for this type of order.
    PAs (and RNs) are subject to the training requirements in this 
section, in addition to any special requirements specified by hospital 
policy associated with the one-hour face-to-face evaluation of a 
patient who is restrained or secluded for the management of violent or 
self-destructive behavior that jeopardizes the immediate physical 
safety of the patient, a staff member, or others.
    Comment: One commenter inquired whether a ``geri chair'' is 
considered a restraint that would require reporting according to the 
revised requirements.
    Response: The only reporting change we proposed concerns those 
deaths where no seclusion has been used and the only restraints used 
were soft two-point wrist restraints, as set forth at Sec.  
482.13(g)(2). Per current IG for Sec.  482.13(e)(1)(i)(A), found in the 
SOM (http://cms.hhs.gov/manuals/Downloads/som107ap_a_hospitals.pdf), 
a geri chair or a recliner could meet the definition of restraint only 
if the patient cannot easily remove the restraint appliance and get out 
of the chair on his or her own.
    Comment: One commenter inquired whether certain new types of 
restraints would be considered to fall within the ``soft'' two-point 
wrist restraint subset. The commenter described the material as made of 
nylon and a foam type of material, rather than the more commonly used 
cotton and wool materials, and that Velcro would be used to fasten 
them. The commenter also asked why CMS did not explicitly mention soft 
restraints which were applied to the ankles rather than a patient's 
wrists.
    Response: We would not expect hospitals to change their reporting 
method for deaths involving any restraints that could be described as 
hard and rigid, such as leather restraints.
    CMS has specifically revised the reporting requirements for soft 
two-point restraints that are used only on the wrists and not those 
that were applied to a patient's ankles or elsewhere on the body.
    We wish to stress that the restraints we are setting out for 
documenting in an internal log are those typically used in critical 
care settings, such as intensive care units, where such restraints are 
medically necessary. Soft two-point wrist restraints are commonly used 
to prevent patients from removing medically necessary devices and 
equipment such as central lines, endotracheal tubes, and nasogastric 
tubes.
    Comment: One commenter referenced a 2006 report, ``Hospital 
Reporting of Deaths Related to Restraint and Seclusion,'' published by 
the DHHS Office of Inspector General which found communications lapses 
among CMS, the Food and Drug Administration (FDA)--which monitors 
deaths associated with a medical device, Protection and Advocacy 
Agencies (P&As), and State survey agencies working on behalf of CMS. 
The commenter expressed concern about the OIG's findings, including its 
documenting of significant underreporting to CMS by hospitals of 
restraint- or seclusion-related deaths, as well as delays in reporting. 
The commenter inquired whether reporting delays had diminished since 
the report's publication.
    Response: We have limited data, but we believe that the current 
reporting requirements may actually exacerbate hospital underreporting 
or untimely reporting of deaths associated with restraint or seclusion. 
A review of data collected on deaths reported in May and in December of 
2007 indicated that only 13.5 percent of all types of hospitals 
nationally had submitted any reports during those two months. Between 
2008 and 2010 our Regional Offices entered into our survey and 
certification

[[Page 29044]]

database a sampling of reports, taking reports from two or three months 
in each of the years. We analyzed the data and found results consistent 
with a pattern of underreporting. At least for IPPS hospitals, which 
provide short-term acute care hospital services, and where soft wrist 
restraints are often used in critical care settings when patients are 
sedated and restrained for their own safety in order to preclude 
patient removal of items such as endotrachial tubes and central lines, 
we would have expected every such hospital to have had one or more 
cases per month of a patient who died while two-point soft wrist 
restraints were in use, or shortly thereafter. In fact, we received at 
least one report from only 41 percent of all IPPS and psychiatric 
hospitals during the sampled periods between 2008 and the present. 
Underreporting has proven to be an ongoing challenge under the current 
rule.
    We would also note that, since the great majority of death reports 
that hospitals do submit involve two-point soft wrist restraints only, 
most of the reports submitted to us are reviewed and filed without any 
further action, since we do not believe in such cases that the use of 
the two-point soft wrist restraint contributed to the patient's death. 
In such cases we believe it would not be an effective use of our 
limited survey resources to conduct an on-site investigation as a 
follow-up to a death report where only soft two-point wrist restraints 
had been used and where there was no evidence that the death was caused 
by the restraints used. It is not surprising that many hospitals might 
fail to perceive a linkage between the use of a two-point soft wrist 
restraint and a patient's death, and therefore the need to report such 
deaths to us as a death associated with the use of restraint or 
seclusion. We believe the revised reporting requirement will enhance 
patient safety by only requiring the prompt submission to us of a more 
narrow range of patient deaths where the likelihood of causation by the 
use of restraint or seclusion is greater. We also believe we will be 
able to address underreporting more effectively under the revised rule. 
We also believe the new regulatory requirement will better focus 
hospitals' attention and corrective efforts in these riskier areas.
    Comment: A commenter remarked that, in proposing the changes to 
reporting by hospitals, CMS did not discuss the data from deaths 
related to other types of restraints or seclusion.
    Response: We agree with the commenter's apparent suggestion that 
more study may be necessary to evaluate the impact from other types of 
restraints or seclusion. As in the drafting of this proposal, CMS has 
pursued a conservative, cautious approach before finalizing the new 
requirements. In the proposal, we stated at the onset that, ``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.'' As discussed above, in 
the context of the 2006 OIG report, ``Hospital Reporting of Deaths 
Related to Restraint and Seclusion,'' CMS has found this subset of 
restraint-related deaths to represent a substantial percentage of 
reported deaths to CMS. We do not believe there is a causal 
relationship between the use of soft two-point wrist restraints and 
patient deaths. Moreover, no public comments were submitted that 
provided any evidence or research to the contrary. We believe the new 
reporting requirements will allow CMS to focus more closely on data 
from deaths related to other types of restraints or seclusion where 
there is a greater likelihood of finding harm due to the restraints or 
seclusion.
    Comment: A commenter suggested that CMS should add language 
limiting its proposed change in the reporting requirements to the use 
of 2-point soft wrist restraints ``in intensive and critical care 
units'' and ``to prevent patients from removing medically necessary 
devices and equipment restraints.''
    Response: We believe that the revised reporting requirements are 
appropriate and that the commenter's suggested additions could be 
problematic. We agree that soft two-point wrist restraints are 
generally used in intensive and critical care units and that they are 
used to prevent patients from removing medically necessary devices and 
equipment restraints. However, we would not expect hospitals to limit 
the use of such restraints to intensive and critical care units alone.
    Comment: A commenter suggested that CMS change its proposed 
language to be more inclusive of non-physician providers. The commenter 
recommended that Sec.  482.13 (g)(4)(ii) be re-worded to read: Each 
entry must document the patient's name, date of birth, date of death, 
attending physician ``or other clinician's'' name, medical record 
number, and primary diagnoses.
    Response: We appreciate the commenter's suggestion. We agree that 
the proposed regulatory text does not take into consideration that 
patients who are not Medicare patients may be under the care of a non-
physician practitioner or licensed independent practitioner, as that 
term is used here, if allowed under State law and hospital policy. 
Therefore, we are making a change to the regulatory text at Sec.  
482.13(g)(4)(ii) so that it will now read, ``name of attending 
physician or other licensed independent practitioner who is responsible 
for the care of the patient as specified under Sec.  481.12(c).'' This 
will make the regulatory text here consistent with other provisions in 
this section. For Medicare patients, the requirements of Sec.  
482.12(c) will still apply.
3. Medical Staff (Sec.  482.22)
    The CMS CoP on ``Medical staff,'' at Sec.  482.22, concerns the 
organization and accountability of the hospital medical staff. We 
proposed three revisions to the Medical staff CoP.
    First, we proposed to redesignate Sec.  482.22(a)(2) as 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's scope-of-practice law, 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. Second, we also proposed to require that 
those physicians and non-physicians, that have been granted practice 
privileges within their scope of practice, but without appointment to 
the medical staff, are subject to the requirements contained within 
this section.
    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 the 
State in which the hospital is located, a doctor of dental surgery or 
dental medicine. We proposed to allow a hospital the option of also 
assigning the leadership of the medical staff to a doctor of podiatric 
medicine when permitted by the State law of the State in which the 
hospital is located.
    Comment: Overall, the majority of comments were overwhelmingly 
supportive of the proposed changes to the Medical staff CoP at Sec.  
482.22(a) that would broaden the concept of ``medical staff'' to 
include other practitioners who are granted hospital privileges to 
practice in the hospital in accordance with State law, not only those 
who are actually appointed to sit on the medical staff. However, a 
significant number of

[[Page 29045]]

commenters, while supportive of the proposed changes, recommended that 
CMS go further with its revisions in this area. Specifically, they 
would like to see the requirements finalized with these additional 
revisions incorporated into the regulatory text:
     Medical staffs must be representative of all types of 
health professionals who have privileges, including Advanced Practice 
Registered Nurses (APRNs) and Certified Nurse Midwives/Certified 
Midwives (CNMs/CMs), and who provide services to a hospital's patients, 
and as they are authorized to provide services under State law and to 
the extent of their full scope of practice;
     Non-physician members of the medical staff must be 
accorded the same rights and protections as physician members, 
including full voting privileges, membership on committees, ability to 
appeal, and due process;
     The credentialing and privileging process and the 
selection process for medical staff membership must be transparent and 
follow established criteria;
     Each application for privileges must be completely 
reviewed and a determination made within a 60-day period; and
     The applicant must be notified of the determination in 
writing with an explanation of the determination.
    One commenter asked for the ``specific inclusion of registered 
dieticians as non-physician practitioners included and affected by the 
proposed regulation.'' Another commenter voiced support for the 
proposal to allow hospitals to grant privileges to non-physicians, 
regardless of whether they are also appointed to the hospital's medical 
staff, but believed that expressly limiting the non-physician 
practitioner's scope of practice to what is allowed by the State in 
which the hospital is located (as we have proposed here) has the 
potential to greatly limit the value to be gained from that 
practitioner. The commenter stated further that it is well documented 
that more than half of the States have implemented regulations and 
restrictions that impede the full realization of the potential of 
APRNs, and that the quality of care by APRNs does not vary by State. 
The commenter affirmed that APRN care is of the same quality as that 
provided by physicians for the same services, and that there is no 
clinical reason for these variations in State scopes of practice. 
Finally, this commenter urged CMS to establish a standard that 
recognizes non-physician practitioners should be privileged to practice 
to the full extent of their professional education and capabilities by 
deleting the reference to State licensing in the proposed requirements. 
The commenter believes that this would be a way to break down 
unwarranted barriers to full utilization of APRNs and other non-
physician practitioners in hospitals and that such a change in the 
final rule would be consistent with recommendations in The Future of 
Nursing: Leading Change, Advancing Health (Institute of Medicine, 
October 2010). It should be noted here that many of the other 
commenters who asked for CMS to go further in the revisions to the 
medical staff requirements also cited this IOM report. The IOM report 
includes a recommendation specific to CMS, which urges that we amend or 
clarify our requirements to ensure that advanced practice registered 
nurses are eligible for clinical privileges, admitting privileges, and 
membership on medical staff.
    Conversely, we also received a significant number of comments from 
those who were adamantly opposed to the proposed changes. A majority of 
the dissenting opinions took the form of comments expressing serious 
concerns about allowing non-physician practitioners to obtain hospital 
privileges without becoming members of the medical staff. These 
commenters continued by stating that, ``allowing some providers to 
circumvent medical staff oversight will detrimentally impact patient 
safety and quality afforded to Medicare beneficiaries and all 
patients.''
    Many of the comments opposed to the proposed changes specifically 
focused on the proposal to allow physicians to be granted hospital 
practice privileges without requiring them to be appointed to the 
medical staff. The commenters stated that this proposed change would 
allow a hospital to exclude certain physicians from the medical staff, 
would effectively divide a hospital's physicians into two groups (those 
on the medical staff and those who are not), and would undermine what 
the commenters see as the medical staff's chief function: self-
governance. The commenters maintain that appointment to the medical 
staff provides a physician with a voice in the governance of the 
medical staff and patient care, including the specific needs of that 
physician's patient population. Further, the commenters stated that the 
medical staff appointment ``engenders a mutual responsibility for the 
activities and work of the medical staff--such as quality improvement--
promoting a mutual objective to oversee and protect the health and 
safety of patients.'' The commenters believe that this mutual objective 
of the medical staff is responsible for both professional standards and 
patient care.
    These same commenters believe that the proposed changes would allow 
hospitals to circumvent the protections that the medical staff bylaws 
provide for physicians (for example, judicial enforcement of any 
procedural rights contained in the bylaws). The commenters state that 
the changes ``could allow hospitals to avoid lawsuits by physicians who 
would otherwise be protected by the contractual relationship created by 
virtue of their appointment to the medical staff.'' In other words, the 
commenters believe that the protections afforded to physicians by the 
medical staff bylaws are only available to those physicians who are 
appointed to the medical staff and that merely being granted clinical 
privileges to practice is not enough to guarantee these protections.
    The commenters also voiced concern over what they saw in the 
proposed rule as an opportunity for hospitals to privilege physicians 
outside the authority of the medical staff. In their comments, they 
state that they are opposed to our proposal to allow a governing body 
to grant privileges in accordance with ``hospital policies and 
procedures,'' and not upon the recommendations of the medical staff 
``in accordance with medical staff bylaws, rules, and regulations,'' as 
is currently required in the regulations. They believe that, if 
allowed, this could have a negative impact on peer review of physicians 
in hospitals. The commenters expressed concern that those who are 
privileged but not appointed to the medical staff would not have the 
same due process protections of peer review accorded to members of the 
medical staff members. Commenters questioned whether these physicians 
would then be subject to a hospital-driven review process that is 
dictated only by a hospital's administration without any medical staff 
input or with input from only a few hospital-selected medical staff 
members. They also are concerned that a privileging process that is 
allowed to be un-tethered from the medical staff could lead to various 
fraudulent practices by hospitals to which the commenters are opposed. 
Examples cited by commenters include the practice of ``economic 
credentialing,'' which the commenters described as the use of economic 
criteria (for example, potential to generate the most revenue for the 
hospital based on increased referrals) unrelated to the quality of care 
or professional competence to determine a practitioner's qualifications 
for privileges, and ``horse trading,''

[[Page 29046]]

which they described as a practice whereby two or more hospitals 
informally agree on the privileging status of applicants based on the 
hospitals' mutual interests. The commenters requested clarification 
from CMS on all of these points and urged us to ensure that the 
proposed requirements would retain the authority of the medical staff, 
in accordance with its bylaws, rules, and regulations, to make medical 
staff appointment and privileging recommendations and that these 
changes would not hinder or obstruct medical staff peer review efforts. 
The commenters also encouraged CMS to look at the proposed regulatory 
language with regard to medical staff oversight of non-medical staff 
practitioners. They pointed out that there is no specific mention in 
the rule of the applicability of the medical staff bylaws and oversight 
to these types of practitioners, both physicians and non-physicians 
alike.
    With regard to the discussion of non-physician practitioners and 
medical staff privileges in the proposed rule, these same commenters 
objected to what they saw as ``CMS's explicit endorsement of the 
replacement of physicians with non-physician practitioners throughout 
the rule.'' They commented that they believe that CMS's stated intent 
of the revisions to the medical staff CoP was to replace physicians 
with non-physicians, and this would be ``contrary to the purpose of the 
CoPs, namely, to provide a safe hospital setting.'' While the 
commenters recognized the value that non-physician practitioners 
provide to the healthcare team, they maintained that physicians are the 
practitioners who are best qualified to lead that team, particularly in 
a hospital setting where patients are treated for complex and critical 
illnesses and injuries. They further objected to what they saw in the 
proposed rule as CMS' explicit encouragement of the expansion of scope 
of practice laws by States. The commenters pointed out that this 
conflicts with the express regulatory language of the proposed rule, 
which defers to existing State scope of practice laws, and they 
cautioned that any expansion of these laws should be based on a review 
of the evidence and on the training and education of non-physician 
practitioners to determine if such expansions are truly in the best 
interests of patient health and safety.
    Finally, the commenters urged CMS to consider their assertion that 
medical staff appointment and privileges are not ``either/or'' 
propositions. They pointed out that the American Medical Association 
(AMA) has long given its members guidance on medical staff categories 
of membership and cite the following examples: ``Active,'' 
``affiliate,'' ``administrative,'' ``call coverage,'' ``telemedicine,'' 
and ``temporary'' (Evolving Relationship between Hospitals and Medical 
Staff. Brian M. Peters, Esq. (2001). AHLA Seminar Materials. Post & 
Schell, PC). They stated that while these categories ``differ in their 
level of responsibility and oversight,'' the categories do ``share the 
comity of membership in the medical staff, which we believe engenders a 
shared accountability.'' While the commenters noted that CMS mentions 
medical staff categories in the preamble, they point out that most 
medical staffs already employ categories and these are specified in the 
medical staff bylaws. Again, the commenters urged CMS to remove its 
proposed requirement at Sec.  482.22 that would allow for the exclusion 
of some physicians from both the participation in, and the protections, 
of the medical staff.
    Response: We appreciate the support for the proposed changes. We 
also thank the commenters for their recommendations to make additional 
revisions to the medical staff requirements that would allow APRNs and 
other non-physician practitioners to practice to the full extent of 
their education and training. We have also noted the recommendations of 
the IOM report regarding our requirements and the eligibility of APRNs 
for hospital privileges and medical staff membership.
    Upon review of our proposed medical staff requirements and the 
public comments received, we realized that we might not have achieved 
what we originally intended with these changes, that is, to provide 
hospitals with the flexibility they would need to explore new 
approaches to care giving by allowing them the ability to increase the 
numbers and types of practitioners who could be granted hospital 
privileges to treat and care for patients. As we proposed in these 
revisions, any regulatory limits on these privileges would be imposed 
by the State licensing and scope-of-practice laws of the State in which 
the hospital is located. We sought to relieve regulatory burden by 
clarifying and revising the current requirements so that hospitals 
would still be allowed to appoint non-physician practitioners to their 
medical staffs, but that medical staff membership would not be a 
prerequisite to being granted privileges in the hospital, regardless of 
whether a practitioner was a physician or a non-physician. Based on the 
public comments received, we are revising our proposed Medical staff 
requirements in this final rule to better address the many valid issues 
that were raised by both those who supported this section of the 
proposed rule and those who opposed it.
    While we agree with the IOM report's recommendation that we amend 
our requirements to ensure that advanced practice registered nurses are 
eligible for hospital privileges and membership on medical staff, we 
respectfully disagree with the commenters' suggestions that we need to 
add additional requirements that would guarantee both non-physician 
practitioner representation on the medical staff as well as specific 
rights for those non-physician practitioners. In addition, we also 
disagree with the recommendations offered in the comments that we add 
very specific and highly prescriptive requirements pertaining to a 
hospital's credentialing and privileging process. The current 
requirements already provide for a transparent process based on 
established criteria. Although the current requirements provide a level 
of specific guidance to hospitals and their medical staffs regarding 
the privileging and medical staff appointment process, we do not 
believe that there is sufficient evidence to indicate that a hospital 
medical staff and, subsequently, patient health and safety would 
benefit from the addition of more rigid and prescriptive provisions, 
such as the commenters' specific recommendations to require a 60-day 
timeframe for a hospital to review and determine privileges for an 
individual practitioner applicant, or to require that the hospital 
notify the practitioner applicant in writing with an explanation of its 
determination.
    We also disagree with the one commenter's recommendation that we 
specifically include registered dieticians in the category of non-
physician practitioners affected by this rule. We assume that the 
commenter means that hospitals should be required to recognize 
registered dieticians as members of their medical staffs. We point out 
that the final rule does not specifically name any category of non-
physician practitioner in the regulatory text. While we frequently 
mentioned APRNs and PAs in our discussions regarding the composition of 
the medical staff in both the proposed and final rules, we have done 
this only because these categories of non-physician practitioners have 
scopes of practice within the hospital setting that are often second 
only to physicians in terms of how broad those scopes of practice are. 
For this reason, these categories of non-physician practitioners seem 
the most logical and

[[Page 29047]]

appropriate choices of categories eligible for appointment to a 
hospital's medical staff. The current requirements and the revisions 
contained in this rule are written to allow a hospital's governing body 
the greatest flexibility in determining which categories of non-
physician practitioners that it chooses to be eligible for appointment 
to the medical staff. Once the hospital's governing body determines 
which categories are eligible for appointment, the new requirements in 
this final rule will ensure that the medical staff examines the 
credentials of all eligible candidates and that it makes its 
recommendations for medical staff appointments to the governing body in 
accordance with State law, including scope-of-practice laws, and the 
medical staff bylaws, rules, and regulations. The rule is intended to 
encourage hospitals to be inclusive when they determine which 
categories of non-physician practitioners will be eligible for 
appointment to their medical staff. Under the new requirements, an 
individual hospital would be allowed to include registered dieticians 
as a category of non-physician practitioners eligible for medical staff 
appointment as long as their inclusion is in accordance with the laws 
of the State in which the hospital is located.
    We also respectfully disagree with the comments recommending that 
we use our rulemaking authority to recognize non-physician practitioner 
professional education and capabilities in our requirements by removing 
our deference to State licensing and scope of practice laws. As we 
stated in a recent rule addressing credentialing and privileging and 
telemedicine services, ``CMS recognizes that practitioner licensure 
laws and regulations have traditionally been, and continue to be, the 
provenance [sic] of individual States, and we are not seeking to pre-
empt State authority in this matter. We believe that the proposed 
requirements regarding State licensure leave room for the laws that 
exist today as well as any changes to these laws that may occur in the 
future, including any increase in the number of States that decide to 
engage in compacts, privilege to practice or reciprocity agreements, 
endorsements, and other arrangements regarding practitioner licensure 
(76 FR 25557).'' We would also note that generally, federal agencies do 
not issue rules preempting State law unless Congress explicitly or 
implicitly requires such preemption. Therefore, we will continue to 
defer to individual State practitioner licensing and scope of practice 
laws with regard to hospital privileges and medical staff appointments.
    Finally, we do not agree with commenters' assertion that our goal 
is to ``replace physicians with non-physicians.'' Our overall intent in 
revising the proposed requirements in this final rule continues to be 
what we initially expressed in the proposed rule, namely, to provide 
the flexibility that hospitals need under federal law to maximize their 
medical staff opportunities for all practitioners, particularly for 
non-physician practitioners, but within the regulatory boundaries of 
their State licensing and scope-of-practice laws. We believe the 
greater the flexibility that hospitals, medical staffs, and individual 
physicians have to enlist the services of non-physician practitioners 
to carry out the patient care duties for which they are trained and 
licensed, the better the quality of care will be for patients. 
Therefore, in this final rule, we are both modifying the proposed 
changes to the Medical staff requirements as well as revising portions 
of the current requirements of this section in the following manner:
     Removing the proposed concept of physicians and other 
practitioners being privileged to practice without appointment to the 
medical staff;
     Removing the proposed regulatory language that the 
granting of privileges is done in accordance with ``hospital policies 
and procedures;''
     Aligning the new regulatory language at Sec.  482.22 (a) 
with that currently found in the Governing body CoP (Sec.  
482.12(a)(1)) regarding the governing body requirement to determine, in 
accordance with State law, the categories of practitioners who are 
eligible for medical staff appointment;
     Revising existing Sec.  482.22(a)(2) to require the 
medical staff to examine the credentials of all eligible candidates and 
make recommendations for medical staff membership to the governing body 
in accordance with State law, including scope of practice laws, and 
with medical staff bylaws, rules, and regulations; and
     Revising existing Sec.  482.22(a)(2) to require that a 
candidate recommended by the medical staff and appointed by the 
governing body be subject to all medical staff bylaws, rules, and 
regulations in addition to the requirements in this section.
    We believe that these changes would not only satisfy the 
recommendations of the IOM report, but would also directly address the 
issues raised by commenters who opposed our proposed revisions. The 
regulatory language that we are finalizing here emphasizes the 
collaborative nature that must exist between the medical staff and the 
governing body of a hospital. It is a system of checks and balances 
between the governing body and the medical staff (and, to a certain 
degree, also between an individual practitioner and the hospital's 
medical staff and governing body). Each has its own areas of authority. 
The medical staff has oversight of all practitioners practicing as part 
of the medical staff through processes such as peer review and re-
privileging. The governing body has the authority to establish the 
categories of practitioners (regardless of the terms used to describe 
those categories) who are eligible for privileges and medical staff 
appointment, but must rely on the medical staff to apply the criteria 
for privileging and appointment to those eligible candidates and to 
make their recommendations before the governing body makes a final 
decision to appoint or not appoint a practitioner to the medical staff. 
With the changes contained in this final rule, we are ensuring that 
these areas of authority remain intact.
    The changes also leave room for a hospital or a governing body, 
after considering the recommendations of its medical staff, to appoint 
non-physician practitioners to the medical staff and to grant them 
privileges that are in alignment with their professional education and 
training to the full extent allowed under State licensing and scope-of-
practice laws. We encourage medical staff and hospitals to take 
advantage of the expertise and skills of these non-physician 
practitioners when making recommendations and appointments to the 
medical staff. We agree with commenters that an appointment to the 
medical staff engenders a sense of mutual responsibility for the 
activities and work of the medical staff for physicians; however, we 
believe that these sentiments are also engaged when non-physician 
practitioners are appointed members of a hospital's medical staff. We 
encourage physicians and hospitals to enlist qualified non-physician 
practitioners to fully assist them in taking on the work of overseeing 
and protecting the health and safety of patients. This applies not only 
to the ``work'' of the medical staff--such as quality innovation and 
improvement, best practices application, and establishment of 
professional standards--but also to the everyday duties of caring for 
patients. As many of the commenters expressed, we also believe that an 
interdisciplinary team

[[Page 29048]]

approach to patient care is the best model for patients. However, we 
also agree that physicians, owing to their training and expertise, must 
be the leaders in overall care delivery for hospital patients. The 
changes that we are making to the requirements clarify and affirm these 
precepts. However, this should not be construed to limit the authority 
of a physician to delegate tasks to other qualified healthcare 
personnel or to limit the authority of a non-physician practitioner to 
be responsible for the care of an individual patient, or patients, as 
allowed in accordance with State laws, medical staff bylaws, and 
hospital policies.
    Comment: A significant number of comments were supportive of the 
proposed changes to the Medical staff CoP at Sec.  482.22(b) that would 
expand the list of physicians who would be eligible to assume direct 
leadership responsibilities for the organization and accountability of 
the medical staff to include doctors of podiatric medicine (DPMs), when 
permitted by the State law of the State in which the hospital is 
located. This proposal would permit a DPM to fill this role, in 
addition to the categories of physicians that are allowed to assume 
this leadership position under the current requirements: an individual 
doctor of medicine or osteopathy or, when permitted by the State law of 
the State in which the hospital is located, a doctor of dental surgery 
or dental medicine. Many of these commenters cited the similarities in 
education, training, and experience that DPMs share with their 
allopathic and osteopathic colleagues as reasons for their support of 
this proposed change to the medical staff leadership requirements.
    One commenter expressed support for the proposal to include DPMs as 
eligible leaders of the medical staff and recommended that CMS extend 
this provision to other non-physician practitioners. However, the 
commenter pointed out that the non-physician practitioners eligible to 
fill the medical staff leadership role in a hospital should be limited 
to APRNs. The commenter recommended that PAs should be excluded from 
eligibility for the medical staff leadership role in hospitals because 
they believe that PAs lack the level of education, training, and 
experience that APRNs possess.
    There were also a significant number of commenters who opposed this 
proposed change. These commenters expressed concern over the precedent 
that this sets and maintained that practitioners who are not medical 
doctors or doctors of osteopathy should not be authorized to hold 
leadership positions on the medical staff of a hospital. The commenters 
also believe that in many hospitals, ``a `Chief Medical Officer,' 
someone hired by the hospital who is not a physician, is appointed to 
serve in a leadership position that would otherwise be held by a member 
of the medical staff.'' They stated that they believe our proposal to 
include DPMs could result in more of this type of activity and asked 
that we carefully consider the intended results of our proposed change 
to this provision.
    Response: We appreciate the comments that supported the proposed 
change. We also thank the commenters who expressed an opinion that was 
in opposition to our proposed revisions to this provision of the 
Medical Staff CoP.
    However, we do not see a connection between our proposal to include 
DPMs as potential candidates for medical staff leadership in any 
hospital where they are members of the medical staff and the alleged 
practice to which the commenters referred. Nor do we believe that the 
commenters opposing this proposal have provided any evidence that would 
lead us to believe that DPMs are not qualified to lead the medical 
staff of a hospital and that to do so would place the health and safety 
of patients at risk. Section 1861(r) of the Act includes DPMs under the 
definition of physician and nothing in the statute precludes a DPM from 
leading a medical staff if the medical staff selects one for this 
position and the governing body approves of the medical staff's 
selection. As we stated in the preamble of the proposed rule, we 
believe that DPMs possess the education, training, and experience that 
makes them qualified to hold such a leadership position if the hospital 
and its medical staff chooses to exercise this option. In addition, 
while we recognize the education, training, and experience that non-
physician practitioners bring to the care of hospital patients, we 
disagree with the commenter who recommended that APRNs be included in 
the list of eligible medical staff leaders, since this category of 
practitioner does not meet the statutory definition of physician. 
However, as we have noted above, we continue to encourage and support 
the inclusion of APRNs, PAs, and other non-physician practitioners on 
hospital medical staffs, as we believe they can assist physicians with 
the oversight and improvement of patient care. Therefore, we are 
finalizing this requirement as proposed.
4. Nursing Services (Sec.  482.23)
    We proposed 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 proposed that for those 
hospitals that use an interdisciplinary plan of care in providing 
patient care, the care plan for nursing services may be developed and 
kept current as part of the hospital's overall interdisciplinary care 
plan.
    We proposed 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 also 
proposed further revision to Sec.  482.23(c) to 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 
proposed to allow for these two revisions only if such practitioners 
were acting in accordance with State law, including scope-of-practice 
laws, and only if the hospital had granted them privileges to do so.
    Within this section of the Nursing services CoP, we also proposed 
changes that would allow hospitals to use standing orders. At Sec.  
482.23(c)(1)(ii), we proposed 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.
    We also proposed 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.
    At Sec.  482.23(c)(4) we proposed that those who administer blood 
transfusions and intravenous medications do so in accordance with State 
law and approved medical staff policies and procedures. We proposed to 
retain Sec.  482.23(c)(4) and redesignate it at Sec.  482.23(c)(5), 
without any content change.
    We also proposed additional revisions at 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 self-administer specific medications (non-controlled drugs and 
biologicals). We proposed requirements that a hospital would have to 
meet if it chooses to implement such a policy.

[[Page 29049]]

Nursing Services 482.23(b)(4)--Use of an Interdisciplinary Plan of Care
    Comment: A majority of commenters supported the revisions to this 
provision that would allow for the incorporation of the nursing care 
plan into the larger interdisciplinary care plan. A few commenters 
asked that we clarify what would be required regarding documentation of 
the interdisciplinary plan.
    Several commenters recommended that CMS add a requirement that all 
hospitals implement a hospital-wide staffing plan that would establish 
an appropriate number of registered nurses on each unit to meet the 
needs of the patients and the expectations of those units. They stated 
that the plan should take into account factors present on each unit 
during each shift, such as: the number of patients and the level and 
variability of intensity of care; the level of education, training, and 
experience of RNs providing direct patient care; and non-patient care-
related duties that nurses oversee.
    Response: We appreciate the comments supporting the rule as well as 
the suggestions for additional staffing requirements. The required 
documentation for the interdisciplinary care plan should follow the 
current documentation policies that hospitals are using to document the 
services provided by other disciplines to patients, such as services 
provided by physical therapists, occupational therapists, speech-
language pathologists, and others. Documentation should follow the 
standards of practice for those disciplines in addition to any specific 
requirements that a hospital might want to establish. The documentation 
must also comply with the requirements of the CoP at Sec.  482.24, 
Medical records services.
    Regarding the recommendations for additional staffing requirements, 
the regulation already requires the hospital to have adequate numbers 
of nurses to provide nursing care as needed, and makes it the 
responsibility of the director of nursing services to determine the 
types and number of nursing personnel and staff necessary to provide 
nursing care for all areas of the hospital. Therefore, we do not see 
the need to require any additional or more prescriptive regulations to 
address the nursing issues expressed by the commenters.
    Comment: One commenter stated that the Nursing Care Plan should not 
be merged with the service notes and treatment plans of other 
professionals for reasons of patient safety, transparency, authority 
and accountability to professional practice standards. The commenter 
believes that entries made by an RN should not be replaced with entries 
made by other disciplines. Another commenter stated that the 
interdisciplinary care plan should be the responsibility of nurses, who 
are better trained and positioned to ensure that the plan is patient-
centered and well-coordinated between disciplines. Another commenter 
recommended that we change 482.23(b)(4) to ensure that the nursing 
staff provides evidence in the medical record that the unique and 
changing needs of the patient are considered and met. They stated that 
this medical record documentation can be part of a nursing care plan, 
an interdisciplinary care plan, or a clinical pathway, or through other 
methods approved by the hospital.
    Response: While we understand to a certain degree the concerns 
expressed regarding the care plan, we do not understand the one 
commenter's concern that nursing entries would be replaced by entries 
made by other disciplines. The provision does not require a hospital to 
replace its nursing care plan with an interdisciplinary care plan nor 
does it require (or even permit) nursing entries to be replaced by 
entries made by another discipline. We proposed that the nursing care 
plan be permitted to be part of an interdisciplinary care plan based on 
hospital policy. The hospital is responsible for ensuring that the 
nursing staff develops and keeps current a nursing care plan for each 
patient and the hospital can determine if the nursing care plan is a 
part of a larger, coordinated interdisciplinary care plan. As proposed, 
the requirement was an option intended to provide flexibility for 
hospitals that believed patient care plans should reflect coordination 
of care by the various disciplines providing services to patients.
    Additionally, we disagree with changing the regulation by adding 
language that requires nurses to provide evidence in the medical 
records regarding how the needs of patients are met. In addition to the 
current requirement that an RN must supervise the nursing staff and 
evaluate the nursing care for each patient, the hospital must ensure 
that the nursing staff develops, and keeps current, a nursing care plan 
for each patient even if it is part of a larger, coordinated 
interdisciplinary care plan. We believe that the current requirements 
adequately ensure that the unique needs of each patient are addressed.
    Comment: A few commenters recommended that we require hospitals to 
conduct, no less than annually, an evaluation of the staffing plans 
based upon an assessment of patient outcome data that is nursing 
sensitive and that hospital staffing plans be made available to the 
public. The commenters also recommended that a perioperative RN should 
be present in each operating room acting as a circulator throughout the 
duration of each surgical procedure.
    Response: We agree with the commenters that hospitals should 
evaluate their nurse staffing plans and ensure that the appropriate 
staff is available to provide quality health care to all patients. We 
believe that it is implicit in the requirement for the director of 
nursing to determine the types and numbers of nursing personnel 
necessary that the director of nursing would periodically re-evaluate 
staffing plans to ensure that the nursing care needs of patients are 
met.
    Comment: One commenter recommended that the interdisciplinary team 
should include the patient/patient advocate/power of attorney in 
addition to the traditional healthcare team of providers to participate 
in the plan of care.
    Response: The regulations at 42 CFR 482.13 establish the right of 
the patient, or the patient's representative, as applicable, to 
participate in the development and implementation of his or her plan of 
care and to be informed of the patient's healthcare status and to make 
informed decisions about his or her care. We believe it would be 
redundant to also include these rights in the regulatory text related 
to the nursing or interdisciplinary plan of care.
Nursing Services 482.23(c)(1)(i)--Drugs and Biologicals May Be Prepared 
and Administered on the Orders of Other Practitioners (in Accordance 
With State Law and Scope of Practice Laws)
Nursing Services 482.23(c)(1)(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
Nursing Services 482.23(c)(3)(iii)--Orders for Drugs and Biological May 
Be Documented and Signed by Other Practitioners
    Comment: A significant number of commenters supported the proposed 
changes that would allow drugs and biologicals to be prepared and 
administered on the orders of other practitioners not specified under 
Sec.  482.12(c) if the practitioners are acting in accordance with 
State law, including scope-of-practice laws, and if the

[[Page 29050]]

hospital has granted them the privileges to write orders.
    Commenters were also very supportive of the inclusion and allowance 
for standing orders in the proposed revisions to the Nursing services 
requirements. We also received comments specifically supporting the use 
of standing orders to encourage immunizations, notwithstanding the 
regulations at Sec.  482.23(c)(3), which allow for nurse-initiated 
administration of influenza and pneumococcal polysaccharide vaccines 
per physician-approved hospital policy after an assessment of 
contraindications. Commenters were enthusiastic about the positive 
effect that they believed the use of standing orders would have for the 
broader patient population in general and for hospital infection 
control efforts specifically in terms of a possible increase in the 
immunization rate.
    Similarly, there was extensive support for the proposed revisions 
to allow for ``other practitioners not specified under Sec.  
482.12(c)'' to document and sign orders for drugs and biologicals, 
provided that such practitioners meet the provisions discussed above. 
Many commenters stated that they believe the changes will allow other 
qualified practitioners the flexibility to address the immediate needs 
of patients without delay and that it will increase efficiency and the 
quality of patient care at the same time. One commenter stated that the 
changes will ``lessen the impact of the current shortage of general 
practitioner MDs, thereby allowing patients fuller access to care'' by 
allowing other qualified practitioners the ``ability to write orders 
and to practice to the full extent of their scope of practice and State 
law.''
    Response: We thank the commenters for their support of the proposed 
revisions to these provisions in the Nursing services CoP. We agree 
that the changes will help to eliminate unnecessary delays in 
treatment, improve access to care for hospital patients, and improve 
immunization rates for the broader patient population. We appreciate 
the support from commenters on the proposed standing orders provisions 
contained in this section and will discuss the comments on these 
changes in the Medical record services section that follows this 
section. However, we should point out that the changes finalized here 
and in the Medical record services section regarding the use of orders 
(including pre-printed and electronic standing orders, orders sets, and 
protocols) do not allow for the use of nurse-initiated orders (beyond, 
or in addition to, those currently allowed for influenza and 
pneumococcal vaccination) without an authenticated physician or 
practitioner order. We should also note that while the provisions 
finalized here will allow for a qualified non-physician practitioner to 
write orders and to practice to the full extent of his or her State 
scope of practice, some insurers, including Medicare, may only pay for 
the services ordered by a physician or for the services ordered 
incident to a physician's services.
    Comment: Several commenters took exception to the fact that the 
proposed language in these provisions does not defer to medical staff 
bylaws, rules, and regulations. Other commenters also expressed serious 
concerns about what they categorized as ``the proposal to expand the 
types of practitioners who are able to administer drugs and biologics, 
particularly as [such proposal] relates to anesthesia and pain 
management.'' The commenters believe that expanding the number of non-
physician providers able to administer certain drugs, such as opioids, 
would only exacerbate the problem of prescription drug overdoses. They 
urge CMS to withdraw the proposal on the grounds that ``non-physician 
providers may not have sufficient education or training in the proper 
prescribing of opioids, including patient selection and risk 
assessment.''
    Response: We thank the commenters for noting our failure to 
properly defer to medical staff bylaws, rules, and regulations with 
regard to this issue and we agree that, in addition to our deference to 
State laws and hospital policies, the provisions must also defer to the 
bylaws, rules, and regulations of the hospital's medical staff. 
Therefore, we are revising the proposed requirements to include this 
reference in this final rule.
    Regarding the comments that expressed concern over non-physician 
providers ``administering'' certain medications related to anesthesia 
and pain management, such as opioids, we believe that the commenters 
may have been confused over the language of the proposed requirements. 
We point out that the requirements that we are finalizing in this rule 
are with regard to allowing drugs and biologicals to 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 medical staff 
bylaws, rules, and regulations. However, the commenters also mentioned 
the prescribing of opioids by practitioners other than physicians and 
believe that these practitioners may lack the education and training to 
adequately and safely prescribe (or order) these types of drugs for 
patients. We respectfully disagree and maintain that if these 
practitioners, in ordering drugs and biologicals, are acting in 
accordance with the State laws (including scope-of-practice laws) of 
the State in which the hospital is located, and if the hospital, 
through its policies, and the medical staff, through its bylaws, rules, 
and regulations, authorize them to do so, then they have been 
determined competent to order these medications.
Nursing Services 482.23(c)(3)--Administration of Blood Transfusion and 
Intravenous Medications (in Accordance With State Law and Approved 
Policies and Procedures) by Trained Non-Physician Practitioners
    Comment: Many commenters agreed with the deletion of the 
requirement that non-physicians have special training in administering 
blood transfusions and IV medications. However, several commenters 
stated that, given the immediate and significant risk to a patient if 
these procedures are done incorrectly, the only personnel permitted to 
do them should be an RN, APRN, PA, or physician. They also argued that 
this personnel requirement should be added to the regulatory language. 
Another commenter stated that we should clarify in the final rule that 
this revision includes all categories of APRNs (CRNAs, CNMs, CNSs, and 
NPs) who are acting in accordance with State law and hospital policy.
    Response: We appreciate all of the comments supporting the proposed 
change. However, we want to clarify that only the non-physician 
personnel who have received training in administering blood 
transfusions and intravenous medications, in accordance with State law 
and approved medical staff policies and procedures, will be allowed to 
provide these services. We disagree with the suggestion that we specify 
the exact practitioner-types who are qualified to provide these 
services because we believe that these defined criteria will prevent 
unqualified personnel from administering blood transfusions and IV 
medications.
    Comment: A few commenters opposed our eliminating the requirement 
that non-physicians have special training in administering blood 
transfusions. One commenter stated that while nurses may receive 
training in administering intravenous medication in nursing school, the 
training is often not comprehensive. Generic training on IV drug 
administration may not give individuals the appropriate awareness

[[Page 29051]]

of difficulties with administering special medications intravenously. 
Since intravenous drugs typically pose greater risks than orally 
administered drugs and they are typically used in patients who are ill, 
this change could have an adverse effect on patient safety. One 
commenter recommended that CMS allow registered nurses to explain and 
receive informed consent for blood transfusions. They stated that most 
facilities already use RNs to discuss the risks and benefits of blood 
transfusion with a patient. They also recommended that RNs be allowed 
to document a patient's informed consent without requiring the services 
of a physician because the current practice is cumbersome and causes 
undue delay in treatment.
    Response: We respectfully disagree with the commenters. We proposed 
that blood transfusions and intravenous medications be administered in 
accordance with State law and approved medical staff policies and 
procedures. The majority of commenters stated that this training is 
standard practice and does not need to be prescribed in these 
regulations. Regarding the recommendation that CMS allow registered 
nurses to explain and obtain informed consent for a blood transfusions, 
the current requirements do not preclude nurses from performing this 
task. Informed consent is discussed in three locations in the CMS 
hospital CoPs: Sec.  482.13(b)(2) pertaining to patients' rights; Sec.  
482.24(c)(2)(v), pertaining to medical records services; and Sec.  
482.51(b)(2), pertaining to surgical services. The corresponding 
guidelines to these three provisions contain extensive discussions 
regarding what constitutes a properly executed informed consent form, 
as well as information on what additional information might also be 
contained in a well-designed informed consent form. Hospitals must 
establish their own policies regarding informed consent, including 
which procedures require informed consent and who may obtain the 
informed consent.
Nursing Services 482.23(c)(6)--Patient Self-Administration of Both 
Hospital-Issued Medications and the Patient's Own Medications Brought 
Into the Hospital
    Comment: The majority of comments received were in support of this 
revision that would allow a patient (or his or her caregiver/support 
person where appropriate) to self-administer both hospital-issued 
medications and his or her own medications brought into the hospital. 
However, many commenters advised that patient self-administration would 
only be successful if the hospital had a process in place to evaluate 
each patient to determine if self-administration was appropriate for 
that particular patient. One commenter stated that ``used properly and 
with the right patients, self-administration can be an extraordinarily 
helpful tool for teaching self-care as a patient and his or her family 
begin the transition back home,'' and further emphasized allowing for 
some flexibility in the implementation of this process so that nurses, 
physicians, and other practitioners would be fully able to exercise 
their clinical judgment when deciding which patients were appropriate 
for self-administration of medications. Many commenters believed that 
this type of medication regimen reinforcement prior to discharge could 
help to reduce and prevent costly patient readmissions secondary to 
medication errors and non-compliance.
    A number of commenters expressed their belief that patient self-
administration of medications would actively engage the patient in his 
or her plan of care and could serve to keep the patient more fully 
involved in the treatment process, which could in turn reduce the 
length of stay for the patient and subsequently prevent the patient's 
readmission.
    Response: We thank the commenters for their support of these 
revisions. We agree with the commenters who stated that a hospital 
program for patient self-administration of medications could be 
extremely beneficial for the appropriate patients if the proper 
precautions were taken in designing and implementing such a program. 
With regard to the comments that pointed out that teaching patient 
adherence to the proper medication regimen prior to discharge could 
have a positive impact on reducing hospital patient lengths of stay and 
readmission, we also agree, and encourage hospitals considering 
adoption of a medication self-administration policy to look to the 
medical literature for examples of best practices and their use in 
successful patient self-medication programs.
    Comment: Several commenters opposed the proposal allowing for 
patient self-administration of medications. Some of these commenters 
expressed serious concerns about the proposal and focused on those 
aspects of the revisions related to the nursing education of patients 
and the subsequent nursing oversight of patients self-administering 
medications as well as the nursing documentation of patient self-
administration. The commenters were concerned that these aspects of the 
policy would place undue burden on a nurse's already limited time for 
patient care. Commenters questioned how nurses would document patient 
self-administration in the patient's medical record if they did not 
administer or witness the administration of the medication.
    A few commenters stated that they opposed the proposed revisions 
because of their concerns about medication safety, including the proper 
storage and security of medications, especially controlled substances; 
the time needed for hospital pharmacists to identify and label 
medications brought from home; control over which medications (and the 
dosages) the patient is taking; maintenance of needed supply of 
medications brought from home and procedures in event of shortage; 
administration of medications not approved for use in hospital; and 
quality and integrity of medications brought from home, including 
issues with expired medications brought from home. One commenter stated 
that we should clarify that a patient should not be allowed to bring 
their own drugs, except in rare and unavoidable circumstances. Other 
commenters stated that the proposed requirements were na[iuml]ve and 
that they were clearly not developed by clinical professionals. These 
commenters also believe that these requirements would endanger the 
safety of the most vulnerable hospital populations: the elderly and the 
chronically ill. They pointed out that medication errors and compliance 
with medication regimens are often the cause for hospital admissions 
and readmissions.
    Response: We appreciate the concerns that commenters have expressed 
and we have made some revisions to certain areas of the proposed 
requirements that we believe will address some of these concerns. 
Specifically, we have revised Sec.  482.23(c)(6)(i)(D), Sec.  
482.23(c)(6)(i)(E), Sec.  482.23(c)(6)(ii)(D), and Sec.  
482.23(c)(6)(ii)(E) in this final rule by now requiring the hospital to 
have policies and procedures in place to address the security of the 
medication(s) for each patient and to document the administration of 
each medication, as reported by the patient (or the patient's 
caregiver/support person where appropriate), in the patient's medical 
record for both hospital-issued medications and those brought from 
home. We believe that these changes will clarify the questions that we 
received through the comments regarding the security of specific 
medications as well as the procedures for documenting the self-
administration

[[Page 29052]]

of medications when a nurse does not witness it.
    We believe that the security of a patient's self-administered 
medications is extremely important, but it is an issue that does not 
lend itself well to a one-size-fits-all requirement similar to the one 
we originally proposed that would require a hospital to have policies 
and procedures in place to ensure the security of the medication(s) of 
each patient. We are aware that there are Federal and State laws, 
including the current Pharmaceutical services CoP at Sec.  482.25, that 
require a higher level of security for certain medications (for 
example, controlled substances). We expect hospitals to comply with 
these already-established requirements and laws and we do not expect 
hospitals to include these medications and other similar medications 
and drugs as part of a patient self-administration program. Indeed, a 
hospital may find that there are other medications that it believes 
should be excluded from patient self-administration due to concerns 
over its own capacity to address the security of these medications for 
patients. A hospital may choose to have a policy where it maintains a 
list of medications that it excludes from self-administration entirely; 
to have a policy that addresses the security of a particular medication 
on a patient-by-patient basis; or to establish a policy that is a 
combination of both these approaches to medication security.
    Hospitals are also free to establish different levels of patient 
self-administration (e.g., with or without a nurse present to supervise 
the self-administration) that could be determined either by the 
practitioner issuing the order to permit self-administration of 
specific medications or by the nurse after he or she conducts the 
assessment of the patient (or caregiver/support person) to determine 
his or her capacity for self-administration of the specific medications 
ordered. We would expect a nurse to exercise his or her clinical 
judgment and to inform the practitioner responsible for the care of the 
patient about any reservations the nurse might have regarding an 
individual patient's (or caregiver's/support person's) capacity to 
safely self-administer medications. We would also expect that a nurse 
would document the assessment of a patient's capacity to self-
administer medications, highlighting the affirmative or negative 
findings along with any discussions that the nurse might have with the 
practitioner responsible for the care of the patient regarding the 
patient's capacity to self-administer.
    Regarding documentation of self-administered medications, we 
believe our original proposed requirement for documentation was too 
rigid and introduced the possibility that a nurse would have to 
document un-witnessed patient self-administration of a medication in 
the same manner he/she would if he/she had witnessed it or had 
administered the medication to a patient himself/herself. That is why 
we are finalizing our revisions to the proposed requirements in this 
rule that will allow for a nurse to document the administration of the 
medication as reported by the patient (or the patient's caregiver/
support person where appropriate). We believe that this represents a 
more realistic approach to documentation that does not require a nurse 
to document an action by the patient that she did not witness. Instead, 
the nurse now will have the option in these cases of documenting the 
patient's attestation of the medication self-administration.
    Regarding the commenters' other concerns (which were largely 
focused on self-administration of medications brought from home), we 
note that this requirement will be an optional method for the 
administration of medications and that hospitals will still have the 
flexibility to prohibit patient self-administration of medications in 
any form. A hospital must determine for itself, through its medical 
staff and its nursing and pharmacy leadership, and in consultation with 
legal counsel and risk management, whether it believes that it can 
establish a medication self-administration program that will be safe as 
well as beneficial for patients. Studies indicate that a well-designed 
and implemented medication self-administration program can be both safe 
and beneficial for patients. In addition to presenting their own 2006 
study in the Journal of Clinical Nursing (Grantham G, McMillan V, Dunn 
SV, Gassner L-A, Woodcock P (2006) Patient self-medication--a change in 
hospital practice. J Clin Nurs Aug;15(8): 962-970) Grantham et al. 
reviewed the literature for previous studies of hospital patient self-
administration programs. These studies generally found that effective 
self-administration programs are associated with high levels of patient 
satisfaction as well as with increases in patients' knowledge, self-
esteem, and independence. The authors also noted in their review of the 
literature that there is ``some evidence to suggest that patients who 
self-administer medications in hospital have fewer medication errors 
and medication-related problems postdischarge.'' Regarding the results 
of their own study, Grantham et al concluded that their program 
``achieved high levels of nursing and patient satisfaction, contributed 
to efficient patient discharge and was safe.''
    Should a hospital choose to establish such a program, we would 
expect it to comply with all of the requirements finalized here as well 
as with other existing laws and regulations pertaining to medications 
and their administration to patients.
Additional Comments Received Beyond the Scope of This Rulemaking
    Comment: A commenter suggested that CMS should extend Part B 
coverage to all vaccines recommended by the CDC's Advisory Committee on 
Immunization Practices.
    Response: We appreciate this comment, however no such changes will 
be made to this provision. This comment is outside the scope of this 
section and outside of the proposed rule.
5. Medical Record Services (Sec.  482.24)
    The current requirements, at Sec.  482.24(c)(1)(i), specify that 
all orders, including verbal orders, must be dated, timed, and 
authenticated promptly by the ordering practitioner. Current 
regulations also include 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 Sec.  
482.12(c) and who is authorized to write orders by hospital policy in 
accordance with State law. This requirement has now expired and is no 
longer in effect. 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.
    We proposed 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

[[Page 29053]]

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.'' We also proposed to 
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. We noted that 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.
    We proposed changes to the Medical records services CoP that would 
allow hospitals to use standing orders as long as certain provisions 
were met. We proposed 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) 
Established that such orders and protocols had been reviewed and 
approved by the medical staff in consultation with the hospital's 
nursing and pharmacy leadership; (2) demonstrated that such orders and 
protocols are consistent with nationally recognized and evidence-based 
guidelines; (3) ensured that the periodic and regular review of such 
orders and protocols was 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) ensured that such orders and protocols were 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.
    Comment: Concerning proposed Sec.  482.24(c)(3)(i) and (iii), some 
commenters recommended removing the language, ``in consultation with 
the hospital's'' after ``staff'' so that the sections would read, 
``medical staff, the hospital's nursing and pharmacy leadership.'' 
Nursing and pharmacy leadership would then be full partners in both 
approving pre-printed and electronic standing orders, order sets, and 
protocols for patient orders and ensuring there is a periodic and 
regular review of these orders. One commenter pointed out that these 
types of orders are often multi-disciplinary and comprehensive and 
patients would benefit from a more broad-based development and 
implementation of these orders and protocols.
    Response: We agree that the nursing and pharmacy leadership of a 
hospital should be full partners in approving pre-printed and 
electronic standing orders, order sets, and protocols and in ensuring 
that these orders are periodically reviewed to determine the continuing 
usefulness and safety of the orders and protocols. Therefore, in this 
final rule, we have removed the language, ``in consultation with'' and 
added, ``and,'' after ``medical staff.'' Thus, the language in both 
Sec. Sec.  482.24(c)(3)(i) and (iii) reads, ``medical staff, and the 
hospital's nursing and pharmacy leadership.''
    Comment: We received some comments that requested further guidance 
or clarification concerning the proposed changes in this section. One 
commenter noted that the proposed requirements related to verbal orders 
and standing orders did not address residents. The commenter requested 
that CMS use IGs to thoroughly consider issues related to residents and 
ensure that the requirements do not become an impediment to the 
residents' education. The commenter also requested that the 
interpretative guidelines address certain specific issues.
    Response: CMS will develop IG documents after the publication of 
this final rule to assist hospitals, surveyor, and the public in 
implementing this final rule. In developing that guidance, we will 
consider the commenters' recommendations.
    Comment: We received one comment requesting that we remove the 
word, ``promptly,'' in Sec.  482.24(c)(2) and replace it solely by 
reference to timeframes established by hospital policy.
    Response: We do not agree with the commenter. With the removal of 
the 48-hour requirement for the authentication of orders from the 
hospital CoPs, the timeframe for authenticating orders would be 
determined by hospital policy in accordance with State law. However, we 
believe that quality patient care requires that authentication of 
orders should be done in a timely manner. Hence, we have left the word 
``promptly'' in this provision.
Authentication of Orders by ``Other Practitioners''
    Comment: We received numerous comments on our proposal at Sec.  
482.24(c)(2) that would allow other practitioners who were responsible 
for the care of a patient as specified in Sec.  482.12(c) and 
authorized to write orders by hospital policy in accordance with State 
law to authenticate an ordering practitioner's orders, including verbal 
orders, beyond the sunset date of the current regulation. Some of the 
commenters noted that the requirement to have the ordering physician 
authenticate the order was overly burdensome to hospitals, doctors, and 
the nursing staff and did not result in any benefit for patient safety. 
They indicated that this change would give hospitals more flexibility 
so that they could focus on efficient, safe, high quality and patient-
centered care. Some commenters noted that it was particularly important 
in certain cases, such as situations where there are residents who 
rotate between multiple institutions, restrictions on duty hours, and 
in situations where practitioners practice in rural areas.
    Response: We thank the commenters for their support for the 
proposed changes to this section.
    Comment: We received one comment that expressed concerns over the 
qualifications of the practitioners who would have authority to 
authenticate orders. A national organization of pediatricians stated 
that, in the case of pediatric patients, only a practitioner 
credentialed in pediatric care should authenticate orders.
    Response: We understand the commenter's concerns. However, 
authentication of an ordering practitioner's orders must be ``by 
hospital policy and in accordance with State law.'' Hospitals may chose 
to restrict which practitioners it would authorize to authenticate 
another practitioner's orders. For example, as with the commenter's 
example, a hospital could choose to restrict authentication of orders 
for pediatric patients to practitioners who are privileged to provide 
pediatric care. We are confident that hospitals will address these 
issues in their policies.
    Comment: We received several comments, including comments from 
advanced practice registered nurses (APRNs), national associations for 
both registered nurses and APRNs, and a medical center that suggested 
that limiting the practitioners who could authenticate an ordering 
practitioner's order to practitioners listed in Sec.  482.12(c) would 
exclude APRNs and other non-physician practitioners. Some of these 
commenters noted that health care is increasingly provided by 
interdisciplinary teams and that the previous limitation created an 
undue burden. Some commenters stated that since APRNs and other 
practitioners were allowed to order drugs and biologicals if they had 
been granted hospital privileges to do so and they

[[Page 29054]]

were acting in accordance with State laws, including scope-of-practice 
laws, then those practitioners should be allowed to authenticate 
orders. The commenters recommended either deleting the reference to 
Sec.  482.12(c), adding APRNs and other advanced practitioners to the 
list in Sec.  482.12(c), or explicitly stating the APRNs could 
authenticate orders for other practitioners.
    Response: We agree with the commenters that APRNs and other non-
physician practitioners should have the authority to authenticate 
orders. Regarding the reference to Sec.  482.12(c), we must note that 
this paragraph applies only to Medicare patients and is based on the 
statutory language at subsections 1861(e) and (r) of the Social 
Security Act. Even with regard to Medicare patients, the language at 
Sec.  482.12(c) does not entirely exclude APRNs and other non-physician 
practitioners from authenticating orders. Section 482.12(c)(1)(i) 
states that, ``This provision is not to be construed to limit the 
authority of a doctor of medicine or osteopathy to delegate tasks to 
other qualified health care personnel to the extent recognized under 
State law or a State's regulatory mechanism.'' If State law and a 
hospital's policy allow PAs and APRNs to authenticate orders, a 
physician could delegate that authority to them with regard to Medicare 
patients.
    However, in analyzing these comments and in preparing our responses 
to them, we came to the conclusion that this reference to Sec.  
482.12(c) was inappropriately inserted into this section of the CoPs, 
most likely when revisions to this section were finalized in the 
November 27, 2006 rule (71 FR 68694). Since Sec.  482.12(c) is still 
statutorily required with regard to practitioners and the 
responsibilities for the admission and care of Medicare patients, we 
have not made any changes to Sec.  482.12(c) as the commenters 
recommended. However, we do believe that the removal of the reference 
to Sec.  482.12(c) is warranted in that the requirements discussed here 
apply to all patients and not Medicare patients exclusively. Therefore, 
in this final rule, we are revising this provision to delete the 
reference to Sec.  482.12(c) and to require that all orders must be 
authenticated promptly by the ordering practitioner or by another 
practitioner who is responsible for the care of the patient only if 
such a practitioner is acting in accordance with State law, including 
scope-of-practice laws, hospital policies, and medical staff bylaws, 
rules, and regulations. We point out that we are taking the opportunity 
to also revise the language pertaining to State law, hospital policies, 
and medical staff bylaws, rules, and regulations in order to make it 
consistent with the changes we have made elsewhere in this rule that 
were based on comments received and which are consistent with industry 
practice.
    Comment: We received a comment from a medical society that 
supported the easing of the timeframe for authentication of verbal 
orders; however, the commenters had concerns with the proposal to allow 
authentication of verbal orders by other practitioners. They were 
concerned about how orders could be interpreted and how this could 
affect patient care. They recommended that CMS not finalize the 
proposal to permit the authentication of orders by other practitioners.
    Response: We disagree with the commenter. The commenter did not 
offer any evidence that having one practitioner authenticate the orders 
of another practitioner would have a negative impact on patient care. 
In fact, most of the commenters for this proposed change indicated that 
they thought it would not only reduce the burden to hospitals, 
practitioners, and nurses, but would also improve patient care.
    Comment: We received one comment from a hospital association that 
stated the changes proposed to verbal order authentication provision 
could result in the unintended shift of liability to the hospital and 
hospital personnel receiving verbal orders and away from the physician/
practitioner who bears ultimate responsibility for ensuring the medical 
necessity of the order. They stated that some States do not have 
specific timeframes for authentication. Some States defer to Federal 
regulations, and some State provisions contain ambiguous terms such as 
``in a manner consistent with good medical practice'' or ``before 
billed.''
    Response: Issues surrounding a hospital's tort liability concerning 
verbal orders authentication are State law matters and beyond the scope 
of this rule. Moreover, a hospital is free to adopt a more stringent 
policy than that required under the regulations, should it believe it 
is prudent to do so.
    Comment: We received one comment in which the commenter supported 
expanding the eligibility of qualified practitioners to authenticate 
verbal orders. However, they asked for clarification regarding the CMS 
definition of ``another practitioner who is responsible for the 
patient.'' They noted that the definition of ``responsible'' could have 
practice implications for multiple providers and could increase costs 
by adding unnecessary physician supervision.
    Response: CMS will develop IGs after the publication of this final 
rule to assist with the implementation of this final rule for 
providers, surveyors, and the public. We will consider the commenter's 
request in developing those guidelines. In addition, we believe that 
hospitals would address which practitioners would be deemed 
``responsible for the patient'' in their policies.
Elimination of the 48-Hour Requirement for Authenticating Orders
    Comment: We received several comments and most were supportive of 
the proposal to eliminate the requirement for an ordering practitioner 
to date, time, and authenticate orders within 48 hours.
    Response: We would like to thank the commenters for their support 
of our proposal. We have finalized this section as proposed.
    Comment: We received a few comments that expressed concern about 
possible errors. One commenter questioned who would catch any errors in 
orders if the ordering practitioner did not authenticate the order 
within 48 hours. Some commenters were concerned about whether the 
individual receiving the order would accurately interpret the order and 
the impact that could have on patient care. Another commenter stated 
the 48-hour requirement did nothing for patient safety and the issue 
really was whether the nursing staff immediately read back and verified 
the verbal order with the practitioner. One of these commenters 
recommended not finalizing the language that would permit other 
practitioners to authenticate orders.
    Response: We agree with the commenters that the possibility of 
errors associated with verbal orders is an important issue, and that is 
why we continue to believe that hospitals should make efforts to 
minimize the use of verbal orders. We also agree with the commenter 
that it is expected that the standard practice would be for the person 
taking the order to read the order back to the practitioner to ensure 
that they have correctly understood it. In addition, this final rule 
does not mandate that a hospital allow other practitioners to 
authenticate an ordering practitioner's orders. Other practitioners can 
only authenticate orders if, among other requirements, it is in 
accordance with hospital policy and State law. Therefore, we disagree 
with the commenter that recommends not finalizing this provision. Thus, 
we have

[[Page 29055]]

not made any changes to the language in proposed Sec.  482.24 to add 
any additional requirements for verbal orders.
    Comment: A hospital association questioned why CMS and physicians 
continue to support time periods for other types of physician 
documentation (for example, history and physicals, anesthesia 
evaluations, review of restraint orders) but do not support the 
timeframes for verbal orders. The commenter gave the following reasons 
why CMS should reconsider the proposed policy of removing a defined 
timeframe for authentication: (1) Accountability of the prescribing 
physician/practitioner for medical necessity; (2) to validate that 
hospital staff received, transcribed and performed orders 
appropriately; and (3) to document that the physician/practitioner 
reviewed the patient's medical record entries, findings and other 
related documents when making medical decisions.
    Response: We believe that the hospital CoPs should ensure that 
patients receive high quality care, while avoiding unreasonably 
burdensome requirements for hospitals. In the case of the requirement 
for an ordering practitioner to authenticate orders within 48 hours, 
the majority of commenters noted that the requirement was overly 
burdensome to hospitals, physicians, and nurses without providing any 
commensurate increase in patient safety/quality of care. In addition, 
we do not believe that having another practitioner authenticate an 
order for another practitioner would negatively affect a patient's 
care. The ordering practitioner, as well as the practitioner who 
authenticates the order, must be responsible for the patient's care. As 
other comments noted, interdisciplinary teams increasingly provide 
health care. All of the practitioners should be communicating and 
working together in their care of the patient. Therefore, we have 
finalized the removal of the requirement for authentication of orders 
by the ordering physician within 48 hours as proposed.
Standing Orders
    Comment: We received numerous comments that were supportive of 
expanding the use of pre-printed and electronic standing orders, order 
sets, and protocols. Commenters noted that the use of standing orders 
contributes to patient safety and quality of care by providing 
evidence-based medicine and standardization. They indicated that using 
these types of orders would allow for faster implementation of care for 
patients. There would be less waste and procedural burden. Physicians 
would be able to spend more of their time on directly providing care to 
patients. Standing orders also allow other providers to take on 
additional tasks and simplify administrative processes.
    Response: We thank the commenters for their support for the 
proposed change in this section. We have finalized this section as 
proposed.
    Comment: We received a few comments that requested the development 
of further guidance on standing orders. A few commenters specifically 
wanted further guidance, especially for pediatric patients, 
vaccinations, and emergency department patients. One commenter noted 
that our proposed revisions did not address how the presence of 
resident physicians would affect the use of standing orders and 
requested that CMS address the use of standing orders as related to 
residents in the IGs. One commenter requested very specific issues be 
addressed in the IGs. A few commenters also requested that we provide 
definitions for ``pre-printed, standing orders, order sets, and 
protocols.'' They stated that we need to clarify the meaning of these 
terms if they are not used synonymously.
    Response: Although we will develop further IGs after the 
publication of this final rule for hospitals, surveyors, and the public 
to implement this final rule, there is no basis in the regulations for 
our requiring hospitals to develop differential policies that 
specifically address pediatric or emergency department patients or 
particular types of drugs, with the exception of pneumonia and 
influenza vaccinations.
    We are unclear what assertion the commenter is attempting to convey 
when the commenter refers to ``how the presence of resident physicians 
would affect the use of standing orders.'' Since the commenter did not 
explain this statement further, we can only assume that he or she meant 
to state that the presence of residents in a hospital would somehow 
affect whether a hospital might or might not use standing orders. With 
regard to resident programs and resident practice in hospitals, the 
IGs, in two separate instances, already discuss various aspects of 
resident practice in hospitals, though neither discussion addresses the 
use of standing orders by residents. Even though the IGs do not 
specifically address the use of standing orders by residents, we 
believe that it is useful to note where the current IGs do address 
other aspects of resident practice because these guidelines might be 
applicable to the comment as best we can discern it.
    In the context of the requirements for patient restraint and 
seclusion orders (contained in the Patients' rights CoP at Sec.  
482.13(e)(5)), the use of standing orders by residents would be 
determined and authorized by a hospital's medical staff and residency 
program faculty as they see appropriate for the care of hospital 
patients and in accordance with any State laws governing the practice 
of residents in hospitals.
    Regarding the commenters' requests for definitions of the various 
terms that we use in the provisions pertaining to standing orders, we 
refer the commenters to the proposed rule (76 FR 65895), which contains 
an extensive discussion of pre-printed and electronic standing orders, 
order sets, and protocols within both the Nursing services section and 
the Medical records services section of the preamble. Within the 
proposed rule, we also cite CMS S&C-09-10, which provides additional 
guidance on the use of standing orders. Over the last several years, 
our research into the issue of standing orders, including our 
discussions with hospital stakeholders, has led us to conclude that 
there is no standard definition for standing orders in the hospital 
community at large. Therefore, we chose to establish the criteria by 
which a hospital may establish standing orders, whether those orders 
are conveyed in printed or electronic form, in orders sets, or as 
protocols. Since agreement on what is meant by the term, ``standing 
orders'' does not exist, hospitals must focus on their compliance with 
the requirements finalized here, as they establish policies and 
procedures to create and use these types of orders.
    Comment: We received a comment in which one commenter strongly 
disagreed with expanding the use of standing orders. The commenter 
believed that using standing orders would place the hospital staff in a 
position of having carried out orders from pre-printed orders, standing 
orders, order sets and protocols in good faith without an order from a 
physician, and that the absence of a physician order would potentially 
place the hospital and its staff in a legally compromising situation.
    Response: The legal liability a hospital or hospital personnel 
could experience from using standing orders is beyond the scope of this 
final rule. However, hospitals and other healthcare institutions for 
many years have used standing orders. In addition, standing orders and 
protocols must meet all of the requirements at Sec.  482.24(c)(3) of 
this final rule. Those requirements include authentication by either 
the ordering

[[Page 29056]]

practitioner or another practitioner responsible for the patient's care 
acting in accordance with State law, including scope-of-practice laws, 
hospital policies, and medical staff bylaws, rules, and regulations 
(Sec.  482.24(c)(3)(iv)). First and foremost, there must be an 
initiating order (by a practitioner authorized to give such an order) 
for specific pre-printed or electronic standing orders, order sets, or 
protocols to be used for a particular patient. As we stated in the 
preamble to the proposed rule (76 FR 65896), hospital standing order 
policies and procedures ``should address well-defined clinical 
scenarios for the use of such orders'' and that CMS would expect that 
these same policies and procedures would also address the process by 
which a standing order is ``initiated by authorized staff.'' Within 
this same section of the proposed rule, we also stated, ``under no 
circumstances should a hospital use standing orders [pre-printed or 
electronic standing orders, order sets, and protocols] 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.'' In addition, the final rule allows hospitals 
the use of standing orders; it does not mandate their use. Therefore, 
hospitals concerned about potential legal liability associated with 
standing orders are not obligated to permit their use. It should also 
be noted that while standing orders may be used as prescribed under the 
provisions finalized here, hospitals should be aware that some 
insurers, including Medicare, might not pay for the services provided 
because of these orders.
    Comment: We received a few comments that expressed concern about 
how the proposed language, ``authenticated promptly in the patient's 
medical record,'' could be interpreted. The commenters stated that they 
believed our intent was to ensure that the standing order or protocol 
appears in the patient's record. However, they stated that this 
language could be interpreted as requiring that each individual patient 
must have his or her own standing order for drugs and/or biologicals. 
They suggested that this interpretation would actually increase the 
burden on nurses.
    Response: We appreciate the commenters concern about how some 
individuals could interpret the language in Sec.  482.24(c)(3)(iv). The 
medical record is expected to include the standing order that was used 
for the patient, in order to fully and accurately document the care 
provided. In the case of an electronic health record or a pre-printed 
order set, it should not prove unduly burdensome to incorporate the 
standing order into the patient's record. Requiring a separate, 
subsequent authentication, which simply makes reference to the included 
order as the subject of authentication, also should not prove 
burdensome for practitioners. Both the current requirements and 
standards of practice regarding medical records dictate that any 
patient order given by a practitioner authorized to do so automatically 
becomes a required part of the patient's medical record and must be 
documented to reflect this, regardless of whether it is contained in 
pre-printed or electronic standing orders, order sets, or protocols, or 
whether it is a written or verbal order.
6. Infection Control (Sec.  482.42)
    We proposed to eliminate the current provision at Sec.  
482.42(a)(2), which requires the infection control officer or officers 
to maintain a log of incidents related to infections and communicable 
diseases. We proposed to replace this provision with the requirement 
that the infection control officer or officers develop a system for 
identifying, reporting, investigating, and controlling infections and 
communicable diseases of patients and personnel.
    Comment: Nearly all comments received stated that the present 
requirement for a separate infection control log is redundant and 
unnecessary, given advances in technology and surveillance systems. 
Many commenters also suggested that complying with the requirement for 
a separate infection control log merely diverts scarce resources from 
other efforts. Several comments noted that the proposed changes were 
both appropriate and timely. Several also expressed appreciation to CMS 
for the proposed change.
    Response: We thank commenters for their support of our proposal. We 
agree with the commenters and will finalize our proposed change to 
remove the log. We recognize that infection control surveillance 
systems have made substantial advances since the time when this CoP was 
first implemented. We agree with commenters that technological advances 
have made the need for a separate infection log obsolete. CMS believes 
the revised rule presents hospitals with an important opportunity to 
reduce operating costs and promote patient safety goals.
    Comment: One commenter specifically remarked that modern 
surveillance methodologies are targeted, in real time, and based on the 
epidemiology of the area being monitored. The commenter stressed that 
eliminating the requirement for a separate log will allow Infection 
Preventionists (IPs) and Hospital Epidemiologists (HEs) to better focus 
their efforts on useful data that will drive timely decisions to keep 
patients and staff safe. Similarly, several commenters suggested that 
the change would lead to better and more efficient collection of 
relevant data that can be used to enhance staff and patient safety in 
more rapid fashion.
    Response: We recognize that modern surveillance systems include 
advanced infection detection, data collection and analysis, monitoring, 
and evaluation of preventive interventions. These modern systems and 
practices are consistent with the requirements retained at Sec.  
482.42(a).
    We are aware that many hospitals use automated surveillance 
technology (AST) or ``data mining'' for identification and control of 
hospital-acquired infections (HAI) and implementation of evidence-based 
infection control practices. We believe that the algorithmic analysis 
of electronic health data offers much promise, and we are encouraged by 
the emerging data. (Halpin H, Shortell SM, Milstein A, Vanneman M 
(2011). Hospital adoption of automated surveillance technology and the 
implementation of infection prevention and control programs. Am J 
Infect Control, May;39(4):270-6.) and (Klompas M, Yokoe DS (2009). 
Automated surveillance of health care-associated infections. Clin 
Infect Dis. May 1;48(9):1268-75.).
    We believe that eliminating the burden of having to maintain a 
separate log will provide hospitals with flexibility and free up time 
and resources that could otherwise contribute to patient safety 
efforts.
    Comment: One commenter supportive of the proposed change noted it 
would not alter the current workflow.
    Response: We thank the commenter for this feedback. This confirms 
our understanding that eliminating the requirement for a separate 
infection control log will not negatively disrupt hospital practices.
    Comment: One commenter stressed the importance of recognizing the 
contributions and abilities of hospitals' infection control officers, 
noting that the vast majority of the officers are registered nurses who 
take their roles very seriously and have a very high level of 
professionalism and vigilance.
    Response: We recognize the important contributions to infection 
control made by registered nurses and all health professionals. Indeed, 
success depends on each and every person involved in patient care, as 
so well portrayed in the

[[Page 29057]]

training video ``Partnering to Heal'' (HHS. ``Partnering to Heal.'' 
Accessed 12 January 2012 http://www.hhs.gov/ash/initiatives/hai/training/>).
    Comment: Some commenters expressed support for requirements 
allowing a hospital's infection control officer(s) to develop a system 
for identifying, reporting, investigating and controlling infections 
and communicable diseases of patients and personnel. A few commenters 
remarked upon the importance of a hospital's being able to design its 
own systems, tailoring them to its unique physical environment, 
resources, services and patient population.
    Response: We agree. Apart from proposing to remove the requirement 
for a log at Sec.  482.42(a)(2) and to adjust the formatting and 
numbering of the ``Organization and policies'' standard, we are leaving 
the remainder of this standard unchanged. We continue to believe that 
infection prevention and control efforts must be hospital-wide 
initiatives that take into account each institution's unique 
circumstances.
    Comment: One commenter inquired into the evidentiary basis for or 
our proposal to eliminate the requirement for a log.
    Response: We follow the medical literature on infection prevention 
and control closely, including research on surveillance. As noted 
above, we are aware of emerging technologies, such as automated 
surveillance technology (AST), and of the progress that is being made 
in surveillance and infection prevention and control practices, 
generally.
    Both our understanding of this larger body of research and our own 
observations contributed to our conclusion that advances in infection 
control surveillance systems have made the need for a separate 
infection control log obsolete and to our proposal to eliminate the 
requirement for a separate infection control log. We also gave 
consideration to complaints from stakeholders that the log requirement 
is too prescriptive and burdensome.
    In deciding to finalize our proposal to eliminate the log 
requirement, we would also note the universal support for this proposal 
from several major infection control groups, such as the Infectious 
Diseases Society of America (IDSA), the Association for Professionals 
in Infection Control and Epidemiology (APIC), and the Society for 
Healthcare Epidemiology of America (SHEA).
    Comment: One commenter appeared to view our proposal to remove the 
requirement for a separate infection control log as a larger change to 
retool CMS reporting standards overall. The commenter speculated that 
our proposed changes would lead to the manipulation of data, make side 
by side comparisons nearly impossible and reduce transparency in 
recording and reporting.
    Response: We do not agree that the removal of an outdated 
requirement for a separate infection control log would necessitate any 
additional changes to a hospital's infection control program. Our 
proposal to remove the separate log requirement is a single, targeted 
change to the infection control standard at 42 CFR 482.42(a).
    We note that we have retained all other requirements at Sec.  
482.42, including the requirements at Sec.  482.42(a) which require an 
infection control officer or officers to develop a system for 
identifying, reporting, investigating, and controlling infections and 
communicable diseases of patients and personnel.
    To clarify further, our proposed rule introduced changes to Part 
482 regarding CoPs for Hospitals. In a separate effort, CMS continues 
to employ hospital quality measures and continues its ``Hospital 
Compare'' initiative. See http://hospitalcompare.hhs.gov/. Neither the 
proposed rule nor this final rule touches upon this or any other effort 
by CMS.
    Comment: One commenter stated that our requirements should be 
expanded and improved rather than be eliminated.
    Response: We wish to clarify that we are not lowering our 
standards. As explained above, we believe that eliminating the 
requirement for a separate infection control log merely removes a 
redundancy that, in the modern context, adds cost but no value. We are 
mindful that healthcare-associated infections continue to be a major 
concern and are among the leading causes of death in the United States, 
accounting for an estimated 1.7 million infections and 99,000 
associated deaths in 2002 (Klevens RM, Edwards J, Richards C, Horan T, 
Gaynes R, Pollock D, Cardo D. Estimating Health Care-Associated 
Infections and Deaths in U.S. Hospitals, 2002. Public Health Reports 
2007; 122:160-166.).
    We would like to bring your attention to our efforts through the 
Partnership for Patients program, which was launched in the spring of 
2011 with the twin goals of keeping patients from getting injured or 
sicker and helping patients heal without complication. (HHS. 
``Partnership for Patients'' http://www.healthcare.gov/compare/partnership-for-patients/index.html>).
    We agree with the commenter that there might be room for 
improvement in the regulatory context. We may consider in future 
rulemaking further changes that would include an increased emphasis on 
infection control and prevention; further integration of infection 
control programs with the hospital's QAPI program; better alignment of 
a hospital's infection control efforts with nationally recognized 
guidelines; and a heightened role and accountability for a hospital's 
governing body in infection control program implementation and 
oversight.
    Comment: One commenter suggested that CMS should also require 
protocols and staffing for antimicrobial stewardship as an integral 
component of infection control programs.
    The commenter stated that the issue of antibiotic resistance has 
reached a critical point, as bacteria are becoming increasingly 
resistant to available antibiotics, and new drugs are not being 
developed at a pace necessary to address growing unmet medical needs.
    The commenter also shared its forecast that the costs of including 
antimicrobial stewardship within the CoP related to infection control 
should be more than offset by savings generated. The commenter 
supported its statement by reference to a CDC summary of health 
economic research focused on employing antimicrobial stewardship 
programs with results showing significant cost savings. (CDC Impact of 
Antibiotic Stewardship Program Interventions on Costs. Retrieved Nov. 
3, 2011 from http://www.cdc.gov/getsmart/healthcare/support-efforts/asp-int-costs.html).
    Finally, the commenter suggested that, in a time where critical 
drug shortages have become increasingly more common, an effective 
antimicrobial stewardship program would promote efficient 
administration of appropriate therapies. In the FDA report on Drug 
Shortages released in October of this year, (FDA. ``A Review of FDA's 
Approach to Medical Product Shortages'' Accessed 12 January 2012 
www.fda.gov/DrugShortageReport>), antibiotics were the second largest 
therapeutic drug class to experience shortages, second only to oncology 
agents. The commenter suggested that by eliminating the inappropriate 
use and reducing the over-prescribing of antimicrobial agents, 
stewardship programs will preserve critical therapies that are in short 
supply.
    Response: We thank the commenter for these suggestions. We agree 
that antimicrobial stewardship efforts are an important development in 
the context of infection control. We have not included any 
antimicrobial stewardship requirements in the present final rule. Such 
requirements were not proposed

[[Page 29058]]

and thus cannot be included at this juncture. However, we will consider 
these suggestions in future rulemaking.
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 proposed 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 proposed 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 proposed 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.
    Comment: We received numerous comments offering support for our 
proposal to remove the requirement for hospitals to have a single 
director of outpatient services. Many commenters noted that the change 
would be appropriate, given the complexities of modern hospital 
ambulatory care systems, in which technologies are changing and 
hospitals are increasing their outpatient service offerings. Many 
commenters stressed that the proposed change would free up limited 
resources, and characterized the current requirement as a costly and 
unnecessary administrative burden.
    Some commenters also remarked that the change would help hospitals 
better ensure that individuals with the best expertise will direct each 
particular kind of care provided. Some also commented that the change 
would improve integration of their outpatient services with inpatient 
care while providing greater clarity to the management structure.
    Response: We agree with the commenters that these changes will 
align the hospital CoPs with the current needs and practices of 
hospitals, and we are finalizing this change as proposed. We believe 
that removing the requirement for a single director of outpatient 
services will allow hospitals to better utilize their resources, 
particularly their staffing resources, and align them with the array of 
services they wish to offer.
    Comment: Many commenters also expressly offered their support for 
the proposed regulatory language for hospitals to have ``appropriate 
professional and non-professional employees at each location where 
outpatient services are offered'' and to base this on ``the scope and 
complexity'' of the services.
    Response: We are pleased to have received favorable feedback 
regarding this language. We will finalize this provision as proposed.
    Comment: We received a comment seeking clarification about a 
statement in the proposed rule that ``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.'' This commenter sought clarification as to whether 
the statement encompassed outpatient services provided by critical 
access hospitals and other community partners. The commenter expressed 
strong support for continuity of care and for having agreements in 
place to manage outpatient services and ensure good communication with 
a patient's medical home.
    Response: We wish to clarify that the change to remove the 
requirement for hospitals to have a single director of outpatient 
services applies only to hospitals; it does not apply to critical 
access hospitals (CAHs), which do not have a comparable requirement for 
a single outpatient services director under the CAH conditions of 
participation. We agree that strong coordination with a patient's 
medical home would facilitate the provision of high quality, patient-
centered care.
    Comment: One commenter requested clarification between the CMS 
regulations at Sec.  482.54 regarding Outpatient services and the 
regulations at Sec.  482.12(c) regarding the care of patients. This 
commenter noted that if MD/DOs are required to see every patient, 
regardless of the medical reason for the appointment, then patients 
would be forced to wait for an available appointment when instead they 
could be seen and effectively treated within the scope-of-practice laws 
by a non-physician practitioner who is under a supervisory agreement 
with an MD/DO. The commenter also requested examples of ways in which a 
hospital would demonstrate evidence of a physician's involvement.
    Response: We wish to clarify that the CMS requirements at Sec.  
482.12(c)(1) pertain only to Medicare patients. It should be noted that 
even with regard to Medicare patients, the requirement does not 
prohibit a patient from being treated by a non-physician practitioner 
who is a member of the medical staff and who is acting in accordance 
with his or her State scope of practice as allowed by medical staff 
bylaws, rules, and regulations and by hospital policy. Section 
482.12(c)(1)(i) also contains language that states, ``This provision is 
not to be construed to limit the authority of a doctor of medicine or 
osteopathy to delegate tasks to other qualified health care personnel 
to the extent recognized under State law or a State's regulatory 
mechanism.''
    With regard to the commenter's request for examples of ways in 
which evidence of a physician's involvement would be demonstrated, the 
evidence of a physician's involvement in the care of a Medicare patient 
must be found in the patient's medical record. Examples of medical 
record documentation that support a specific physician's involvement in 
the care of a Medicare patient include, but are not limited to: the 
physician's name listed as the attending physician or physician of 
record; orders, progress notes, or H&Ps/updates authenticated by the 
physician; and any other documentation that could reasonably support a 
specific physician's involvement in the care of the patient.
8. Transplant Center Process Requirements--Organ Recovery and Receipt 
(Sec.  482.92)
    The transplant center rule at Sec.  482.92(a) and the Organ 
Procurement Organizations (OPO) rule at Sec.  486.344(d)(2)(ii) and 
Sec.  486.344(e) set forth requirements regarding blood type and other 
data verification, as well as documentation procedures.
    We proposed 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 proposed 
to redesignate paragraphs (b) and (c) as (a) and (b), respectively. 
This would eliminate the requirement for a separate blood type and 
other vital data verification by a recovery team sent by a transplant 
center to recover an organ(s), if the intended recipient is known 
before organ recovery.

[[Page 29059]]

    Comment: All of the comments were supportive of this requirement's 
removal. The commenters indicated that this requirement was redundant 
with the requirements in the OPO Conditions for Coverage (CfCs), 
unnecessary, and would not impact patient safety. They also indicated 
that the requirement was difficult to monitor and that the intended 
recipient could change before the organ was actually transplanted.
    Response: We agree with the commenters that Sec.  482.92(a) is 
redundant with the OPO CfCs. Section 486.344(d)(2)(ii) requires OPOs to 
compare the blood type of the donor with the blood type of the intended 
recipient prior to organ recovery, if the identity of the intended 
recipient is known. We will delete the current Sec.  482.92(a) and 
redesignate the remaining subsections as (a) and (b). Thus, we have 
finalized the section as proposed.
    Comment: One commenter did state that while they supported the 
removal of this requirement, multiple checks of blood type were 
required in light of recent medical errors concerning organ 
transplantation.
    Response: We also agree with the commenter that multiple blood type 
checks are necessary to avoid errors in the transplantation of organs. 
In addition to the requirement for OPOs to check the blood type of the 
donor and the intended recipient as described above, transplant 
surgeons and another licensed health care professional must verify that 
the donor's blood type and other vital data are compatible with the 
intended recipient after the organ arrives at the transplant center 
(current Sec.  482.92(b) and new Sec.  482.92(a)). Thus, after removal 
of Sec.  482.92(a), there are two mandatory checks to ensure that the 
blood type and other vital date of the donor and the intended recipient 
are compatible. This must be done for both deceased and living donors 
(Sec.  482.92(a) and (b)--as redesignated in the final rule).
Additional Comments Received Beyond the Scope of This Rulemaking
    Comment: We received one comment suggesting that CMS clarify the 
outcome measures in the hospital CoPs for transplant centers. That 
commenter indicated that while the final rule for those requirements 
incorporated risk adjustment with regard to outcome requirements used 
to approve and re-approve transplant centers, they stated that the 
nature of the risk adjustment may not be fully appreciated. They 
believed that concerns related to the regulatory burden of these 
outcome requirements, while perhaps unwarranted, might be contributing 
to an unintended consequence of a sound public policy, namely a 
seemingly high organ discard rate.
    Response: We appreciate the comment and the comment's concern. 
However, this comment is outside the scope of the proposed rule. 
Therefore, we not made any changes to the provision based on this 
comment.
9. 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.
    We proposed to eliminate the requirement at Sec.  485.635(b) that 
CAH staff must provide certain services directly and proposed to change 
the heading of the standard, ``Direct services,'' to ``Patient 
services.'' We also proposed to revise the language in paragraphs Sec.  
485.635(b)(1) through (b)(4), ``that the CAH staff furnishes as direct 
services.'' We also proposed to eliminate the definition of ``Direct 
Services'' at Sec.  485.602 since it will no longer be applicable.
    We noted that 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.
    Comment: The majority of commenters supported the proposed change, 
stating that it will allow CAHs more flexibility in meeting the needs 
of their communities with limited resources. This change will better 
enable CAHs to address staffing challenges, provide high-quality care 
to their patients, and provide CAH patients better access to care. A 
few commenters stated that allowing CAHs the flexibility in providing 
these services for their community while still maintaining 
responsibility and oversight for the services can generate cost savings 
that could be reallocated to other areas, such as quality improvement 
and patient safety.
    One commenter expressed concerns that having non-employed providers 
may delay care and would urge caution in this area.
    Response: We appreciate the comments supporting the rule and the 
comment that expressed concern regarding any potential delay in care. 
As stated by the majority of commenters, we believe that this change 
will enable CAHs to address staffing issues and to provide better 
access to quality health care. However, with this revision to provide 
CAHs with the flexibility to contract or arrange for patient services, 
we expect CAHs to ensure that they provide services that would 
facilitate timely diagnosis and treatment of their patients, as 
envisioned by the statute. We expect that delivering timely services 
will be best achieved by providing CAH services on-site at the CAH as 
much as possible, whether through CAH employees or through a contract 
or arrangement. At a minimum, we expect the services listed under Sec.  
485.635(b) to be offered by the CAH on-site.
    Comment: Several commenters stated that this change will provide 
for greater partnerships with other local providers. One commenter 
stated that if CAHs are allowed to contract for services provided, CMS 
should state that a high preference is for CAHs to contract with other 
federally funded and designated programs like Federally Qualified 
health Centers (FQHCs), FQHC Look-Alikes, Rural Health Clinics (RHCs), 
and the health departments. One commenter stated that a CAH that sought 
to expand outpatient services should have to validate that there was a 
community need for the services it planned to deliver and submit a 
letter of support from all essential community providers validating 
that collaborative partnership with essential community providers had 
been developed and would be maintained. The commenter also stated that 
any CAH that sought to expand outpatient services should submit data 
annually to CMS regarding the cost, utilization, and outcomes of 
patient services delivered and that CMS should make this data available 
to the general public on an annual basis.
    Response: We do not have the authority under Federal law to require 
CAHs to enter into contracts or arrangements for patient care services 
rather than provide them directly, or to require them to give 
preference in their contractual arrangements with certain types of 
Medicare-participating suppliers, such as FQHCs or RHCs. We also see no 
valid reason related to quality of care or patient safety for CAHs to 
have to bear the burden of justifying the need for additional 
outpatient services before the CAH may offer them. With respect to CAHs 
collecting and submitting data to us for

[[Page 29060]]

us to make public on their outpatient services, we already have in 
progress the development of measures of outpatient quality of care for 
publication on our Hospital Compare Web site, and are examining ways to 
include CAHs in future reporting. We agree with the commenters that 
removal of the requirement for certain services to be direct services 
will provide for greater partnerships with other local providers and 
suppliers, and we believe that CAHs will appropriately utilize the 
services of all providers and suppliers in their communities.
    Comment: One commenter suggested that we eliminate the reference to 
``direct services'' from the CAH standard at Sec.  485.623(a), which 
states that the CAH is constructed to ensure access and to provide 
adequate space for the provision of direct services.
    Response: Since we have proposed to eliminate the requirement that 
CAHs must provide services directly with CAH staff, and we have removed 
the definition for direct services at Sec.  485.602, we agree with the 
commenter that we should remove the reference to ``direct services'' at 
Sec.  485.623(a). We will also make a similar change to remove the 
reference to direct services at Sec.  485.635(a)(3)(i), which requires 
the CAH's policies to describe all services the CAH furnishes directly 
and through agreement or arrangement.
Additional Comments Received Beyond the Scope of This Rulemaking
    Comment: While we did not propose a change to this provision, some 
commenters requested reconsideration and revision of the requirement 
that CAH patient care policies and procedures be reviewed annually. 
They stated that policy review is extremely time consuming and 
requested that a biennial review, or longer which would be preferable.
    Response: We appreciate the comments. However, this comment is 
outside the scope of the proposed rule and no changes will be made to 
this provision. We may consider these comments when undertaking future 
rulemaking.

B. Clarifying Changes

10. Pharmaceutical Services (Sec.  482.25) and Infection Control (Sec.  
482.42)
    In both Sec.  482.25(b)(6) and Sec.  482.42(b)(1) we proposed to 
replace the term ``quality assurance program'' with the more current 
term ``quality assessment and performance improvement program'' to 
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.
    Comment: We received a few comments agreeing with the technical 
changes to replace the quality assurance term with the more current 
term ``quality assessment and performance improvement program.''
    Response: We appreciate the support for these technical changes and 
will finalize the rule as proposed.
Additional Comments Received Beyond the Scope of CMS-3244
    Comment: Several commenters recommended that we change the 
requirement to state that the professional responsible for the patient 
or who ordered the medications should also receive the report regarding 
pharmaceutical drug error, adverse event, or incompatibility issues. 
They stated that this would facilitate timely reporting to a Certified 
Nurse Midwife caring for a patient during labor and delivery, or to a 
nurse practitioner or physician assistant caring for a patient in the 
emergency room. Another commenter stated that the pharmacy department 
should be included in the development of criteria for pharmacist 
privileging decisions. One commenter questioned the timeframe for 
immediately reporting to the attending physician.
    Response: We appreciate the comments. However, these comments are 
outside the scope of the proposed rule and no changes will be made to 
this provision. We may consider these comments when undertaking future 
rulemaking.
    Comment: One commenter stated that we need to clarify changes to 
the quality assessment and performance improvement CoP.
    Response: We did not propose to make any changes to the quality 
assessment and performance improvement CoP at Sec.  482.21. We only 
proposed to make conforming changes to the pharmaceutical services CoP 
by replacing the term ``quality assurance program'' with the current 
term ``quality assessment and performance improvement (QAPI) program'' 
that is under the QAPI program CoP.
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 nurse specialist. In this rulemaking, we proposed to 
revise the definition of a clinical nurse specialist (CNS) at Sec.  
485.604(a) to reflect the definition in the statute at Sec.  
1861(aa)(5)(B). Specifically, we proposed 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.
    Comment: A majority of commenters supported the proposed change. 
However, most of these commenters recommended that we include in the 
definition that the CNS be a registered nurse with a nursing degree at 
the master's or doctoral level from an accredited educational 
institution and authorized to practice based on State nurse licensing 
laws and regulations. They stated that this change will allow a CNS to 
practice in either the State in which they live or the State in which 
they provide services. Commenters also noted that not all advanced 
clinical degree nursing programs include the phrase ``CNS'' in their 
degree titles. Boards of Nursing in 38 States have determined the 
educational and practice requirements for individual programs prior to 
granting the title to work as a clinical nurse specialist in their 
States. The commenters stated that adding the language regarding State 
nurse licensing laws and regulations allows the State Boards of Nursing 
to determine whether the nurses' educational program is congruent with 
a CNS education. A few commenters stated that it is critical that 
language in the final regulation provide recognition of all existing 
CNSs, and in particular, those who practice in the area of mental 
health. One commenter recommended that we require CNSs to be certified 
by a national organization. However, the commenter also stated that 
they recognize the need to allow flexibility for States that do not yet 
require certification as a requirement for CNS practice and, at this 
time, it would be unfair to require that all CNSs be certified.
    Response: We appreciate all of the comments supporting the proposed 
definition change as well as the suggestions for improving it. We will 
change the definition at Sec.  485.604(a) to state that the term 
``clinical nurse specialist'' is a registered nurse and is licensed to 
practice nursing in the State in which the clinical nurse specialist 
services are performed in accordance with State nurse licensing laws 
and regulations; and holds a master's or doctoral level degree in a 
defined clinical area of nursing from an accredited educational 
institution. Adding the phrase ``in accordance with State nurse 
licensing laws and regulations'' will ensure that an existing CNS will 
continue to be evaluated based

[[Page 29061]]

on their State licensing laws and regulations. We agree with the 
commenter that it would be unfair to require national certification for 
CNSs and we will not require such certification. We believe that 
requiring CNSs to have a graduate level education and to be authorized 
to practice based on State nurse licensing laws and regulations reflect 
the statutory definition of a CNS.
12. Surgical Services (Sec.  485.639)
    The current surgical services CoP at Sec.  485.639 was promulgated 
in 1995 (60 FR 45814, September, 1, 1995) to ensure adequate health and 
safety protection for patients. The provision of surgical services is 
not a required CAH service under the Act at section 1820(c); therefore, 
we proposed to change the introductory text before this CoP to clarify 
that surgical services are optional services for CAHs. We proposed to 
add the conditional clause, ``If a CAH provides surgical services,'' at 
the beginning of the introductory text. Also, to reflect the 
organizational structure CoP at Sec.  485.627, we proposed to include 
the phrase, ``or responsible individual.'' 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.''

    Comment: The majority of commenters supported the change clarifying 
the language regarding surgical services as an optional service. One 
commenter asked whether this rule change could lead to certain CAHs 
eliminating surgical services without giving thought to an alternative 
source for such services.
    Response: We would like to clarify that this is not a substantive 
change in the regulation. CAHs are currently not required to provide 
surgical services. We proposed to revise the introductory statement to 
the CoP to clarify that CAHs are not required to provide surgical 
services. However, if a CAH provides surgical services, the CAH must 
comply with the surgical services CoP at Sec.  485.639. Current CAHs 
should already be aware that this is an optional service and we do not 
believe that providing this clarifying language will result in a CAH 
eliminating their surgical services. In fact, we believe that 
clarifying the regulations that surgical services are optional will 
assist small rural hospitals that may be considering whether to seek 
CAH status. Therefore, we will finalize our proposed technical change.
Additional Comments Received Beyond the Scope of This Rulemaking
    Comment: A few commenters stated that CMS should consider 
modification to the provisions at Sec.  485.639, Anesthesia services, 
and require supervision of CRNAs to be consistent with State licensure 
requirements and elimination of the opt-out provision at Sec.  
485.639(e). Another commenter stated that CMS should reevaluate the 
physician supervision for CRNAs in CAHs and hospitals. There should be 
ongoing research regarding the need for the existing supervision 
requirements in the CoPs.
    Response: We appreciate the comments. However, this comment is 
outside the scope of the proposed rule and no changes will be made to 
this provision.

C. Other Options Considered

    In the proposed rule (76 FR 65891), we discussed alternative 
options for revisions that we considered, but did not propose. We also 
solicited comments and suggestions on additional reforms that would 
reduce burden on hospitals. Below are our responses to public comments 
on those alternatives, as well as a summary of additional 
recommendations submitted by commenters. See the October 24, 2011 
proposed rule (76 FR 65891) for a detailed discussion of the other 
options we considered.
Medical Staff (Sec.  482.22)
    In the proposed rule (76 FR 65899) we stated that we had 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 the hospitals in the system. We also considered, based on 
stakeholder feedback, 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. We received many 
comments on these considerations, and responses to comments received 
for this section can be found below.
    Comment: A number of commenters responded to our solicitation of 
comments on whether we needed to revise the Medical staff CoP at Sec.  
482.22 to further clarify that each hospital must have its own medical 
staff within a multi-hospital system, and there may not be a single 
medical staff for all of the hospitals within the system.
    However, many of the comments reflected some confusion over our 
discussion of this issue. Some commenters interpreted our discussion as 
a proposal to allow a single medical staff for a multi-hospital system. 
In the proposed rule, we stated, ``We do not believe that the current 
CoP language implies that we require a single and separate medical 
staff for each hospital within a multi-hospital system'' (76 FR 65899). 
We stated this in order to point out the current language's potential 
ambiguity, not to propose a change in our interpretation of it. We 
continue to interpret the current CoP to require that each hospital, 
regardless of whether it is a part of a multi-hospital system, have a 
single and separate medical staff, as a matter of CMS policy.
    Nevertheless, a number of comments supported a revision to the 
current requirement to allow for a single medical staff for hospitals 
in a multi-hospital system. Some commenters stated that it would be 
more efficient and save on resources for hospitals, particularly with 
regard to practitioner credentialing and privileging. Many commenters 
pointed to the potential for patient safety initiatives and quality of 
care improvements across multiple hospitals within a system if these 
programs were developed and overseen by a single medical staff. A few 
commenters expressed support for the idea only if it applied to smaller 
hospital systems confined to a more limited geographic area where many 
of the medical staff would be located close enough to be privileged at 
all of the hospitals in the system. These commenters were generally 
opposed to a single medical staff for large hospital systems that 
spanned multiple States.
    A significant number of comments expressed opposition to the 
concept of a single medical staff responsible for the oversight of 
practitioners and the quality of patient care at multiple hospitals 
within a system. These commenters stated that such a proposal would 
undermine the fundamental idea behind a medical staff: self-governance. 
The commenters explained the concept of medical staff self-governance 
as one in which the medical staff is familiar with the practitioners 
whom it governs and is comprised of, understands the unique needs of 
the hospital in which the practitioners work, and ``can nimbly respond 
to health and safety issues that arise with respect to those patients 
and that hospital.'' The commenters pointed

[[Page 29062]]

out that medical staff self-governance is required by a hospital 
accrediting organization and is also mandated by some States and they 
questioned whether self-governance requirements would be met if a 
multi-hospital system was allowed to have a single medical staff 
overseeing an unlimited number of hospitals spread out over a wide 
geographic area and ``without the meaningful input of the physicians at 
each member hospital.'' Commenters further cited the negative impact 
that such a proposed change would have on peer review whereby the 
single medical staff at the headquarter hospital of the system (for 
example, a large urban tertiary care center) would review practitioners 
at a member hospital (for example, a rural hospital or a pediatric 
hospital) without having any first-hand knowledge or experience with 
the member hospital, its patient population, and its particular medical 
care needs. Finally, they pointed to the potential for conflict with 
current State peer review laws and regulations that such a change might 
create.
    Response: We appreciate all of the comments received on this issue 
and apologize for any confusion that may have been caused by the 
ambiguous statement in the preamble to the proposed rule. We continue 
to agree with the commenters who opposed any changes to the current 
requirement that might allow for a single medical staff to oversee all 
hospitals within a multi-hospital system. We believe that the concerns 
of the commenters are valid, particularly with regard to medical staff 
self-governance, peer review, and accountability for patient care, and 
agree with the commenters that such a change in current requirements 
and interpretation could negatively impact the health and safety of 
patients. Therefore, as we previously stated in the preamble discussion 
of the proposed rule, we are retaining the current Medical staff 
requirement without revision and maintain our historical position that 
each hospital, even those in a multi-hospital systems, must have its 
own medical staff with the authority and responsibility for the quality 
of patient care provided in that hospital.
    Comment: Some commenters supported keeping the hospital CoPs at the 
service/departmental level. Commenters suggested that the current 
departmental structure of the CoPs leads to a more fragmented and 
uncoordinated approach to delivering care; therefore, by arranging 
quality and safety requirements into systems of care, hospital staff 
would be likely to work as a team in developing care processes and 
systems that meet the requirements. Therefore, commenters urged CMS to 
move to a more system based approach for organizing the hospital CoPs. 
Other commenters suggested that CMS allow flexibility in organizational 
structure and requirements. Other commenters believed an organizational 
structure of the CoPs, reflecting areas of service, would be the most 
efficient; and in line with today's clinical management philosophy. The 
structure would enable the hospitals to improve care delivery and the 
quality and safety of patient care. Some commenters supported revising 
the overall organizational structure of the CoPs to condense 
regulations for departmental leadership into a single non-specific 
regulation. One commenter supported elimination of current specialty-
department-specific leadership requirements into a single, non-specific 
CoP.
    Response: We appreciate commenters' suggestions. These comments 
were outside the scope of this final rule, and we may consider these 
suggestions in future notice-and-comment rulemaking.
Medical Record Services (Sec.  482.24)
    In the proposed rule (76 FR 65899), we considered modifying the 
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. We did not believe that the regulation should be amended, and 
specifically sought public comment on this issue. The following are 
responses to public comments received.
    Comment: Several commenters supported our decision to not amend the 
current history and physical examination (H&P) provision, or its 
associated IG, contained under the Medical record services CoP at Sec.  
482.24(c)(2). Commenters stated that the language at Sec.  482.24(c)(2) 
is clear and that it needs no further explanation. Other commenters 
agreed that it is appropriate to defer to the clinical judgment of the 
hospital staff to determine the extent of the necessary update.
    Response: We appreciate the support of commenters on this issue and 
we agree that this provision does not need any further regulatory 
clarification. As we stated following our explanation of this provision 
and its IG in the proposed rule, we do not believe that the regulation 
should be amended.
    Comment: Some commenters were concerned with what they saw as a 
rigid interpretation of the H&P requirement and stated that it causes 
unnecessary burden by not clarifying that H&Ps conducted within the 24 
hours prior to an admission or registration are not necessary and that 
they should be left to the discretion of the clinician. One commenter 
recommended that CMS clarify its parameters for the timeframe related 
to an H&P update (for example, the value of performing updates to H&Ps 
that are completed shortly before a scheduled procedure requiring 
anesthesia services). In addition, it was suggested by a commenter that 
some surveyors continue to confuse the timeframe requirements for H&Ps 
with those for the pre-anesthesia evaluation. Another commenter 
suggested that CMS clarify this requirement to specify what constitutes 
an update of H&P to ensure that hospitals are complying appropriately 
with this requirement.
    One commenter noted that the current H&P requirement allows only 
physicians to conduct H&Ps, which could result in delays in diagnosis 
and treatment in areas where there are not enough physicians. The 
commenter recommends that Sec.  482.24 be modified to include PAs and 
APRNs. Another commenter was concerned that the wording of the current 
requirements may not fully recognize the ability of nurse practitioners 
to perform both the initial H&P and the subsequent reassessment of the 
patient after admission or registration, provided that the nurse 
practitioner is credentialed and privileged to perform these patient 
evaluations. Therefore, the commenter continued, future regulations and 
IGs should specifically clarify the authority of nurse practitioners to 
perform these evaluations. Another commenter stated that permitting an 
out-of-hospital H&P by a non-physician to substitute as the basis for 
hospital admission and treatment, instead of an H&P by a physician on 
the hospital medical staff, would create an unacceptable danger to 
patients since these non-physicians would be exempt from medical staff 
credentialing, privileging, and peer review. The commenter further 
stated that non-physicians often lack the education, training, 
experience, or licensure to perform a proper H&P for patients who are 
seriously ill. Another commenter stated that the following 
interpretation of this regulation needs to be clearly communicated to 
all: That a current H&P can be included in the patient's medical record 
if performed within 30 days prior to hospital admission; these H&Ps may 
be performed by any licensed independent practitioner (including 
Doctors of Podiatric Medicine) who is or is not a member of the medical 
staff, provided

[[Page 29063]]

that this does not substitute for proper clinical judgment related to 
updating the patient's status; and that, after the patient is admitted, 
all necessary H&Ps must be performed by a properly privileged and 
credentialed member of the medical staff as needed. One commenter 
stated there was confusion over the H&P update in that some physicians 
feel this rule compels them to do a full H&P (the commenter stated that 
this was the advice given by legal counsel), especially if the first 
one was not done by them.
    One commenter supported the review of H&Ps conducted within the 30 
days prior to hospitalization; however, the commenter encouraged CMS to 
allow organizations flexibility in documenting that review and that CMS 
should not prescribe the specific language or method to be used to 
indicate that the patient was re-examined and the results are noted 
(for example, ``the H&P was reviewed, the patient was examined, and `no 
change' has occurred since the H&P was completed''). Another commenter 
was in agreement with the language of the H&P requirement, but noted if 
an update exam is needed it should be required by hospital policy 
rather than by CMS regulations. Some commenters noted that there is 
inconsistent application of H&P requirements by CMS and TJC. One 
commenter suggested that it would be very helpful if CMS would allow 
hospitals to address H&P requirements in the medical staff rules and 
regulations or policies.
    Response: While we appreciate the various dissenting comments and 
opinions that we received on the H&P requirements, we must point out 
that many of these comments contained inaccuracies regarding both the 
requirements and the IGs. As such, the comments do not offer 
constructive criticism or evidence of a compelling need to revise the 
H&P requirements or the H&P IGs.
    The intent behind this requirement has always rested firmly on the 
basic purpose of an H&P (and a subsequent update to an H&P)--that is, 
to determine whether there is anything in the patient's overall 
condition that would affect the planned course of the patient's 
treatment, such as an allergy to a medication that must be avoided, or 
a co-morbidity that requires certain additional interventions to reduce 
risk to the patient. To question ``the value of performing updates to 
H&Ps that are completed shortly before a scheduled procedure requiring 
anesthesia services'' is to question the value of performing an H&P in 
the first place. A patient's condition can change day to day, moment to 
moment. The update requirement ensures that any change in a patient's 
condition is noted and taken into consideration prior to a practitioner 
beginning a procedure or starting a treatment plan that may be affected 
by such a change. The H&P and its update give the practitioner as much 
information about the patient as he or she chooses to seek prior to 
beginning treatment. As written, the requirements and IGs allow the 
practitioner performing the update to exercise his or her independent 
clinical judgment with regard to how minimal, how focused, or how 
extensive the update to the H&P should be for a particular patient (71 
FR 68676; http://www.cms.gov/manuals/downloads/som107ap_a_hospitals.pdf).
    With regard to the comment that the requirements limit the 
performance of the H&P and its update to physicians, the requirements 
(under the Medical staff bylaws provisions at Sec. Sec.  
482.22(c)(5)(i)-(ii)) have always been explicit that other qualified 
licensed individuals may perform these evaluations. Other qualified 
licensed individuals are those licensed practitioners (such as APRNs 
and PAs) who are permitted by their State scope of practice laws or 
regulations to conduct a history and physical examination (and any 
updates to it), and who are also formally authorized by the hospital to 
conduct an H&P and its updates. Therefore, we do not agree that we need 
to clarify that these types of practitioners can perform these duties.
    Conversely, there was the comment that posited the idea that 
allowing these types of practitioners to perform H&Ps and updates poses 
an ``unacceptable danger to patients'' since these nonphysician 
practitioners ``often lack the education, training, experience, or 
licensure to perform a proper H&P for patients who are seriously ill.'' 
The commenter also stated that non-physician practitioners who perform 
H&Ps prior to admission (for example, as part of a primary care 
practice) and who are not on the medical staff would be exempt from 
medical staff credentialing, privileging, and peer review. While the 
fact that non-medical staff APRNs and PAs are exempt from medical staff 
peer review is certainly true (and, for that matter, so it would also 
be for non-medical staff physicians), it cannot be assumed that the 
quality of the H&Ps would be any less than those performed by medical 
staff APRNs, PAs, and physicians. However, the practitioner responsible 
for the care of the patient always has the option to perform a new H&P 
if he or she feels that the H&P done prior to admission or registration 
by the patient's primary practitioner is less than adequate.
    Finally, the language in the IGs regarding what a practitioner 
might write in the medical record for a patient requiring an update to 
his or her H&P, but having no changes in his or her condition, is not 
intended to be prescriptive. It is provided as merely an example.
Physical Environment (Sec.  482.41)
    Currently, hospitals are required to meet the standards of the 2000 
edition of the Life Safety Code (LSC). In the proposed rule (76 FR 
65899-65900), we noted the 2012 LSC edition was expected for release in 
fall 2011, and based on the 2012 edition's content we would decide 
whether it or another more recent edition was appropriate for 
incorporation into regulations for hospitals and other affected 
providers and suppliers. We also noted any regulatory changes would be 
addressed through separate notice-and-comment rulemaking; and asked the 
public for their comments in regard to LSC (76 FR 65900). The 2012 LSC 
has been subsequently released since the publication of this proposed 
rule.
    Comment: Many commenters recommended the adoption of the Life 
Safety Code (LSC) (2012 edition) in Physical environment Sec.  482.41. 
Many commenters also suggested that CMS could ensure continued 
relevance of its LSC requirements by mandating that hospitals comply 
with the most current LSC requirements, rather than reference a 
specific edition of the LSC as it has previously done. A few commenters 
urged CMS to adopt the 2009 edition of the LSC. One commenter suggested 
CMS adopt the version of the LSC that the State Fire Marshal is using 
for that particular State. One commenter stated at the time CMS 
considers updating the LSC, that both the 2009 International Building 
Code and International Fire Code be considered as an allowable means of 
meeting the fire and life safety requirements at Sec.  482.41. A few 
commenters noted that currently multiple authorities have jurisdiction 
over hospitals and may use different versions of the LSC, which creates 
substantial burden on hospitals and confusion in the field. Some 
commenters also recommended that the Health Care Facilities Code 
(National Fire Protection Association (NFPA) 99-2012) should also be 
adopted. One commenter asked whether a fire alarm system installed in 
2000 would have to be in compliance with the maintenance, inspection, 
and testing rules of the 2000 or the 2012 edition of the NFPA 72.

[[Page 29064]]

    Response: We appreciate commenters' suggestions regarding the LSC 
regulations set out under our ``Physical environment'' CoP at Sec.  
482.41. Suggestions received were outside the scope of this final rule 
and will be considered through separate notice-and-comment rulemaking 
in a LSC omnibus rule, targeted for publication in the near future.
Public Comments Regarding Possible Areas for Future Rulemaking
    The proposed rule (76 FR 65904) solicited any additional public 
comments on the hospital CoPs which were beyond that of the proposed 
provisions. Many commenters provided public comments that were outside 
the scope of this final rule, and below is a summary of responses to 
those public comments received.
Interpretive Guidelines (IGs)
    One commenter suggested that CMS should provide easy access to up-
to-date hospital CoPs and IGs on the CMS Web site (instead of rewriting 
hospital CoPs in another format), and support a more robust search 
engine for users. Other commenters suggested that CMS revise the way in 
which it develops changes to IGs to allow for meaningful stakeholder 
and subject matter expert input, making the process more transparent. 
Other commenters suggested that accrediting bodies should have an 
opportunity to review and provide comment on new and modified IGs 
before they are released in a Survey and Certification Director's 
letter. Another commenter suggested that the IGs should be reviewed 
annually, at a minimum, to allow for meaningful input. Commenters 
believed there should be a complete review of the CoP's IGs, as they 
are believed to have become overly wordy, burdensome, and subject to 
inconsistent interpretation (for example, the new IG on anesthesia 
includes analgesia which goes beyond the limits of the regulation, 
etc.). One commenter suggested that there is a need for the IGs to be 
very explicit regarding processes for credentialing and privileging 
non-licensed independent practitioners. In addition, commenters 
encouraged CMS to conduct more robust training for State survey 
personnel to ensure consistent interpretations of the IGs during 
surveys.
Immediate Jeopardy
    Commenters urged that CMS further define immediate jeopardy, as 
well as the process in place to apply immediate jeopardy to value-based 
purchasing. Additionally, commenters suggested that CMS should explain 
the process in place to guarantee that consistent standards, across the 
nation, will be used to evaluate situations in which immediate jeopardy 
is suspected.
Privacy Standards
    Commenters noted the comprehensive HIPAA standards, not the general 
CoP provisions, provide the appropriate basis for protecting the 
privacy and security of patient medical information without inhibiting 
the coordination of patient care. Commenters further recommended that 
CMS eliminate the CoP obligations for medical records confidentiality 
for providers, and instead rely on the Office of Civil Right's 
interpretation, oversight and enforcement of the compliance obligations 
under the HIPAA privacy and security standards.
Nuclear Medicine
    One commenter suggested modifications to Nuclear medicine at Sec.  
482.53(b)(1) to remove the word ``direct'' to reflect the delegation 
authority of the authorized user. Additionally, the commenter suggested 
the IGs regarding Sec.  482.53(b)(1) should be enhanced focusing on the 
term ``authorized user'' (for example, CMS to allow the authorized user 
be given the authority, as noted and consistent with the Nuclear 
Regulatory Commission guidelines, to delegate specific tasks, as they 
are best suited for determining tasks that supervised individuals can 
perform and the degree of supervision required; further the authorized 
user should put policies in place to clarify the specific tasks 
delegated and the supervision and certification necessary for each), 
certification of uniform competencies, radiopharmaceutical preparation 
qualifications, relevant practice standards, and certification 
assessments rather than layering staff. One commenter suggested that 
the Nuclear medicine CoP and IGs be updated in the future rulemaking.
Radiologic Services
    Commenters suggested that patient-directed care is not adequately 
recognized in the CoPs, and that CMS should amend Radiologic services 
at Sec.  482.26(b)(4) to be consistent with State law for those 
services permitted to be self-referred by hospital patients.
Special Provisions Applying to Psychiatric Hospitals
    One commenter suggested that CMS review the CoP at Sec.  482.60, 
Special provisions applying to psychiatric hospitals. Specifically, the 
commenter suggested modifications to the current provisions at Sec.  
482.61(b) stating more flexibility for professional judgment regarding 
the breadth and depth of assessments should be allowed through the 
development of hospital-specific policies rather than requirements of 
CoPs; Sec.  482.61(c) stating there are other ways to assure that 
patients are receiving appropriate treatment modalities with sufficient 
frequency and intensity to justify inpatient treatment than are 
currently required by the CoPs; and Sec.  482.62(a) suggesting that the 
provision of interdisciplinary treatment can be accomplished in many 
ways and that hospitals should be encouraged to provide that treatment 
in the most flexible and efficient way possible, based on individual 
patient needs and hospital policy.
Emergency Services
    One commenter suggested telemedicine modifications to Sec.  
482.55(b)(2), Emergency services, to add ``available in-person or by 
video conferencing.'' The commenter also suggested incorporating a new 
provision to allow hospitals to provide access for stroke care through 
telemedicine at Sec.  482.55 to state ``there must be adequate medical 
personnel, available in-person or by video conferencing, qualified in 
ischemic stroke diagnosis to order appropriate treatment including 
timely thrombolytic therapy where appropriate.''
Intensive and Critical Care Services
    One commenter suggested adding a new CoP at Sec.  482.58 for 
intensive and critical care services, to be modeled on the emergency 
services provision at Sec.  482.55.
Discharge Planning
    One commenter recommended revisions at Sec.  482.43(b)(3), 
Discharge planning, that would include the patient's risk of 
readmission for the diagnosis by adding text that states ``patient's 
readmission for related care and * * *''.
Regulations Governing Graduate Medical Education
    One commenter believed the rules lead to additional cost and make 
it more difficult to administer responsive, quality graduate medical 
education programs, especially in regards to integrated healthcare 
systems.
Regulations Governing Quality Measurement
    One commenter stated that over the years there has been a 
proliferation of quality measures across provider types; therefore, 
this commenter suggested that CMS consider a periodic review of all

[[Page 29065]]

measures to ensure that there is as little administrative burden as 
possible, that the measures are compatible from entity to entity, and 
that the measures move the program in the same direction rather than 
splinter providers' focus.
Electronic Health Records (EHRs)
    Commenters suggested CMS consider how to incorporate EHRs into the 
CoPs and IGs.
Payment
    Several commenters urged CMS to reevaluate payment. A few 
commenters stated they did not understand the rationale for CMS to 
impose stricter supervision regulations under the Outpatient 
Prospective Payment System (OPPS) rule, in that direct supervision is 
not a requirement for inpatient services when the patient is presumably 
more acutely ill, so to impose director supervision for outpatient 
therapeutic services is not clinically sensible.
Future Rulemaking Affecting CoPs
    One commenter recommended that CMS provide guidance about how 
future rulemakings affecting CoPs or other programs will increasingly 
seek to incentivize evidence-based care processes that integrate 
patients and families into care decision-making and clinical workflow.
    Response: Thank you for the suggestions. These comments were 
outside the scope of this final rule, and we may consider these 
suggestions in future notice-and-comment rulemaking and/or through the 
IGs.
Food and Dietetic Services
    Comment: One commenter suggested CMS consider revising the 
requirement for a paper-based therapeutic diet manual, in Food and 
dietetic services Sec.  482.28, and allow organizations a more 
contemporary approach for staying current with nutritional guidelines 
(for example, that facilities should be allowed the flexibility to 
utilize knowledge-based information in a variety of forms as a means of 
staying current, as opposed to utilizing a hard-copy manual, which does 
not allow organizations to keep up with rapid changes in the field.).
    Response: Currently, the CoP at Sec.  482.28(b)(3) does not 
specifically require a ``paper-based'' therapeutic diet manual. The 
current CoP at Sec.  482.28(b)(3) states, ``A current therapeutic diet 
manual approved by the dietitian and medical staff must be readily 
available to all medical, nursing, and food service personnel.'' We 
will take this comment into consideration for future rulemaking.

III. Provisions of the Final Rule

    In this final rule, we are adopting the provisions of the October 
24, 2011 proposed rule (76 FR 65891) with the following revisions, 
which will apply to hospitals and CAHs, based on public comments:

Governing Body (Sec.  482.12)

     In response to public comments, we are revising the 
introductory text to add a requirement at Sec.  482.12 that the 
governing body must include a member, or members, of the hospital's 
medical staff.

Patient's Rights (Sec.  482.13)

     We are revising paragraph (g)(2) to delete the phrase, 
``report to CMS,'' and to clarify that for those deaths related only to 
soft, two-point wrist restraints the hospital staff must record the 
information regarding the patient's death in an internal log or other 
system.
     We are revising paragraph (g)(2) and (g)(4) to clarify 
that the log is internal to the hospital.
     We are revising paragraph (g)(3) to specify that ``The 
staff must document in the patient's medical record the date and time 
the death was: (i) Reported to CMS for deaths described in paragraph 
(g)(1); or (ii) Recorded in the internal log or other system for deaths 
described in paragraph (g)(2).''
     We are revising paragraph (g)(4)(ii) to specify that each 
entry must document the patient's name, date of birth, date of death, 
``name of attending physician or other licensed independent 
practitioner who is responsible for the care of the patient as 
specified under Sec.  482.12(c),'' medical record number, and primary 
diagnosis(es).

Medical Staff (Sec.  482.22)

     Remove proposed paragraph (a)(5).
     Revising paragraph (a) to change the title of the standard 
from ``Composition of medical staff'' to ``Eligibility and process for 
appointment to medical staff,'' and require that the medical staff must 
include doctors of medicine or osteopathy, but may also include other 
categories of non-physician practitioners determined as eligible for 
appointment by the governing body in accordance with State law, 
including scope-of-practice laws.
     Revise paragraph (a)(2) to require that the medical staff 
must examine the credentials of ``all'' eligible candidates and then 
make recommendations on medical staff membership to the governing body, 
and require that a candidate who has been recommended by the medical 
staff and appointed by the governing body be subject to all medical 
staff bylaws, rules, and regulations, in addition to the requirements 
contained in Sec.  482.22.

Nursing Services (Sec.  482.23)

     Revise paragraph (c)(1)(i) to clarify that 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, ``hospital policies, and medical staff bylaws, 
rules, and regulations.''
     Revise paragraph (c)(3)(iii) to clarify that 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, including scope- 
of- practice laws, ``hospital policies, and medical staff bylaws, 
rules, and regulations.''
     Revise paragraphs (c)(6)(i)(A) and (c)(6)(ii)(A) to change 
``assure'' to ``ensure.''
     Revise paragraphs (c)(6)(i)(D) and (c)(6)(ii)(D) to 
clarify that the hospital must have policies and procedures in place to 
``address'' the security of the medication(s) for each patient and to 
document the administration of each medication.
     Revise paragraphs (c)(6)(i)(E) and (c)(6)(ii)(E) to 
provide that the hospital must document the administration of 
medication ``as reported by the patient (or the patient's caregiver/
support person where appropriate), in the patient's medical record.''

Medical Record Services (Sec.  482.24)

     Revise paragraphs (c)(2) and (c)(3)(iv) to remove the 
reference to Sec.  482.12(c) and to clarify that all orders, including 
verbal orders and standing orders, must be dated, timed, and 
authenticated promptly by the ordering practitioner or by another 
practitioner who is responsible for the care of the patient ``only if 
such a practitioner is acting in accordance with State law, including 
scope-of-practice laws, hospital policies, and medical staff bylaws, 
rules, and regulations.''
     Revise paragraphs (c)(3)(i) and (c)(3)(iii) by removing 
proposed language ``in consultation with.''

CAHs

     We have removed the definition for direct services at 
Sec.  485.602, we have removed the reference to ``direct services'' at 
Sec. Sec.  485.623(a) and 485.635(a)(3)(i).
     In Sec.  485.604(a), we revised the definition to provide 
that a clinical nurse specialist is a registered nurse and is licensed 
to practice nursing in the

[[Page 29066]]

State in which the clinical nurse specialist services are performed, 
``in accordance with State nurse licensing laws and regulations;'' and 
holds ``a master's or doctoral level'' degree in a defined clinical 
area of nursing from an accredited educational institution.

IV. 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). Responses to comments received for this section 
can be found below in the Regulatory Impacts section (V).
    According to CMS, there are about 4,900 hospitals (not including 
CAHs) that are certified by Medicare. 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'' (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 compensate for overhead and fringe 
benefits.

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

    Section 482.13(g) removes 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 includes 
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 Sec.  
482.13(g)(2)(i) and (ii). We noted 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 rule 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)). Section 482.23(b)(4) allows 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 Sec.  
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 rule 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 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 this 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

[[Page 29067]]

current regulations and would adjust for any burden reductions 
resulting from this provision once the current rule 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)). In this 
final rule, we are eliminating 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 rule 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)

    In this final rule, we are removing Sec.  482.92(a) entirely. The 
elimination of this section removes 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 Sec.  
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 rule is finalized. For a 
more detailed discussion of estimated burden and cost savings, please 
see the Regulatory Impact Analysis section of this rule.

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 final 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 final 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 conducted a retrospective review of the CoPs it imposes 
on hospitals to remove or revise obsolete, unnecessary, or burdensome 
provisions. The goal of the retrospective review was to identify 
opportunities to reduce system costs by removing obsolete or burdensome 
requirements while maintaining patient care and outcomes.
    CMS has not reviewed the entire set of CoPs for Hospitals in many 
years. These requirements have grown over time and, while often 
revised, have not been subject to a complete review. CMS staffs as well 
as CMS stakeholders, including TJC, the American Medical Association, 
the AHA, and many others, have identified problematic requirements over 
the years. Accordingly, we decided to conduct a retrospective review of 
the CoPs 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. Based on our analysis, we decided to 
pursue those regulatory revisions that would reflect the substantial 
advances made in healthcare delivery and that would benefit hospitals 
and CAHs through cost savings.
    We received hundreds of substantive comments supporting our choice 
of provisions for reform, the specific reforms we proposed, and the 
general conclusions we had reached as to likely importance or magnitude 
of potential savings. Public comments and corresponding responses 
regarding the Collection of Information Requirements and the Regulatory 
Impacts section can be found below:
    Comment: We received numerous comments regarding the paperwork or 
information collection requirement (ICR) section and the regulatory 
impact section from health care institutions and their national 
organizations, health care

[[Page 29068]]

providers and their national organizations, health care advocacy 
organizations, as well as others. Most of these commenters were 
supportive of our efforts to reduce burden from the hospital CoPs, 
especially those that did not contribute to quality patient care, and 
our estimates of the resulting savings. Many commenters, especially 
health care providers stated that removing these burdensome provisions 
would actually contribute to quality of care for patients, allow them 
more time for direct patient care, and to better utilize their 
resources.
    Response: We would like to thank the commenters for their support 
of our efforts to reduce the burden from the hospital CoPs.
    Comment: We received a few comments that questioned our estimate of 
882,000 occurrences of patients who died while either in, or within 24 
hours of being removed from, soft, wrist only restraints. One commenter 
noted that we did not account for the time that would be required to 
perform the log entries.
    Response: We agree with the commenters. Since publication of the 
proposed rule, we have reviewed some new data and agree that the 
estimate of 882,000 occurrences is likely overstated. We have revised 
our estimate below. We did not account for the time it would take to 
complete a log entry in the proposed rule. We believe that hospitals 
would likely choose the most efficient manner in which to keep this 
log. For example, they may have a nurse complete these entries as a 
group or develop a process for transferring the information 
electronically to a log. We continue to believe that removing the 
requirement to report these deaths to CMS would result in the savings 
we estimated in the proposed rule, of approximately 15 minutes for each 
entry.
    Comment: We received a few comments that questioned our estimate of 
$330 million in savings from the proposed revisions in Sec.  482.22. 
Commenters indicated that they wanted further clarification, that they 
believed the estimate was in error, and questioned using the difference 
between a physician and non-physician's salary.
    Response: We disagree with the commenters. In fact, we believe that 
the savings might be much greater. Our detailed estimate is located in 
the regulatory impact section (below). As we noted, we only estimated 
the savings for inpatient hospital stays. We did not estimate the 
savings for the approximately 620,000 annual outpatient visits. 
Therefore, we have not modified our estimate.
    Very few of these comments provided any criticism of, and no 
comments offered technical information to improve, our estimates of 
potential savings. Accordingly, we have not changed our estimates of 
potential and likely savings. We plan to evaluate cost savings and 
other potential impacts in the future, including changes that might 
increase or decrease patient safety or health, based on actual changes 
implemented by hospitals and CAHs. It is important to understand that 
our estimates are necessarily uncertain because they depend largely on 
changes that hospitals and their medical staffs could decide to adopt 
or not adopt on a case-by-case basis. Some estimates also depend upon 
the future decisions by States to change their laws and regulations 
covering the scope of practice of non-physician practitioners.
    Comment: A number of commenters noted that the ability of hospitals 
and CAHs to implement these reforms would depend upon our revising the 
current interpretative guidelines for the hospital and CAH CoPs.
    Response: As we have discussed elsewhere in this rule, we will be 
issuing guidance on how hospitals and CAHs can implement the changes in 
this final rule shortly.
3. Summary of Impacts
    These reductions in process and procedure requirements detailed in 
this final rule may allow hospitals and CAHs to redirect staff 
resources to areas of higher priority that they view as producing 
greater benefit to patients. They could also enhance hospitals' ability 
to flexibly deploy resources and 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
          [2012 Dollars; entries rounded to nearest $100K if under $50M and to nearest $10M if higher]
----------------------------------------------------------------------------------------------------------------
                                                                                      Annual         Five year
                         Regulatory area                              Section      savings ($K)    savings  ($K)
----------------------------------------------------------------------------------------------------------------
Patient's Rights--Death Notice Soft Restraints..................         482.13           $5,100         $25,500
Medical Staff...................................................         482.22          330,000       1,650,000
Nursing Services--Care Plan.....................................         482.23          110,000         550,000
Medical Record Services--Authentication.........................         482.24           80,000         400,000
Medical Record Services--Standing Orders........................         482.24           90,000         450,000
Infection Control--eliminate log................................         482.42            6,600          33,000
Outpatient Services.............................................         482.54          300,000       1,500,000
Transplant Organ Recovery.......................................         482.92              200           1,000
CAH Provision of Services.......................................         485.635          15,800          79,000
                                                                 -----------------------------------------------
    Total.......................................................  ..............         937,700       4,688,500
----------------------------------------------------------------------------------------------------------------

    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 are modifying or 
deleting, we

[[Page 29069]]

are not aware of any information suggesting that these changes would 
create consequential risks for patients. In other words, we do not 
believe that any eliminated requirement in this final rule has saved 
lives in recent decades. In public comments, several commenters raised 
important questions regarding patient safety. We reviewed all of those 
comments with great care; however, in our review of these comments we 
could not identity a single comment that provided any empirical or 
scientific evidence, or even plausible arguments, that any proposed 
reform threatened patient safety. The mere possibility of harm, 
unsupported by evidence, does not justify retention of regulatory 
provisions that are based on mere supposition or hypothetical 
arguments. Under the standards of EO 12866 and EO 13563, a regulatory 
requirement must be justified by a showing of need. No comments we 
received demonstrated any need to retain the particular provisions we 
proposed to eliminate or reform.
4. Anticipated Impacts
    There are about 4,900 hospitals and 1,200 CAHs that are certified 
by Medicare. According to CASPER (February 1, 2012), there are 6,180 
hospitals. However, that number includes religious non-medical health 
care institutions (RNHCIs), which are not included in this rule, and 
critical access hospitals (CAHs), which are not included in the 
hospital provisions. In addition, according to CMS, there are about 107 
CAHs with distinct part units (DPUs) that must comply with the hospital 
CoPs. Therefore, we have analyzed the hospital provision for 4,900 
hospitals (6,180 total hospitals--18 RNHCIs--1,330 CAHs + 107 CAHs with 
DPUs = 4,939 or about 4,900 hospitals). For the CAHs, we analyzed the 
burden for 1,200 CAHs (1,330 CAHs -107 CAHs with DPUs that are analyzed 
with the hospitals = 1,223 or about 1,200 CAHs). Thus, in the final 
rule, we used these figures to estimate the potential impacts of this 
rule. In addition, we used 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/). We 
received no comments suggesting a change in these hourly wage 
assumptions.
    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 normally necessary 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)
    In this final rule, we are removing 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 for patients who died within 24 hours of having been removed 
from these types of restraints is also removed.
    In the proposed rule, we estimated 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. In addition, we also received comments questioning the estimate of 
882,000 occurrences. We conducted further research and have decided 
that our estimate in the proposed rule was overstated. Therefore, we 
have revised our savings estimate below.
    In addition, the assumption in the 2006 final rule was that 
administrative support personnel would carry out these functions. 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.
    According to the United States Agency for Healthcare Research and 
Quality (AHRQ), there were 757,841, or about 758,000, in-hospital 
deaths in 2009 (http://hcupnet.ahrq.gov/HCUpnet.jsp accessed February 
10, 2010). There are many reasons for a patient to be physically 
restrained. According to Evans and FitzGerald, two of the most often 
cited reasons for restraining patients were treatment-related and for 
safety reasons (Evans, D. and FitzGerald, M, Reasons for physically 
restraining patient and residents: a systematic review and content 
analysis, International Journal of Nursing Studies 39 (2002), pp. 735-
743). The treatment-related reasons include preventing patients from 
disturbing medical devices, such as endotracheal tubes, intravenous 
lines (IVs), nasogastric or feeding tubes, urinary catheters, wounds, 
dressings, and sutures (Evans and FitzGerald, p. 738). Patients might 
also be restrained for their own safety, such as when patients have 
impaired judgment or might harm themselves. We believe that many of the 
patients who die in the hospital are those who were seriously ill or 
injured and whose treatment likely involved medically necessary devices 
(such as endotracheal tubes and respirators due to post-operative 
respiratory failure) or those who may have suffered from impaired 
cognition and judgment due to their conditions. Thus, we believe that 
many of these patients may have been restrained at the time of, or 
within 24 hours of, their deaths so that medically necessary treatments 
could be carried out in the most safe and effective manner. Thus, we 
estimate that 60 percent of the 758,000 in-hospital deaths, or 454,800 
deaths, would have been reported to CMS.
    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. We are also basing this timesaving estimate on our 
experiences with hospitals as well as feedback from stakeholders that 
indicated that this estimate was reasonable. Therefore, we estimate 
that this reduction in burden would reduce each hospital's burden hours 
by about 23 hours (454,800 occurrences x .25 hours / 4,900 = 23.20 or 
about 23 hours) each year valued at $45 for each hour for an average 
annual savings of $1,035 (23 hours x $45 hourly wage for a nurse = 
$1,035). Thus, we estimate that for all 4,900 hospitals this would 
result in a savings of about $5,116,500 (454,800 occurrences x $45 x 
.25 hours = $5,116,500 estimated savings).
Medical Staff (Sec.  482.22)
    Our changes and clarifications regarding medical staff and 
privileging allow hospitals to substitute and rearrange actual delivery 
of care. In particular, use of Advanced Practice Nurse Practitioners 
(APRNs) and

[[Page 29070]]

Physician Assistants (PAs) in lieu of higher-paid physicians could 
provide immediate savings to hospitals. While we have no precise basis 
for calculating potential savings, we feel confident that our estimates 
reflect a reasonable approach to hospital cost savings. However, much 
will depend on the future staffing and management decisions that 
individual hospitals make. For example, the savings that we believe 
that hospitals will realize from the changes to the Medical staff CoP 
will depend on the extent to which hospitals take advantage of the 
regulatory flexibility that the new requirements afford. Those 
hospitals that view these changes as a means to be more inclusive of 
non-physician practitioners on their medical staffs would most likely 
reap the most benefits.
    With that said, we also believe that an interdisciplinary team 
approach to patient care is the best model for hospital patients. 
Within this model, non-physician practitioners have proven themselves 
capable of handling many common patient complaints, initial patient 
work-up and follow-up, patient education and counseling, and the 
specific aspects of patient care for which they have been educated and 
trained. Physicians, as leaders of these teams due to their more 
extensive training and expertise, are then able to more fully turn 
their attention to more complicated patient problems. In this way, non-
physician medical staff members allow physicians to more efficiently 
and effectively manage their time so that these physician leaders can 
focus on more medically complex patients. It is within this context of 
efficient and effective care delivery by physicians and non-physician 
practitioners working collaboratively that we have based our estimates. 
For purposes of this analysis, we have reached an estimate of $330 
million in savings using the following assumptions, which are based on 
our experience with hospitals:
     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 structure their medical staffs in this manner;
     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 non-physician 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/
non-physician practitioner time x $71 per hourly wage difference x 33 
percent of physician time with patients covered by non-physician 
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 these 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 received several comments criticizing this lack of precision in 
these estimates. One of these suggested additional consultation with 
stakeholders. We agree with those commenters that better estimates 
would be desirable. However, no commenters provided any information 
showing that there would be costs not accounted for in these estimates 
(for example, reductions in patient safety), or provided any 
information showing that these estimates were either too low or too 
high. Since these estimates depend overwhelmingly on future State 
decisions regarding non-physician practitioner practice limitations, 
and on the independent decisions of hospital governing boards and 
medical staffs, we have no basis for a revision in this final rule. We 
point out, however, that our initial savings estimates were quite 
conservative when viewed against the potential ability of medical 
staffs to economize by delegation to non-physician practitioners acting 
within the scope of the licenses already granted by many States.
    The most obvious example of this potential ability to economize by 
delegation would be the surgeon who uses the services of available 
hospital APRNs and PAs to see and provide post-operative care and 
management of his or her patients, freeing the surgeon to focus on 
procedures and surgeries in the operating room. The surgeon still leads 
the team, but this model allows for both the surgeon and the APRN or PA 
to practice to the full extent of their training and experience and to 
effectively manage their time regarding patient care, ultimately 
benefitting each patient in the process. Some hospitals have already 
realized that having a dedicated APRN/PA service available to 
physicians can reduce overall costs by allowing for the more effective 
management and care of most patients during their hospital stay, from 
admission through discharge. In listening to stakeholders, we realized 
that the revisions to the Medical staff CoP that we have finalized here 
are necessary to ensure that all hospitals have the opportunities for 
potential savings and improved patient care that we believe are likely. 
With some significant exceptions discussed earlier in this preamble, 
mainly focused on anesthesiology or on medical governance received from 
physicians, we received overwhelming support for these proposals. All 
major non-physician stakeholder groups supported our reforms and the 
likely magnitude of savings.
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. In this final rule, we are allowing 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

[[Page 29071]]

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, this would result in a reduction of 
2,400,000 burden hours valued at $45 per hour for a savings of 
$108,000,000. The comments we received by nursing groups and other 
expert reviewers strongly supported our policy change and these overall 
estimates, though without providing any empirical support for the 
precise savings we estimated.
Medical Record Services--Authentication and Standing Orders (Sec.  
482.24)
    In this final rule, we are revising 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 also are making 
permanent the temporary provision (5-year sunset provision which 
expired in 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 adding 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 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. As discussed in the Information 
Collection section, comments overwhelmingly supported this reform and 
did not suggest specific changes in our estimates.
Outpatient Services (Sec.  482.54)
    Allowing one or more individuals to be responsible for the 
supervision of outpatient services would permit large savings in this 
final rule. Under the existing CoP, 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 
that potential. Based upon our experience with hospitals, we estimate 
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 regardless of how 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. We received very few 
comments on this reform, but all of these supported the reform and 
agreed it would produce substantial savings.
Transplant Organ Recovery (Sec.  482.92)
    We are removing the current blood typing requirement entirely. The 
elimination of this section removes 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 are deleting 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 this finalized requirement, the OPO 
performs a verification before organ recovery and the transplant center 
surgeon performs a verification before the organ is transplanted. We 
are eliminating 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. 
Eliminating

[[Page 29072]]

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). Surgeons 
working for their own transplant centers conduct most organ recoveries 
for heart and lung transplants. 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. Based on our experience with transplant centers, we estimate 
that surgeons who are working for the transplant centers conduct 25 
percent of kidney, liver and pancreas organ recoveries. 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.
    Several commenters pointed out that we would need to change our IG 
to surveyors to assure these savings. We agree, and will make the 
necessary changes.
Infection Control Log (Sec.  484.42)
    We are eliminating a requirement for keeping a dedicated log of 
incidents related to infections and communicable diseases, and instead 
allowing hospitals flexibility in their approach to the tracking and 
surveillance of infections. We believe the changes we are finalizing 
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 (that is., 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. Again, 
we received no comments suggesting that these savings could not be 
realized.
CAH Provision of Services (Sec.  485.635)
    Our 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. This is an area where our savings may well be 
underestimated, based on the tenor of the comments we received. We did 
not, however, obtain suggestions for specific changes.
5. Alternatives Considered
    From within the entire body of CoPs, 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 final rule.
    For each requirement that we have deleted or modified, there were a 
number of possible options, including making no change, making the 
change we proposed, and in some but not all cases making some in-
between change. There was 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.
    Throughout the preamble to this final rule, we have identified ways 
to improve, avoid problems, or clarify the proposed reforms. Many of 
these improvements arose directly from public comments. While some of 
those changes are vital to realizing the reforms we proposed, most of 
the final rule changes required no substantial changes to our estimates 
of the potential reductions in regulatory burden.
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 eliminated 
requirement contributed in any consequential way to patient safety. 
Thus, we are confident that the final rule yields net benefits. In this 
analysis, we provided some illustrative estimates to suggest the 
potential savings these reforms could achieve under certain 
assumptions. We appreciate that those assumptions are simplified, and 
that actual results could be substantially higher or lower. We have no 
basis for estimating the range of uncertainty with any precision. 
Moreover, in the set of calculations for each reform one assumption 
might be too high and another too low, with these offsetting effects 
leading to a similar overall saving even though each component of the 
calculation could be substantially higher or lower. Therefore, no one 
set of range estimates could capture the many uncertainties involved. 
We plan to evaluate these reforms over time, and welcome independent 
external evaluations of their effects by professional societies, 
individual hospitals, hospital associations, academics, and others. We 
are particularly interested in evidence as to actual savings in time 
and effort realized as hospitals implement the increased flexibility 
provided by 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.

[[Page 29073]]

                  Table 2--Accounting Statement: Classification of Estimated Costs and Savings
                                                 [$ In millions]
----------------------------------------------------------------------------------------------------------------
                                                                                       Units
                                                      Primary    -----------------------------------------------
                    Category                         estimate                                         Period
                                                                   Year dollars    Discount rate      covered
----------------------------------------------------------------------------------------------------------------
Benefits........................................                               None
----------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized reductions in Costs....           -$940            2012              7%         2012-16
                                                           -$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. In addition, 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 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 CoPs. 
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 final rule would not have a significant economic impact on a 
substantial number of small entities, and that a Final 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 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 $139 million. This final 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 final rule 
would not significantly affect the rights, roles, or responsibilities 
of the States. This final 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 
received several comments on the Federalism analysis in the proposed 
rule and respond as follows. The problem facing States considering 
reforms in scope of practice and other laws was that our previous rules 
would in many areas have rendered useless State reforms, since we 
dictated stringent limits on non-physician roles. By removing these 
unnecessary limits, we are enabling States to consider such reforms 
without Federal constraints that, while not legally preemptive, in 
practical effect would have nullified potential State reforms. We 
believe that some States are therefore likely to legislate reforms that 
would take advantage of this increased flexibility to reduce health 
care costs by allowing non-physician practitioners to utilize the full 
scope of their training and expertise. We support this increased 
flexibility for States to make reforms that they determine are 
professionally appropriate and reduce health care costs while 
protecting or improving patient care.

[[Page 29074]]

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 amends 42 CFR chapter IV as set forth below:

PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS

0
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

0
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. The governing body (or 
the persons legally responsible for the conduct of the hospital and 
carrying out the functions specified in this part that pertain to the 
governing body) must include a member, or members, of the hospital's 
medical staff.
* * * * *

0
3. Section 482.13 is amended by --
0
a. Revising paragraphs (g)(1) through (3).
0
b. Adding paragraph (g)(4).
    The revisions and addition 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 record in an internal log or other 
system, the following information:
    (i) Any death that occurs while a patient is in such restraints.
    (ii) Any death that occurs within 24 hours after a patient has been 
removed from such restraints.
    (3) The staff must document in the patient's medical record the 
date and time the death was:
    (i) Reported to CMS for deaths described in paragraph (g)(1) of 
this section; or
    (ii) Recorded in the internal log or other system for deaths 
described in paragraph (g)(2) of this section.
    (4) For deaths described in paragraph (g)(2) of this section, 
entries into the internal 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, name of attending physician or other licensed 
independent practitioner who is responsible for the care of the patient 
as specified under Sec.  482.12(c), medical record number, and primary 
diagnosis(es).
    (iii) The information must be made available in either written or 
electronic form to CMS immediately upon request.
* * * * *

Subpart C--Basic Hospital Functions

0
4. Section 482.22 is amended by revising paragraphs (a) introductory 
text, (a)(2), and (b)(3) to read as follows:

Sec.  482.22  Condition of participation: Medical staff.

* * * * *
    (a) Standard: Eligibility and process for appointment to medical 
staff. The medical staff must include doctors of medicine or 
osteopathy. In accordance with State law, including scope-of-practice 
laws, the medical staff may also include other categories of non-
physician practitioners determined as eligible for appointment by the 
governing body.
* * * * *
    (2) The medical staff must examine the credentials of all eligible 
candidates for medical staff membership and make recommendations to the 
governing body on the appointment of these candidates in accordance 
with State law, including scope-of-practice laws, and the medical staff 
bylaws, rules, and regulations. A candidate who has been recommended by 
the medical staff and who has been appointed by the governing body is 
subject to all medical staff bylaws, rules, and regulations, in 
addition to the requirements contained in this section.
* * * * *
    (b) * * *
    (3) The responsibility for organization and conduct of the medical 
staff must be assigned only to one of the following:
    (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.
    (iii) A doctor of podiatric medicine, when permitted by State law 
of the State in which the hospital is located.
* * * * *

0
5. Section 482.23 is amended by revising paragraphs (b)(4) and (c) to 
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

[[Page 29075]]

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, hospital policies, and medical staff 
bylaws, rules, and regulations.
    (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, including scope-
of-practice laws, hospital policies, and medical staff bylaws, rules, 
and regulations.
    (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) Ensure 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) Address the security of the medication(s) for each patient.
    (E) Document the administration of each medication, as reported by 
the patient (or the patient's caregiver/support person where 
appropriate), 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) Ensure 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) Address the security of the medication(s) for each patient.
    (E) Document the administration of each medication, as reported by 
the patient (or the patient's caregiver/support person where 
appropriate), in the patient's medical record.

0
6. Section 482.24 is amended by--
0
a. Removing paragraphs (c)(1)(i) through (iii).
0
b. Redesignating (c)(2) as (c)(4).
0
c. Adding a new paragraphs (c)(2) and (3).
    The 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 by another 
practitioner who is responsible for the care of the patient only if 
such a practitioner is acting in accordance with State law, including 
scope-of-practice laws, hospital policies, and medical staff bylaws, 
rules, and regulations.
    (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 and 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 and the hospital's 
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 by another practitioner responsible for the care of the 
patient only if such a practitioner is acting in accordance with State 
law, including scope-of-practice laws, hospital policies, and medical 
staff bylaws, rules, and regulations.
* * * * *

0
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.
* * * * *

0
8. Section 482.42 is amended by revising paragraphs (a) introductory 
text 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,

[[Page 29076]]

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

0
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]

0
10. Section 482.92 is amended by--
0
a. Removing paragraph (a).
0
b. Redesignating paragraphs (b) and (c) as (a) and (b) respectively.

PART 485--CONDITIONS OF PARTICIPATION SPECIALIZED PROVIDERS

0
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]

0
12. Section 485.602 is removed.

0
13. In Sec.  485.604, paragraph (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 
in accordance with State nurse licensing laws and regulations; and
    (2) Holds a master's or doctoral level degree in a defined clinical 
area of nursing from an accredited educational institution.
* * * * *

0
14. In Sec.  485.623, paragraph (a) is revised to read as follows:

Sec.  485.623  Condition of participation: Physical plant and 
environment.

    (a) Standard: Construction. The CAH is constructed, arranged, and 
maintained to ensure access to and safety of patients, and provides 
adequate space for the provision of services.
* * * * *

0
15. In Sec.  485.635, paragraphs (a)(3)(i) and (b) are revised to read 
as follows:

Sec.  485.635  Condition of participation: Provision of services.

    (a) * * *
    (3) * * *
    (i) A description of the services the CAH furnishes, including 
those furnished through agreement or arrangement.
* * * * *
    (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 
the following:
    (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.
    (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.
* * * * *

0
16. 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: March 19, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
    Approved: April 2, 2012.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2012-11548 Filed 5-10-12; 9:15 am]
BILLING CODE 4120-01-P
```