[Federal Register Volume 77, Number 95 (Wednesday, May 16, 2012)]
[Rules and Regulations]
[Pages 29034-29076]
From the Federal Register Online via the Government Publishing 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
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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................
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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