Federal Register /Vol. 75, No. 157
/Monday, August 16, 2010 /Rules and
Regulations 50405
IX. Medicare Hospital Conditions of
Participation Affecting Rehabilitation
Services and Respiratory Care Services
Recently, CMS received several public
requests for clarification of the Medicare
conditions of participation (CoPs) for
hospitals relating to rehabilitation
services at § 482.56 and respiratory care
services at § 482.57. The questions
concerning these conditions have been
in the context of apparent
inconsistencies between the two CoPs
themselves, and between the two CoPs
and many State laws, regarding which
practitioners are allowed to order
rehabilitation and respiratory care
services in the hospital setting.
Many States, under their scope-of practice
laws and other regulations,
allow only specific qualified, licensed
practitioners (including physicians,
nurse practitioners (NPs), and physician
assistants (PAs)) to order rehabilitation
services and respiratory care services, in
addition to other common hospital
services such as dietary and social work
services. However, the current standard
at § 482.56(b) (Delivery of services)
requires only that hospital rehabilitation
services (for example, physical therapy,
occupational therapy, audiology, and
speech-pathology services) be ordered
by ‘‘practitioners who are authorized by
the medical staff to order the services.’’
We believe that this requirement is too
open to interpretation and does not
explicitly acknowledge various State
laws that limit the ordering of hospital
services (including diagnostic tests,
drugs and biologicals, and inpatient
treatment modalities) to specific
qualified, licensed practitioners who are
responsible for the care of the patient.
By contrast, the current requirement
for respiratory care services at
§ 482.57(b)(3), which explicitly states
that these services ‘‘must be provided
only on, and in accordance with, the
orders of a doctor of medicine or
osteopathy,’’ is too narrow. While
doctors of medicine or doctors of
osteopathy have the option of delegating
this task to NPs and PAs, this delegation
requires physicians to countersign all
orders by NPs or PAs for respiratory
care services. We have not found any
evidence that indicates that the ordering
of respiratory care services should be
kept to a different, and possibly higher,
standard than rehabilitation and other
hospital services. Nor have we found
any documented studies indicating that
qualified, licensed practitioners such as
NPs and PAs should be restricted from
ordering these necessary services for
their patients. Further, we believe that
the process of physician
countersignature of orders written by
qualified, licensed NPs and PAs,
specifically for common hospital
services such as rehabilitation and
respiratory care services, is burdensome
to practitioners (physicians as well as
NPs and PAs) and the hospitals that
they serve. In addition, we believe that
this process also runs counter to what
many States have already decided for
NPs and PAs in their individual State
regulations and scope-of-practice laws.
As a result of our analysis of the
issues surrounding conflict of the
Medicare CoPs with State laws, and
conflict of the Medicare CoPs with each
other, in the FY 2011 IPPS/LTCH PPS
proposed rule (75 FR 24050), we
proposed several revisions to the
existing regulations. We proposed to
revise § 482.56 to clarify the types of
practitioners that are allowed to order
rehabilitation services. Further, we
proposed to limit those types of
individuals to qualified, licensed
practitioners who are responsible for the
care of the patient and who are acting
within the scope of practice under State
law. We also proposed that these
practitioners would need to be
authorized to order rehabilitation
services by the hospital’s medical staff,
in accordance with both hospital
policies and procedures and State laws.
In addition, we proposed changes to
the existing requirements for the
ordering of respiratory care services at
§ 482.57. Existing requirements only
allow for services to be provided on the
orders of a doctor of medicine or
osteopathy. As stated above, we recently
received several public requests
(including requests from various
hospitals as well as from The Joint
Commission) for clarification of this
requirement in the context of what is
currently allowed under many State
laws. Many States, under their scopeofpractice
laws and other regulations,
allow qualified, licensed practitioners
(including NPs and PAs) to order
respiratory care services. We proposed
to revise the existing requirements at
§ 482.57 to allow these practitioners, in
addition to physicians as currently
allowed, to order these services as long
as such privileges are authorized by the
medical staff and are in accordance with
both hospital policies and procedures
and State laws. As is required under the
CoPs for all patient orders, the ordering
practitioner must also be an individual
who is responsible for the care of the
patient.
In both of the CoPs for rehabilitation
services and respiratory care services,
we also proposed that all orders for
these services be documented in
accordance with the requirements at
§ 482.24, Medical records.
Comment: The majority of
commenters supported the proposed
changes for the CoPs for rehabilitation
services and respiratory care services.
Some of the commenters commended
CMS for proposing changes that they
believed accurately reflected current
standards of practice. Many of the
commenters supported the proposed
changes focused exclusively on the
proposed requirements for respiratory
care services.
Response: We appreciate the
commenters’ support for the proposed
changes. We believe that many of the
commenters focused exclusively on the
proposed revisions to the respiratory
care services CoP because these
revisions would allow for qualified,
licensed practitioners, such as NPs and
PAs, to order respiratory care services in
addition to physicians, that is, doctors
of medicine and doctors of osteopathy,
as is currently allowed under the
requirements. While we believe that the
proposed change to the rehabilitation
services CoP is more of a clarification of
which types of practitioners (as
delineated by State law, hospital policy,
and medical staff authorization) would
be allowed to order such services, we
believe that the proposed revision to the
respiratory care services CoP represents
a regulatory recognition of the
qualifications that nonphysician
practitioners, such as NPs and PAs,
bring to hospital patient care and that
this recognition accounts for many of
the commenters focusing exclusively on
the change to this CoP.
Comment: Several commenters
questioned what they saw as an
exclusion from the proposed rule of
other types of advanced practice
registered nurses (APRNs) (for example,
clinical nurse specialists (CNSs),
certified registered nurse anesthetists
(CRNAs), and certified nurse midwives
(CNMs)), as well as rehabilitation
professionals such as physical therapists
(PTs) and speech-language pathologists
(SLPs).
Response: Our intention was not to
exclude other types of nonphysician
practitioners such as APRNs, PTs, SLPs,
or other types of rehabilitation
professionals from the proposed rule
provisions. We recognize the important
role that these practitioners and
professionals play in the delivery of
quality care to hospital patients. We
point out that the proposed regulatory
language does not specifically mention
any ‘‘type ‘‘of practitioner, including
NPs and PAs. Instead, the proposed
revisions to both CoPs would require
that services be provided only under the
orders of a qualified, licensed
practitioner, responsible for the care of
the patient, acting within his or her
scope of practice, and authorized by the
medical staff to order the services in
accordance with hospital policies and
procedures and all State laws. Although
NPs and PAs were the only examples of
practitioner types that we used in our
discussion of the proposed changes in
the preamble of the proposed rule, our
intention, as reflected in the proposed
regulation text, is to include those
qualified, licensed practitioners who
meet the parameters of the proposed
requirements discussed above.
Comment: A few commenters took
exception to our discussion in the
preamble of conflict of interest and
coordination of care issues in the
context of rehabilitation professionals
(such as PTs and SLPs) who might order
their own rehabilitation services for a
hospital patient without the knowledge
of the attending physician or of the
practitioner responsible for the overall
care of the patient (such as APRNs and
PAs). They questioned ‘‘why CMS
would conclude that these problems
[conflict of interest and coordination of
care] would occur in the outpatient
hospital setting when patients receive
rehabilitation services,’’ and asked that
the final rule not adopt language that
would exclude rehabilitation
professionals from acting within their
individual State’s scope of practice. One
commenter suggested that language
distinguishing between hospital
inpatient and outpatient rehabilitation
services be added to the proposed
requirement at § 482.56(b).
Response: The proposed requirements
would apply to both inpatient and
outpatient hospital services. Because the
language allows for the ordering of
rehabilitation services based on (and in
deference to) State laws and scope-of
practice
acts, medical staff
authorization, and hospital policies and
procedures, we firmly believe that
nothing in our proposed requirement
would preclude a hospital rehabilitation
professional from acting within the
scope of practice under State law. For
this reason also, we disagree that the
requirement needs to make distinctions
between inpatients and outpatients.
Comment: A few commenters
correctly pointed out that the hospital
CoPs apply to both inpatient and
outpatient services. With regard to this
application of the hospital CoPs to the
outpatient services of a hospital, they
commented that the proposed changes
would be in direct conflict with both
CMS payment policy, which they state
allows for rehabilitation professionals to
order their own services for hospital
outpatients without physician referral,
and the regulations of some States,
which they state allow for ‘‘direct
access’’ to rehabilitation services for
hospital outpatients.
Response: As we have previously
stated, we do not believe that the
proposed changes would conflict with
either CMS payment policy or State
regulations. In fact, we have drafted the
regulatory text in a way that would not
only defer to hospital policy and
medical staff authority in granting
ordering privileges for these services to
qualified, licensed practitioners, but
also to State laws and scope-of-practice
acts. We believe that these proposed
regulations would give hospitals and
their medical staffs as much flexibility
in determining which types of
practitioners could order these services
as they would choose to exercise within
the constraints of their own State laws
and regulations.
Comment: One commenter noted that
as many as 35 States have some form of
regulatory language that states, in effect,
that hospital respiratory care services
orders must be ‘‘written by a licensed
physician only.’’
Response: As stated in our previous
response, the proposed regulations are
written in such a way as to avoid the
preemption of State law and regulation.
We expect hospitals to apply the laws
of their respective States to their policy
regarding which types of practitioners
would be allowed to order respiratory
care services. For those States that allow
APRNs and PAs to order respiratory
care services without the need for a
physician co-signature, we expect
hospitals in those States to determine
which types of practitioners would be
authorized by the medical staff to write
these orders in accordance with State
law. We also expect that practitioners
will act within the limitations of their
individual State laws and hospitals’
policies.
Comment: One commenter requested
that changes similar to the ones
proposed be made to other hospital
CoPs, such as nuclear medicine and
dietary services, and their interpretive
guidelines, and also specifically
proposed changes to § 482.25(b)(6) to
require that ‘‘drug administration errors,
adverse drug reactions, and
incompatibilities be immediately
reported to the ordering practitioner.’’ In
addition, the commenter recommended
that the interpretative guidelines issued
for § 482.24(c)(1) be revised.
Response: While we appreciate the
input from the commenter regarding the
other hospital CoPs and the
interpretative guidelines, changes to
other CoPs are outside the scope of this
final rule. Any revisions to the
interpretative guidelines are outside the
purview of the rulemaking process.
Comment: A few commenters, in
addition to voicing full support for the
proposed changes, encouraged CMS to
revise the CoPs and interpretative
guidelines regarding the administration
of propofol (a rapidly acting, short
duration, intravenous hypnotic
anesthetic induction agent used as a
general anesthetic or as an adjunct to
anesthesia) by an anesthesiologist or
CRNA in the context of recognition of
State laws addressing this issue.
Response: As we stated in our
previous response, while we appreciate
the input from commenters, we cannot
address it at this time because the issues
are outside the scope of this rule.
Furthermore, any revision of the
interpretative guidelines would be
outside the purview of the rulemaking
process.
After consideration of the public
comments we received, we are adopting
as final without modification, our
proposals to revise § 482.56 and
§ 482.57 to clarify the types of
practitioners who are allowed to order
rehabilitation services and respiratory
care services, respectively in accordance
with both hospital policies and
procedures and State laws; and to
provide that all orders for these services
be documented in accordance with
existing requirements at § 482.24.