[Federal Register Volume 60, Number 143 (Wednesday, July 26, 1995)]
[Rules and Regulations]
[Pages 38266-38272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-18282]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
42 CFR Part 424
[BPD-709-FC]
RIN 0938-AF01
Medicare Program; Allowing Certifications and Recertification by
Nurse Practitioners and Clinical Nurse Specialists for Certain Services
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Final rule with comment period.
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SUMMARY: This final rule with comment period authorizes nurse
practitioners and clinical nurse specialists, working in collaboration
with a physician, to certify and recertify that extended care services
are needed or continue to be needed. In addition, it sets forth the
qualification requirements that a nurse practitioner or clinical nurse
specialist must meet in order to sign certification or recertification
statements. This final rule is necessary to implement section 6028 of
the Omnibus Budget Reconciliation Act of 1989.
DATES: Effective Date: These regulations are effective on August 25,
1995.
Comment Date: Comments regarding the qualification requirements
will be considered if we receive them at the appropriate address, as
provided below, no later than 5 p.m. on September 25, 1995.
ADDRESSES: Mail written comments (1 original and 3 copies) to the
following address: Health Care Financing Administration, Department of
Health and Human Services, Attention: BPD-709-FC, P.O. Box 7517,
Baltimore, MD 21207.
If you prefer, you may deliver your written comments (1 original
and 3 copies) to one of the following addresses:
Room 309-G, Hubert H. Humphrey Building, 200 Independence Avenue SW.,
Washington, DC 20201, or
Room 132, East High Rise Building, 6325 Security Boulevard, Baltimore,
MD 21207.
Because of staffing and resource limitations, we cannot accept
comments by facsimile (FAX) transmission. In commenting, please refer
to file code BPD-709-FC. Comments received timely will be available for
public inspection as they are received, generally beginning
approximately 3 weeks after publication of a document, in Room 309-G of
the Department's offices at 200 Independence Avenue SW., Washington,
DC, on Monday through Friday of each week from 8:30 a.m. to 5 p.m.
(phone: (202) 690-7890).
FOR FURTHER INFORMATION CONTACT: Jim Kenton, (410) 966-4607.
SUPPLEMENTARY INFORMATION:
I. Background
Section 1814(a) of the Social Security Act (the Act) requires
specific certifications in order for Medicare payments to be made for
certain services. Before the enactment of the Omnibus Budget
Reconciliation Act of 1989 (OBRA '89) (Pub. L. 101-239), section
1814(a)(2) of the Act required that, in the case of post-hospital
extended care services, a physician certify that the services are or
were required to be given because the individual needs or needed, on a
daily basis, skilled nursing care (provided directly by or requiring
the supervision of skilled nursing personnel) or other skilled
rehabilitation services that, as a practical matter, can only be
provided in a skilled nursing facility (SNF) on an inpatient basis.
The physician certification requirements were included in the law
to ensure that patients require a level of care that is covered by the
Medicare program and because the physician is a key figure in
determining utilization of health services.
OBRA '89 was enacted on December 19, 1989. Section 6028 of OBRA '89
amended section 1814(a)(2) of the Act to allow, in the case of extended
care services, a nurse practitioner or clinical nurse specialist who
does not have a direct or indirect employment relationship with the
facility, but is working in collaboration with a physician, to certify
and recertify that extended care services are needed or continue to be
needed. This provision took effect upon enactment.
Current regulations located at 42 CFR part 424, concerning
conditions for Medicare payments, specify that a physician must certify
and recertify the need for services. Regulations located at Sec. 424.20
provide Medicare Part A coverage for post-hospital SNF care furnished
by a SNF or a swing-bed hospital only if a physician certifies and
recertifies the need for those services. Section 424.20(a)(2) contains
certification requirements for certain swing-bed hospital patients
under which a physician must certify that transfer to a SNF is not
medically appropriate. Also, Sec. 424.20(e) provides that certification
and recertification statements may be signed by the physician
responsible for the case or, with his or her authorization, by a
[[Page 38267]]
physician on the SNF staff or a physician who is available in case of
an emergency and has knowledge of the case.
II. Provisions of the Proposed Rule
On June 28, 1991, we published a proposed rule (56 FR 29609) that
would authorize nurse practitioners and clinical nurse specialists
working in collaboration with a physician to certify and recertify that
extended care services are needed or continue to be needed. In the
preamble to that proposed rule, we described our policies concerning
requirements for certification and recertification of need for extended
care services, and proposed the following changes to the regulations:
We proposed to revise Secs. 424.1(b)(1) and 424.5(a)(4),
concerning the general provisions of part 424, by deleting the
statement that only a physician can certify and recertify the need for
extended care services.
We proposed to revise Sec. 424.10(a), which specifies that
certifications and recertifications must be made only by a physician,
to permit a nurse practitioner or clinical nurse specialist to certify
and recertify the need for services.
We proposed to revise Sec. 424.11(b), which specifies
procedures for obtaining certifications and recertifications, to remove
the requirement that only a physician can certify and recertify the
need for services.
We proposed to add a new Sec. 424.11(e)(4) to specify that
a nurse practitioner or clinical nurse specialist could certify and
recertify that extended care services are needed or continue to be
needed.
We proposed to revise Sec. 424.20(e), which pertains to
the requirements for post-hospital SNF care, by adding a new provision
to specify that the signer of the certification and recertification may
be a nurse practitioner or clinical nurse specialist, provided that
neither has a direct or indirect employment relationship with the
facility, but is working in collaboration with a physician. In this
section we also proposed that ``collaboration'' means a process whereby
a nurse practitioner or clinical nurse specialist works with a doctor
of medicine or osteopathy to deliver health care services. We further
proposed that the services must be delivered within the scope of the
practitioner's professional expertise as defined and as licensed by the
State, with medical direction and appropriate supervision as provided
for in guidelines jointly developed by the practitioner and the
physician or other mechanisms defined by Federal regulations and the
law of the State in which the services are performed.
III. Analysis of and Response to Public Comments
In response to the June 28, 1991 proposed rule, we received 16
timely items of correspondence. The comments, submitted by or on behalf
of long term care facilities, hospitals, providers of rehabilitative
services, and nursing associations, and our responses, are presented
below.
A. The Conditions and Scope of Practice Under Which a Nurse
Practitioner or Clinical Nurse Specialist May Certify or Recertify the
Need for Extended Care Services
Section 6028 of OBRA '89 amended section 1814(a)(2) of the Act to
allow, in the case of extended care services, a nurse practitioner or
clinical nurse specialist who does not have a direct or indirect
employment relationship with the facility, but is working in
collaboration with a physician, to certify and recertify that extended
care services are needed or continue to be needed.
1. Comments and Responses
Comment: One commenter stated that before residents are certified
or recertified for post-hospital SNF care for rehabilitation services
only, the nurse practitioner or clinical nurse specialist should be
required to consult with a rehabilitation professional in one or more
of the relevant disciplines of physical therapy, occupational therapy,
and speech-language pathology. The commenter believes that this should
be made a requirement because assessment of the rehabilitative needs of
the residents requires the input of professionals with specialized
clinical training.
Response: Current law does not provide for the requirement of such
a consultation. However, this type of consultation may result from the
collaborative arrangements currently in place between the nurse
practitioner or clinical nurse specialist and the physician.
Collaborative arrangements provide for discussion of patient diagnosis
and concerns related to case management to ensure the best care
possible for the patient. The nurse practitioner or clinical nurse
specialist, while working under clearly defined guidelines developed
with the physician, may determine in certain instances that
consultation with a rehabilitation professional is necessary.
In addition, under the SNF requirements for participation at
Sec. 483.20(b)(5), each resident must receive a comprehensive
assessment upon admission and a review of that assessment at least once
every 3 months. The assessment must be conducted by a nurse and involve
other practitioners as needed. A nurse practitioner or clinical nurse
specialist who is performing a certification or recertification will
have access to the assessment and will thus have the benefit of any
assessment done by rehabilitation specialists.
Also, under the SNF requirements for participation at
Sec. 483.20(d), the SNF must develop a comprehensive care plan for each
resident that includes measurable objectives and timetables to meet the
resident's medical, nursing, and mental and psychosocial needs that are
identified in the comprehensive assessment. The care plan must be
prepared by an interdisciplinary team that includes the attending
physician, a registered nurse, and ``other appropriate staff in
disciplines as determined by the resident's needs.'' Accordingly, for a
resident certified for SNF care for rehabilitation services, we expect
that the interdisciplinary team that prepares a care plan would include
a rehabilitation professional.
Comment: Three commenters stated that allowing nurse practitioners
and clinical nurse specialists to certify and recertify that extended
care services are needed or continue to be needed is an extremely
narrow function when it is delegated only to those who work directly
with attending physicians. The commenters believe that this provision
should be expanded to include facility-employed nurse practitioners and
clinical nurse specialists.
Response: Facility-employed nurse practitioners and clinical nurse
specialists are prohibited by section 1814(a)(2) of the Act from
providing certification and recertification services for a facility;
therefore, we cannot adopt the commenter's suggestion. However, the
requirements for certification and recertification authorizations are
not limited to those individuals who work directly with attending
physicians. The nurse practitioner or clinical nurse specialist is free
to engage in independent practice (if allowed by State law) so long as
he or she works in collaboration with a physician. This process allows
each professional to retain responsibility for his or her respective
services and engage in those services independently.
Comment: One commenter expressed concern that the prohibition that
the nurse practitioner or clinical nurse specialist cannot work for the
facility will have adverse effects on small rural hospitals. The
commenter noted that, in rural areas, skilled nursing facilities are
[[Page 38268]]
often faced with dual problems. First, facilities in rural areas have a
difficult time recruiting physicians. Since not many physicians live
near the facility, it is difficult to find a physician who will make
the long-distance visits to certify (or supervise) the care of
residents in SNFs. Second, a nurse practitioner or clinical nurse
specialist who lives close enough to the SNF is likely to already be
employed by the SNF, since that is likely the only employment that
would be available in that area. Thus, not only are nurse practitioners
and clinical nurse specialists a less costly alternative for the
facility to employ, but they generally must be an employee if the
facility wishes to retain their services. The commenter suggested that
a waiver be considered to allow nurse practitioners and clinical nurse
specialists who are employed by rural facilities to certify and
recertify the need or continued need for extended care services.
Response: The statute does not authorize us to grant a waiver to
allow nurse practitioners and clinical nurse specialists who are
employed by rural facilities to perform certification and
recertification. However, those who are authorized by section
1861(s)(2)(K)(iii) of the Act to engage in independent practice, and
are working in collaboration with a physician, can provide the service
of certifying and recertifying extended care services in a high
quality, cost-effective manner. Similarly, nurse practitioners and
clinical nurse specialists who work directly for a physician who is not
an employee of the facility can also provide this service. These types
of arrangements will reduce the need for visits to the nursing facility
by a physician solely for the purpose of meeting the signature
requirements, and thus free physicians to deliver medical care that
only they can furnish. We believe that such arrangements can provide
some relief to those rural areas where it is often difficult to recruit
and retain physicians.
Comment: One commenter noted that many smaller facilities would
have to pay an outside nurse to certify and recertify patients, which
would result in a direct or indirect employment relationship with the
facility.
Response: When nurse practitioners or clinical nurse specialists
are employees of qualified legal entities, under the common law test of
section 210(j) of the Act (more fully set forth in 20 CFR 404.1005,
404.1007, and 404.1009, which set forth definitions of employers and
employees for purposes of social security benefits), they are
considered for the purposes of this provision to have a direct or
indirect employment relationship. Qualified legal entities may include
the facility or someone working on the medical staff of the facility.
These provisions set forth a number of factors that indicate whether a
nurse practitioner or clinical nurse specialist has a direct or
indirect employment relationship including, but not limited to the
following:
The facility or someone on its medical staff has the
authority to hire or fire the nurse;
The facility or someone on its medical staff furnishes the
equipment and the place to work, sets the hours, and pays the nurse by
the hour, week or month;
The facility or someone on its medical staff restricts the
nurse's ability to work for someone else or provides training and
requires the nurse to follow instructions.
However, even though a facility may make direct payment to an
independent practice nurse practitioner or clinical nurse specialist
for the certification and recertification of extended care services,
that individual is not considered to have a direct or indirect
relationship with the facility as long as he or she does not perform
other duties for the facility or someone on its staff, or is not under
the control of the facility or someone on its staff.
Comment: One commenter stated that nurse practitioners and clinical
nurse specialists should be given a wider scope of practice by the
Federal Government in a manner similar to that in which States have
used their services, that is, permit them to replace physician visits
in the nursing home and have prescriptive authority within the nursing
home.
Response: We understand the commenter's concerns, but note that the
sole purpose of this rule is to implement section 1814(a)(2) of the
Act, as amended by section 6028 of OBRA '89, which is relatively narrow
in focus. Therefore, we do not have present legal authority to increase
the scope of practice of nurse practitioners or clinical nurse
specialists. However, it also should be noted that, in recent years,
the Congress has continued to expand Medicare coverage of services
furnished by nurse practitioners and clinical nurse specialists, which
helps improve beneficiary access to medical services. For example,
section 4155(a)(3) of the Omnibus Budget Reconciliation Act of 1990
(Pub. L. 101-508) amended section 1861(s)(2)(K) of the Act to authorize
Medicare coverage for certain services performed by a nurse
practitioner or a clinical nurse specialist working in a rural area.
Those services were previously covered only if performed by a
physician. In addition, Sec. 483.40 permits a physician to delegate
certain tasks, including some physician visits, to nurse practitioners
or clinical nurse specialists (as well as to physician assistants) with
certain limitations, providing they are within the scope of State law.
In these cases, however, the expansion in coverage was the direct
result of a change in law, not an administrative decision.
Comment: Another commenter believes that HCFA should extend the
signature authority to certification and recertification of specific
types of health services within the extended care setting. This could
include the plan of treatment requirements for outpatient physical
therapy and speech language pathology, and the certification and
recertification of the comprehensive outpatient rehabilitation facility
benefit.
Response: Again, section 1814(a)(2) of the Act, as amended by
section 6028 of OBRA '89, applies only to the certification and
recertification of extended care services, which is the only subject of
this final rule. The certification and recertification signature
requirements for the various outpatient services mentioned in the above
comment are addressed in other sections of the law and regulations.
2. Weight Given to Physician's Opinions
Subsequent to the June 28, 1991 proposed rule concerning
certifications by nurse practitioners and clinical nurse specialists,
we published a HCFA Ruling (No. 93-1, May 1993) that clarified HCFA's
position regarding the weight to be given to a treating physician's
opinion in determining Medicare coverage of inpatient hospital and SNF
care. Although this ruling focused on certifications by physicians, it
has significant implications for certifications by nurse practitioners
and clinical nurse specialists. Therefore, although no commenter
explicitly raised this issue, we believe it is appropriate to make an
additional clarification regarding the scope of authority of a nurse
practitioner and clinical nurse specialist. Specifically, we wish to
clarify that although completion of the required certification or
recertification is a prerequisite for Medicare SNF coverage, it does
not absolutely ensure coverage. In order to qualify for coverage, the
care must also meet Medicare's overall requirement of being reasonable
and necessary for diagnosing or treating the beneficiary's condition
(section 1862(a)(1) of the Act). This aspect of the certification and
recertification requirement is discussed in detail in HCFA Ruling No.
93-1. As
[[Page 38269]]
the ruling indicates, the treating physician's certification or
recertification of the need for care is to be given great weight in
determining SNF coverage, but coverage decisions are not made solely
based on this certification: ``* * *if the attending physician's
certification of the medical need for services is consistent with other
records submitted in support of the claim for payment, the claim is
paid. However, if the medical evidence is inconsistent with the
physician's certification, the medical review entity considers the
attending physician's certification only on a par with the other
pertinent medical evidence'' (HCFAR 93-1-8).
Thus, although an attending physician's certification or
recertification that care is needed is to be given great weight in
determining SNF coverage, we do not consider a certification or
recertification irrefutable in the face of medical evidence to the
contrary. We do not believe that a certification or recertification
should be considered more binding when completed by a nurse
practitioner or clinical nurse specialist than it would have been if
completed by the attending physician. Therefore, it is possible for a
nurse practitioner or clinical nurse specialist's certification of the
need for care to be superseded by medical evidence to the contrary,
which can include the opinion of the attending physician. We do not
anticipate that such a certification or recertification would be
completed in direct contradiction to the attending physician's opinion.
For example, if the attending physician disagrees with a nurse
practitioner's or clinical nurse specialist's certification of the need
for care, the medical review entity can deny coverage, provided that
the attending physician's opinion is consistent with the medical
evidence in the file.
B. The Definition of ``Collaboration''
In the proposed rule of June 28, 1991, we defined ``collaboration''
as a process whereby a nurse practitioner or clinical nurse specialist
works with a doctor of medicine or osteopathy to deliver health care
services. The services are delivered within the scope of the
practitioner's professional expertise with medical direction and
appropriate supervision as provided for in guidelines jointly developed
by the practitioner and the physician, or other mechanisms defined by
Federal regulations and the law of the State in which the services are
performed.
Comment: One commenter maintained that HCFA's proposed definition
of ``collaboration,'' which provides that appropriate supervision
should be provided, implies that a physician should be physically
present. The commenter believes this implication is overreaching and
does not reflect the professional practice of these practitioners. The
commenter contends that physicians are not physically present in the
facility at the same time the services are performed.
Response: We do not believe that our proposed definition is
overreaching. The requirement that collaboration entail medical
direction and supervision does not imply that the physician be
physically present in the facility or even that the physician be
consulted on each patient. Our definition is meant to apply to the
overall relationship between the physician and the nurse practitioner
or clinical nurse specialist. Thus, we envision that collaboration
would involve some systematic formal planning, assessment, and a
practice arrangement that reflects and demonstrates evidence of
consultation, recognition of statutory limits, clinical authority, and
accountability for patient care, according to some mutual agreement
that allows each professional to function independently.
C. The Limitation on Authorization To Sign Certification and
Recertification Statements
In the June 28, 1991, proposed rule, we proposed to revise
Sec. 424.11(e) to specify that nurse practitioners and clinical nurse
specialists be authorized to sign certifications and recertifications
for extended care services. We defined these entities as individuals,
licensed by the State, who meet the requirements in Sec. 424.20(e).
Comment: One commenter suggested that regulations should provide
that the physician assistant, as well as the nurse practitioner and
clinical nurse specialist, be allowed to certify and recertify
residents for Medicare benefits.
Response: Under current law, physician assistants are not allowed
to perform these certifications and recertifications. Section 6028 of
OBRA '89 extended the signature authorization for certification and
recertification to nurse practitioners and clinical nurse specialists
only.
Comment: One commenter indicated that the criteria in the proposed
rule that require State licensure for the nurse practitioner and
clinical nurse specialist to meet the signature authorization
requirements place restraints on many of the nurse practitioners and
clinical nurse specialists who are not formally recognized through
their State practice acts (that is, formal licensure requirements), but
who are not prevented from practicing in those same States. The
commenter believes that the lack of a formal licensure program should
not prevent this provision from being implemented in a State.
Response: We agree that the proposed qualifications requiring State
licensure are unduly restrictive on those nurse practitioners and
clinical nurse specialists who are in States that currently authorize
them to practice under State law, even though no formal licensure
exits. Therefore, we are revising proposed Sec. 424.11(e) to eliminate
the requirement for State licensure. Instead, we are setting forth the
necessary qualifications that nurse practitioners and clinical nurse
specialists must meet for purposes of this provision. As detailed
below, these qualification requirements will ensure that the signature
authority is extended to nurse practitioners and clinical nurse
specialists who are currently authorized under State law to perform
such services, even if no formal licensure exists.
Nurse practitioners and clinical nurse specialists are primary
health care providers. As a primary health care provider, the nurse
practitioner and/or clinical nurse specialist manages care under a
framework that includes assessment of health status, diagnosis,
development of a treatment plan, implementation of that plan, follow
up, and patient education. The autonomous nature of advanced practice
nursing requires accountability for outcomes in health care.
In the early years, many of the nurse practitioner and clinical
nurse specialist programs were hospital based certificate programs that
provided basic education and clinical requirements that were very
similar to the requirements that Medicare established in regulations
for rural health clinics in Sec. 491.2. In the late 1970's, post-basic
advanced practice programs began to evolve in response to societal and
health care needs and are rapidly being phased out in favor of master's
programs. Most of the educational preparation now required is defined
by guidelines established by the profession to assure appropriate
knowledge and clinical competency necessary for the delivery of primary
health care.
A formal, graduate educational program provides the nurse
practitioner and clinical nurse specialist the theoretical knowledge
and clinical skills appropriate for their scope of practice that
includes clinical, technical and ethical learning experiences for
delivery of care and role development in advanced nursing practice.
Formal graduate education also enables nurse
[[Page 38270]]
practitioners and clinical nurse specialists to achieve and maintain
national certification and recognition. Currently, for the nurse
practitioner, 47 States require at least national certification or a
master's degree and/or completion of an advanced practice program. For
the clinical nurse specialist, 29 States specify a graduate degree and/
or national certification. For the remaining States, advanced practice
nursing is not recognized, the authority to practice is covered under a
broad Nurse Practice Act, or, in still others, the scope of practice is
based on the registered nurse's own determination of education,
experience and amount of physician supervision necessary to conduct
practice safely.
The completion of a formal, graduate education program ensures that
the nurse practitioner and clinical nurse specialist acquire and
maintain the theoretical knowledge and clinical skills appropriate for
the certification and recertification of extended care services.
Therefore, in this final rule we are requiring master's preparation for
entry level nurse practitioners and clinical nurse specialists who
certify and recertify SNF residents. We believe that this requirement
is consistent with the training requirement currently associated with
advanced practice nursing specialties.
We also intend to allow nurse practitioners and clinical nurse
specialists who are currently practicing under previously set
standards, which may be less restrictive (for example, not requiring a
master's degree in nursing), to certify and recertify SNF services.
Consequently, we are providing that an individual may certify and
recertify SNF residents if the individual: is a registered professional
nurse currently licensed to practice nursing in the State where he or
she practices; is authorized to perform the services of a nurse
practitioner or clinical nurse specialist; and has received, within 36
months from the effective date of this final rule, a certificate of
completion from a formal advanced practice program that prepares
registered nurses to perform an expanded role in the delivery of
primary care.
Accordingly, we are revising Sec. 424.11(e)(5) to specify that, in
order to qualify as a nurse practitioner, an individual must:
(1) Be a registered professional nurse who is currently licensed to
practice nursing in the State where he or she practices; be legally
authorized to perform the services of a nurse practitioner in
accordance with State law; and have a master's degree in nursing;
(2) Be certified as a nurse practitioner by a duly recognized
professional association that has, at a minimum, eligibility
requirements that meet the standards in Sec. 424.11(e)(5)(i) (that is,
in item (1) immediately above); or
(3) Meet the requirements for a nurse practitioner set forth in
Sec. 424.11(e)(5)(i), except for the master's degree requirement, and
have received before August 25, 1998 a certificate of completion from a
formal advanced practice program that prepares registered nurses to
perform an expanded role in the delivery of primary care.
We have chosen a 36-month period for two reasons. First, we note
that most advanced nursing programs are from one to two years in
length, and we want to be sure that students currently or soon to be
enrolled in existing non-master's programs would be able to complete
their training and be eligible for Medicare participation without the
need to change programs. Secondly, we want to provide the institutions
operating the programs with enough time to react to these regulations.
Our research to date leads us to believe that non-master's advanced
programs are steadily being converted to master's degree programs and
we therefore believe that this requirement may well affect the timing
of institutional decisions for conversion, rather than the nature of
those decisions. We welcome comments on this particular issue.
In addition, under revised Sec. 424.11(e)(6), in order to qualify
as a clinical nurse specialist the individual must:
(1) Be a registered professional nurse who is currently licensed to
practice nursing in the State where he or she practices; be legally
authorized to perform the services of a clinical nurse specialist in
accordance with State law; and have a master's degree in a defined
clinical area of nursing;
(2) Be certified as a clinical nurse specialist by a duly
recognized professional association that has, at a minimum, eligibility
requirements that meet the standards in Sec. 424.11(e)(6)(i) (that is,
item (1)); or
(3) Meet the requirements for a clinical nurse specialist set forth
in Sec. 424.11(e)(6)(i), except for the master's degree requirement,
and have received before August 25, 1998, a certificate of completion
from a formal advanced practice program that prepares registered nurses
to perform an expanded role in the delivery of primary care.
As noted above, we are adding the above provisions as a result of a
public comment on our June 28, 1991 proposed rule. However, since it
would have been difficult for readers to anticipate the changes that
are necessary in this final rule, we are accepting public comments on
the qualification requirements set forth in new Sec. 424.11(e)(5) and
(6).
D. Timing of the Recertification
Neither OBRA '89 nor the June 28, 1991 proposed rule addressed the
timing of the recertification statements. However, current regulations
in Sec. 424.20(d) specify that the first recertification is required no
later than the 14th day of post-hospital SNF care, and subsequent
recertifications are required at least every 30 days after the first
recertification.
Comment: One commenter suggested that HCFA change the requirement
of recertification for medical and health services, from every 30 days
to monthly.
Response: The timing requirements for certification and
recertification were not addressed in the proposed rule and thus are
not the subject of this regulation. We note, however, that the
requirements are stated in regulations (Sec. 424.20(d)) in terms of
days because they must relate to an admission, which may occur any time
during a month. We do not believe that it would be appropriate to
restate these requirements in terms of months. Such a change could
result in extending the period between recertifications to 60 days if a
recertification took place on the 1st day of one month and on the last
day of the next month.
IV. Provisions of the Final Rule With Comment Period
For the most part, the final rule adopts the provisions of the
proposed rule. Those provisions of the final rule that differ from the
proposed rule follow.
In the proposed rule, we added a new Sec. 424.11(e)(4) to extend to
nurse practitioners and clinical nurse specialists the authority to
sign statements that would certify and recertify that extended care
services are needed or continue to be needed. We proposed that nurse
practitioners and clinical nurse specialists must be licensed by the
State in order to be authorized to sign these statements. As a result
of public comment, in this final rule we are revising Sec. 424.11(e)(4)
of the proposed rule to delete the licensure requirement. Instead, as
discussed above in section III.C. of this preamble, we are adding
paragraphs (e)(5) and (e)(6) to Sec. 424.11(e) to set forth specific
qualification requirements for nurse practitioners and clinical nurse
specialists, respectively, for purposes of the certification
provisions. We are
[[Page 38271]]
accepting public comments on these provisions.
V. Impact Statement
Unless the Secretary certifies that a rule will not have a
significant economic impact on a substantial number of small entities,
we generally prepare a regulatory flexibility analysis that is
consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
through 612) . For purposes of the RFA, physicians are considered to be
small entities. We also consider nurses who work on a consulting basis
or who are self-employed to be small entities.
Section 1102(b) of the Act requires the Secretary to prepare a
regulatory impact analysis for any rule that may have a significant
impact on the operations of a substantial number of small rural
hospitals. Such an analysis must conform to the provisions of section
604 of the RFA. With the exception of hospitals located in certain
rural counties adjacent to urban areas, 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
50 beds.
As discussed in preceding sections of this preamble, this final
rule implements section 6028 of OBRA '89 concerning the expansion of
the certification and recertification authority for extended services
to nurse practitioners and certified nurse specialists. In view of the
specificity of the statutory provisions, we considered no alternatives
beyond those raised by commenters. Any economic effects of this rule
stem directly from the OBRA '89 provisions. However, we believe that
economic effects of this rule are minimal. We do anticipate that the
implementation of the provision to allow nurse practitioners and
clinical nurse specialists to certify and recertify that extended care
services are needed will be beneficial to physicians since this will
free physicians to perform other procedures that require their
professional expertise.
In the proposed rule (56 FR 29611), we stated that the proposed
changes to the regulations would not produce any effects that would
have a significant effect on the economy or on a substantial number of
small entities. We received no comments on this assertion. The only
change that we are making in this final rule is to clarify that these
provisions will apply to nurse practitioners and clinical nurse
specialists when they are authorized under State law to perform
services even if no formal licensure exists. This change will have no
significant economic effect.
We have determined, and the Secretary certifies, that this final
rule will not have a significant effect on the operations of a
substantial number of small entities or on small rural hospitals.
Therefore, we have not prepared a regulatory flexibility analysis or an
analysis of the effects of this rule on small rural hospitals.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
VI. Collection of Information Requirements
Section 424.20 of the regulations contains information collection
requirements. The information collection requirements concern the
signatures for certification and recertification statements for
extended care services. The respondents who will be responsible are
physicians, nurse practitioners or clinical nurse specialists working
in collaboration with a physician. Public reporting burden for this
collection of information is estimated to be 1 hour per response.
The requirements contained in Sec. 424.20 were approved by OMB on
May 3, 1991, in accordance with the Paperwork Reduction Act (44 U.S.C.
3501 et seq.). The OMB approval number is 0938-0454, and the expiration
date is March 31, 1998.
VII. Response to Comments
Because of the large number of items of correspondence we normally
receive on FR documents published for comment, we are not able to
acknowledge or respond to them individually. We will consider all
comments we receive about the qualification requirements for nurse
practitioners or clinical nurse specialists by the date and time
specified in the DATES section of this preamble, and, if we proceed
with a subsequent document, we will respond to the comments in the
preamble to that document.
List of Subjects in 42 CFR Part 424
Assignment of benefits, Physician certification, Claims for
payment, Emergency services, Plan of treatment.
42 CFR chapter IV, part 424, is amended as follows:
PART 424--CONDITIONS FOR MEDICARE PAYMENT
1. The authority citation for part 424 is revised to read as
follows:
Authority: Secs. 216(j), 1102, 1814, 1815(c), 1835, 1842(b),
1861, 1866(d), 1870(e) and (f), 1871, 1872 and 1883(d) of the Social
Security Act (42 U.S.C. 416(j), 1302, 1395f, 1395g(c), 1395n,
1395u(b), 1395x, 1395cc(d), 1395gg(e) and (f), 1395hh, 1395ii and
1395tt(d)).
2. In Sec. 424.1, the introductory text of paragraph (b) is
republished and paragraph (b)(1) is revised to read as follows:
Sec. 424.1 Basis and scope.
* * * * *
(b) Scope. This part sets forth certain specific conditions and
limitations applicable to Medicare payments and cites other conditions
and limitations set forth elsewhere in this chapter. This subpart A
provides a general overview. Other subparts deal specifically with--
(1) The requirement that the need for services be certified and
that a physician establish a plan of treatment (subpart B);
* * * * *
3. In Sec. 424.5, the introductory text of paragraph (a) is
republished and paragraph (a)(4) is revised to read as follows:
Sec. 424.5 Basic conditions.
(a) As a basis for Medicare payment, the following conditions must
be met:
* * * * *
(4) Certification of need for services. When required, the provider
must obtain certification and recertification of the need for the
services in accordance with subpart B of this part.
* * * * *
4. The heading for subpart B is revised to read:
Subpart B--Certification and Plan of Treatment Requirements
5. Section 424.10 is revised to read as follows:
Sec. 424.10 Purpose and scope.
(a) Purpose. The physician has a major role in determining
utilization of health services furnished by providers. The physician
decides upon admissions, orders tests, drugs, and treatments, and
determines the length of stay. Accordingly, sections 1814(a)(2) and
1835(a)(2) of the Act establish as a condition for Medicare payment
that a physician certify the necessity of the services and, in some
instances, recertify the continued need for those services.
Section 1814(a)(2) of the Act also permits nurse practitioners or
clinical nurse specialists to certify and recertify the need for post-
hospital extended care services.
[[Page 38272]]
(b) Scope. This subpart sets forth the timing, content, and
signature requirements for certification and recertification with
respect to certain Medicare services furnished by providers.
6. In Sec. 424.11, paragraph (b) is revised, the introductory text
of paragraph (e) is revised, and new paragraphs (e)(4), (e)(5), and
(e)(6) are added to read as follows:
Sec. 424.11 General procedures.
* * * * *
(b) Obtaining the certification and recertification statements. No
specific procedures or forms are required for certification and
recertification statements. The provider may adopt any method that
permits verification. The certification and recertification statements
may be entered on forms, notes, or records that the appropriate
individual signs, or on a special separate form. Except as provided in
paragraph (d) of this section for delayed certifications, there must be
a separate signed statement for each certification or recertification.
* * * * *
(e) Limitation on authorization to sign statements. A certification
or recertification statement may be signed only by one of the
following:
* * * * *
(4) A nurse practitioner or clinical nurse specialist, as defined
in paragraph (e)(5) or (e)(6) of this section, in the circumstances
specified in Sec. 424.20(e).
(5) For purposes of this section, to qualify as a nurse
practitioner, an individual must--
(i) Be a registered professional nurse who is currently licensed to
practice nursing in the State where he or she practices; be authorized
to perform the services of a nurse practitioner in accordance with
State law; and have a master's degree in nursing;
(ii) Be certified as a nurse practitioner by a professional
association recognized by HCFA that has, at a minimum, eligibility
requirements that meet the standards in paragraph (e)(5)(i) of this
section; or
(iii) Meet the requirements for a nurse practitioner set forth in
paragraph (e)(5)(i) of this section, except for the master's degree
requirement, and have received before August 25, 1998 a certificate of
completion from a formal advanced practice program that prepares
registered nurses to perform an expanded role in the delivery of
primary care.
(6) For purposes of this section, to qualify as a clinical nurse
specialist, an individual must--
(i) Be a registered professional nurse who is currently licensed to
practice nursing in the State where he or she practices; be authorized
to perform the services of a clinical nurse specialist in accordance
with State law; and have a master's degree in a defined clinical area
of nursing;
(ii) Be certified as a clinical nurse specialist by a professional
association recognized by HCFA that has at a minimum, eligibility
requirements that meet the standards in paragraph (e)(6)(i) of this
section; or
(iii) Meet the requirements for a clinical nurse specialist set
forth in paragraph (e)(6)(i) of this section, except for the master's
degree requirement, and have received before August 25, 1998 a
certificate of completion from a formal advanced practice program that
prepares registered nurses to perform an expanded role in the delivery
of primary care.
7. In Sec. 424.20, the introductory text and paragraph (e) are
revised to read as follows:
Sec. 424.20 Requirements for posthospital SNF care.
Medicare Part A pays for posthospital SNF care furnished by a SNF,
or a hospital or RPCH with a swing-bed approval, only if the
certification and recertification for services are consistent with the
content of paragraph (a) or (c) of this section, as appropriate.
* * * * *
(e) Signature. Certification and recertification statements may be
signed by--
(1) The physician responsible for the case or, with his or her
authorization, by a physician on the SNF staff or a physician who is
available in case of an emergency and has knowledge of the case; or
(2) A nurse practitioner or clinical nurse specialist, neither of
whom has a direct or indirect employment relationship with the facility
but who is working in collaboration with a physician. For purposes of
this section, collaboration means a process whereby a nurse
practitioner or clinical nurse specialist works with a doctor of
medicine or osteopathy to deliver health care services. The services
are delivered within the scope of the nurse's professional expertise,
with medical direction and appropriate supervision as provided for in
guidelines jointly developed by the nurse and the physician or other
mechanisms defined by Federal regulations and the law of the State in
which the services are performed.
* * * * *
(Catalog of Federal Domestic Assistance Program No. 93.774,
Medicare--Supplementary Medical Insurance Program)
Dated: April 4, 1994.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
Dated: February 18, 1995.
Donna E. Shalala,
Secretary.
[FR Doc. 95-18282 Filed 7-25-95; 8:45 am]
BILLING CODE 4120-01-P
