[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