Medicare Program; Allowing Certifications and Recertification by Nurse Practitioners and Clinical Nurse Specialists for Certain Services

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