Medicare and Medicaid Programs; Religious Nonmedical Health Care Institutions and Advance Directives
Federal RegisterNov 30, 1999
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SUMMARY: This rule deletes all references to Christian Science
sanatoria and sets forth the Medicare requirements for coverage and
payment of services furnished by religious nonmedical health care
institutions. It also sets forth the conditions of participation that
religious nonmedical health care institutions must meet before they can
participate in Medicare. It sets forth the methods we will use to pay
religious nonmedical health care institutions and monitor expenditures
for religious nonmedical health care institution services.
Additionally, the rule presents the rules governing optional coverage
of religious nonmedical health care institution services by States
under the Medicaid program.
DATES: Effective date: These regulations are effective January 31,
2000.
The incorporation by reference of the publication in this rule was
approved by the Director of the Federal Register as of January 31,
2000.
Comment date: Comments will be considered if we receive them at the
appropriate address, as provided below, no later than 5 p.m. on January
31, 2000.
ADDRESSES: Mail an original and 3 copies of written comments to the
following address: Health Care Financing Administration, Department of
Health and Human Services, Attention: HCFA-1909-IFC, P.O. Box 8017,
Baltimore, MD 21244-9016.
If you prefer, you may deliver an original and 3 copies of your
written comments to one of the following addresses:
Room 309-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW,
Washington, DC 20201, or Room C5-09-26, 7500 Security Boulevard,
Baltimore, Maryland 21244-1850.
For further information on ordering copies of the Federal Register
contained in this document, see the beginning of SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT:
General Information, Medicare Coverage, and Payment Issues: Jean-Marie
Moore, (410) 786-3508
Medicare Conditions of Participation: Nancy Archer, (410) 786-0596
Medicaid Issues: Linda Tavener, (410) 786-3838.
SUPPLEMENTARY INFORMATION:
Comments, Procedures, and Availability of Copies
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I. Introduction
Section 4454 of the Balanced Budget Act of 1997 (BBA'97), Public
Law No. 105-33, enacted August 5, 1997, which amended the Social
Security Act (the Act), deletes all references to Christian Science
sanatoria. Section 4454 provides for coverage of inpatient hospital
services and post-hospital extended care services furnished in
qualified religious nonmedical health care institutions (RNHCIs) under
Medicare and as a State Plan option under Medicaid. (We will refer to
these services as ``RNHCI services.'') While the previous provisions
were specific to Christian Science sanatoria, the new amendments make
it possible for institutions other than Christian Science facilities to
qualify as RNHCIs and to participate in Medicare and Medicaid. The
programs will only pay for nonmedical health care services furnished in
RNHCIs, as defined in the law.
This interim final rule with comment period sets forth the
requirements that an RNHCI must meet to participate in the Medicare or
Medicaid programs. This rule permits a Medicare beneficiary to elect to
receive care in an RNHCI based on his or her own religious convictions
or to revoke that election if for any reason he or she decides to
pursue medical care. The rule describes the process involved in making
future elections. The rule sets forth conditions of participation that
an RNHCI must fully meet to participate in the Medicare program. If we
find that the accreditation of an RNHCI by a State, regional, or
national organization provides reasonable assurances, in accordance
with 42 CFR part 488, subpart A, that all of our requirements are met
or exceeded, we may treat that RNHCI as meeting the conditions of
participation.
The rule presents the methodologies under which we will pay RNHCIs,
monitor the Medicare expenditure level for RNHCI services for any given
federal fiscal year (FFY), and implement a ``sunset'' of the RNHCI
benefit. Finally, the rule revises Medicaid regulations to reflect
statutory changes and makes necessary nomenclature and conforming
changes.
II. Background
Since the beginning of the Medicare program, the Act contained
provisions authorizing payment for certain services furnished in
Christian Science sanatoria. There were similar provisions authorizing
payment for such services under Medicaid. Section 4454 of BBA'97
repealed the existing Medicare
[[Page 67029]]
and Medicaid provisions authorizing payment for services furnished in
Christian Science sanatoria. Section 4454 authorizes Medicare and
Medicaid payment for certain services provided in an RNHCI, as defined
in the statute. Services furnished in any facility that meets the
definition of an RNHCI may qualify for payment, not just those provided
in Christian Science sanatoria. It should be noted that the Medicaid
RNHCI provisions are optional and not an essential component of the
basic Medicaid State plan. As in the past, the new provisions do not
mention the use of a religious practitioner since we consider the cost
of using a religious practitioner the financial responsibility of the
patient.
III. Regulatory Provisions
A. RNHCI Medicare Benefits, Conditions of Participation, and Payment
We are revising part 403 (Special Programs and Projects) of the
Code of Federal Regulations by adding a new subpart G, ``Religious
Nonmedical Health Care Institutions-Benefits, Conditions of
Participation, and Payment.''
1. Basis and Purpose (Sec. 403.770)
This rule implements Section 4454 of BBA'97, which amended the
following sections of the Act: 1821, and 1861(e), (y) and (ss)
(Medicare provisions); 1902(a) and 1908(e)(1) (Medicaid provisions);
and 1122(h) and 1162 (conforming provisions).
Section 4454 of BBA'97 modified section 1861 of the Act in several
ways. First, section 4454 removed the reference to Christian Science
from the definition of the term ``hospital'' in section 1861(e) and
substituted ``religious nonmedical health care institution.'' Section
4454 also changed the title of section 1861(y) from ``Extended Care in
Christian Science Skilled Nursing Facilities'' to ``Extended Care in
Religious Nonmedical Health Care Institutions'' and substituted
``religious nonmedical health care institution'' for the reference to
Christian Science sanatorium in that section.
Section 4454 added new section 1861(ss) to the Act. New section
1861(ss)(1) of the Act defines the ten minimum characteristics that a
facility must have to be considered an RNHCI and provides the basis for
the Medicare conditions of participation described in this rule.
Section 4454 also added a new section 1821 to the Act, providing
conditions for coverage of RNHCI services. New section 1821(a) and (b)
of the Act addresses the requirements that the beneficiary must fulfill
to qualify for coverage and payment of RNHCI services. New section
1821(c) and (d) of the Act addresses the monitoring of expenditures for
RNHCI services, safeguards against excessive expenditures for those
services, and the circumstances under which the RNHCI benefit created
by section 4454 will ``sunset''.
Section 4454 also amends the third sentence in section 1902(a)
after the phrase ``shall not apply'' by removing the phrase ``to a
Christian Science sanatorium operated, or listed and certified, by the
First Church of Christ, Scientists, Boston, Massachusetts'' and
inserting ``to a religious nonmedical health care institution (as
defined in section 1861(ss)(1).'' Section 4454 also amends 1908(e)(1)
after the phrase ``does not include'' by removing ``a Christian Science
sanatorium operated, or listed and certified, by the First Church of
Christ, Scientist, Boston, Massachusetts'' and inserting ``a religious
nonmedical health care institution (as defined in section
1861(ss)(1)).'' These amendments to the Act provide for RNHCI services
as a State option under the Medicaid program.
2. Definitions and Terms (Sec. 403.702)
In the first section of subpart G we have included a ``definitions
section'' to assist readers with terms or acronyms that are used in the
rule. However, if a term is defined within the text of the rule, then
it is not included in the definitions section. The terms and acronyms
presented in the definitions section are as follows:
Election means a written statement signed by a beneficiary or the
beneficiary's legal representative indicating the beneficiary's choice
to receive nonmedical care or treatment for religious reasons. The term
is specific to the section 4454 provisions: it is the new process by
which a beneficiary elects to choose RNHCI services rather than other
covered medical services.
Excepted medical care means medical care that is received
involuntarily or required under Federal, State, or local laws. It is a
new term specific to the provisions implementing section 4454 and is
intended to identify the kinds of medical services that can be provided
to a beneficiary with an election for RNHCI services without revoking
the election.
FFY is the acronym for the Federal fiscal year, which is the period
used in calculating budget figures for the RNHCI program.
Medical care or treatment means health care furnished by or under
the direction of a licensed physician that can involve diagnosing,
treating, or preventing disease and other damage to the mind and body.
It may involve the use of pharmaceuticals, diet, exercise, surgical
intervention, and technical procedures.
Nonexcepted medical care means medical care, other than excepted
medical care, that is sought by or for a beneficiary who has elected
religious nonmedical health care institution services. It is a new term
specific to the provisions implementing section 4454 and is intended to
define the kinds of medical services that, if received by a beneficiary
who has previously elected RNHCI services, would revoke the
individual's election of services.
Religious nonmedical care or religious method of healing means
health care furnished under established religious tenets that prohibit
conventional or unconventional medical care for the treatment of a
beneficiary. It is a term specific to the provisions implementing
section 4454 and defines a specific approach to health care management.
RNHCI stands for ``religious nonmedical health care institution''
(as defined in section 1861(ss)(1) of the Act).
Religious nonmedical nursing personnel means individuals who are
grounded in the religious beliefs of the RNHCI, trained and experienced
in the principles of nonmedical care, and formally recognized as
competent in the administration of care within their religious
nonmedical health care group. The term is specific to the provisions
implementing section 4454 and defines a specific group of health care
workers.
3. Requirements for Coverage (Sec. 403.720)
In order for a Medicare or Medicaid provider to meet the definition
of an RNHCI, it must satisfy the ten qualifying provisions as contained
in new section 1861(ss)(1) of the Act, which are simply restated in the
rule. While the requirements contained in sections 1861(ss)(1)(B)
(lawful operation), (G) (ownership by or in a provider of medical
services), and (H) (utilization review) of the Act are explicitly
addressed in the Medicare conditions of participation, it is essential
that a facility meet all ten elements to qualify as an RNHCI for both
the Medicare and Medicaid programs. Section 1861(ss)(1) of the Act
states that an RNHCI means an institution that:
(a) Is described in subsection (c)(3) of section 501 of the
Internal Revenue Code of 1986 and is exempt from taxes under subsection
(a) of that section. The inability to either gain or retain this
[[Page 67030]]
status will disqualify an institution from participation as an RNHCI.
(b) Is lawfully operated under all applicable Federal, State, and
local laws and regulations. Federal law supersedes State and local laws
unless the State and local requirements are more stringent than the
Federal requirements.
(c) Furnishes only nonmedical nursing items and services to
patients who choose to rely solely upon a religious method of healing
and for whom the acceptance of medical services would be inconsistent
with their religious beliefs. The religious component of the healing is
not covered by Medicare or Medicaid.
(d) Furnishes nonmedical items and services exclusively through
nonmedical nursing personnel who are experienced in caring for the
physical needs of these patients. This care frequently involves:
assistance with activities of daily living; assistance in moving,
turning, positioning, and ambulation; meeting nutritional needs; and
comfort and support measures.
(e) Furnishes nonmedical items and services to inpatients on a
twenty-four hour basis.
(f) Does not furnish, on the basis of its religious beliefs,
through its personnel or otherwise, medical items and services
(including any medical screening, examination, diagnosis, prognosis,
treatment, or the administration of drugs) for its patients.
(g) Is not owned by, under common ownership with, or has an
ownership interest of five percent or more in, a provider of medical
treatment or services, and is not affiliated with a provider of medical
treatment or services, or with an individual who has an ownership
interest of five percent or more in, a provider of medical treatment or
services. For purposes of this requirement, an affiliation does not
exist in the circumstances described in section 1861(ss)(4)of the Act
or Sec. 403.738(c).
(h) Has in effect a utilization review plan that:
Provides for review of admissions to the institution, of
the duration of stays, of cases of continuous extended duration, and of
the items and services furnished by the institution.
Requires that the reviews be made by an appropriate
committee of the institution that includes the individuals responsible
for overall administration and for supervision of nursing personnel at
the institution.
Provides that records be maintained of the meetings,
decisions, and actions of the committee.
Meets other requirements as the Secretary finds necessary
to establish an effective utilization review plan.
(i) Provides information the Secretary may require to implement
section 1821 of the Act, including information relating to quality of
care and coverage determinations.
(j) Meets other requirements the Secretary finds necessary in the
interest of the health and safety of individuals who are furnished
services in the institution. These requirements are the conditions of
participation in this subpart. The RNHCI must meet or exceed the
conditions of participation in order to qualify as a Medicare provider.
The conditions of participation will be discussed individually in
section III.A.5. of this preamble. The RNHCI must also have a valid
provider agreement with HCFA.
In addition to the above requirements, section 4454 of BBA'97 added
section 1821 to the Act, establishing conditions of coverage for RNHCI
services. Section 1821(a) of the Act requires that as a condition for
Part A Medicare coverage:
The beneficiary must have a condition that would qualify
under Medicare Part A for inpatient hospital services or extended care
services furnished in a hospital or skilled nursing facility that is
not an RNHCI.
When a Medicare beneficiary has an effective election on file with
us but does not have a condition that would qualify for Medicare Part A
inpatient hospital or post-hospital extended care services if the
beneficiary were an inpatient of a hospital or a resident of an SNF
that is not an RNHCI, then services furnished in a RNHCI are not
covered by Medicare. A Medicare claim for services that were furnished
to that beneficiary would be treated as a claim for uncovered services.
If the beneficiary only needs assistance with activities of daily
living, then the beneficiary's condition could not be considered as
meeting the Medicare Part A requirements.
The beneficiary must have a valid election in effect to
receive RNHCI services.
A beneficiary who meets all other applicable requirements and who
has in effect a valid election to receive services in an RNHCI is
eligible for coverage of those services in an RNHCI.
If no valid election is filed or the election has been revoked and
no new election is in effect, the beneficiary does not have Medicare
coverage for services furnished in an RNHCI. Consequently, a Medicare
claim for services furnished to such a beneficiary would also be
treated as a claim for uncovered services.
The RNHCI may not accept a patient as a Medicare or
Medicaid beneficiary after the sunset provision (Sec. 403.756) is
implemented unless the patient has an election in effect prior to
January 1 of the year in which the sunset provision is implemented. A
claim filed for payment for services furnished to a patient with no
valid election in effect before January 1 of the year the sunset
provision is implemented would be denied.
The RNHCI must, after reasonable investigation, determine
that the beneficiary has not received nonexcepted medical treatment
that would have caused his or her election to be revoked. We believe
that the RNHCI is in the best position to gain information from the
patient about health care incidents that may have occurred since first
signing an election statement that might change the election status.
Examples:
(a) During the admission interview the RNHCI became aware that
the beneficiary had been in an accident in which he or she suffered
lacerations and contusions and was massively confused when
transferred to a local emergency room. The emergency room staff
controlled the bleeding and completed repair of the lacerations and
initiated a neurological assessment before the patient's religious
preferences were known. This is considered excepted medical care
since the patient was not mentally competent to refuse the
initiation of medical care and did not voluntarily seek medical
attention. Receipt of excepted care does not revoke the
beneficiary's election for RNHCI services.
(b) During the admission interview the RNHCI becomes aware that
the beneficiary had visited a chiropractor to gain relief from
persistent back pain. This chiropractor visit is considered
nonexcepted care since the beneficiary voluntarily sought Medicare
covered medical care, which effectively revokes the election for
RNHCI services.
If the election has been revoked, it means the beneficiary and
RNHCI are responsible for the cost of services that are denied by
Medicare.
4. Valid Election Requirements (Sec. 403.724)
The new section 1821(b) of the Act addresses the issues involved in
beneficiary election of RNHCI services. None of the provisions in this
section existed prior to the passage of BBA'97.
(a) General Requirements
(i) The election must be a written statement that includes the
following statements:
The beneficiary is conscientiously opposed to acceptance
of nonexcepted medical treatment as defined in Sec. 403.702. This is a
statutory requirement that is restated in the rule.
[[Page 67031]]
The beneficiary acknowledges that the acceptance of
nonexcepted or conventional medical treatment is inconsistent with his
or her sincere religious beliefs. This is a statutory requirement that
is restated in the rule.
The beneficiary acknowledges that the receipt of
nonexcepted medical treatment constitutes a revocation of the election
and may limit further receipt of services in an RNHCI. We believe that
it is essential that the election indicate the beneficiary's
understanding as to what acts on his or her part could revoke the
election.
The beneficiary acknowledges that the election may be
revoked by submitting a written statement to HCFA. We believe that it
is essential that the election indicate the beneficiary's understanding
as to how he or she can revoke the election.
The beneficiary acknowledges that revocation of the
election will not prevent or delay access to medical services available
under Medicare Part A in facilities other than RNHCIs. We believe that
it is essential that the election indicate the beneficiary's
understanding that at no time will he or she be denied access to
Medicare Part A services.
(ii) The election must be signed and dated by the beneficiary or
his or her legal representative. We believe the election for RNHCI
services can only be made by a Medicare beneficiary or his or her legal
representative. An election may not be made by or on behalf of an
individual prior to reaching Medicare eligibility and beneficiary
status. The election may not be made for an individual by a friend or
family member who is not the legal representative of the beneficiary.
(iii) The election must be notarized. We are requiring that
election statements be signed by the beneficiary or his or her legal
representative and notarized. We believe that this is necessary to
assure the identity and relationship of the parties involved and the
beneficiary's understanding of the content of the election statement.
An election statement may neither be predated to seek coverage and
payment for services furnished prior to the date of an election nor
post-dated to meet the time limitations on making a new election
imposed by an earlier revocation (see Sec. 403.724(b)). We believe that
the beneficiary must be eligible to enter an election at the time the
document is signed and notarized.
(iv) The RNHCI must keep a copy of the election statement on file
and submit the original to HCFA with any information obtained regarding
prior elections or revocations. The maintenance of a double entry
system will assure the accuracy of a beneficiary's status and
eligibility for RNHCI services. While we require the receipt of an
original copy of the election in order to complete the filing process,
there is nothing that precludes the signing of multiple originals at
the same time. The provider or the beneficiary and his or her legal
representative may be more comfortable in having an original rather
than a copy for future reference. Having an original of the election
may be particularly important to beneficiaries who feel they might
relocate at some future date and may not be readmitted to the same
RNHCI.
(v) The election becomes effective on the date it is signed. The
dating of the election is required to establish a history that
documents the beneficiary's eligibility for RNHCI services.
(vi) The election remains in effect until revoked. Since there is
no time limitation on the term of the election statement, it will
remain effective until revoked by the written request of the
beneficiary or action of the beneficiary in seeking nonexcepted medical
care as defined in Sec. 403.702.
(b) Revocation of Election
(i) A beneficiary's election is revoked by one of the following:
The beneficiary receives nonexcepted medical treatment for
which Medicare payment is requested. Under section 1821(b)(3) of the
Act, an election by a beneficiary will be revoked if the beneficiary
receives nonexcepted medical treatment for which Medicare payment is
sought.
Nonexcepted medical treatment in this rule refers to any medical
care or treatment other than excepted medical treatment.
Examples of nonexcepted medical care could include but are not
limited to the following:
+ A beneficiary receiving medical diagnosis and/or treatment for
persistent headaches and/or chest pains.
+ A beneficiary in an RNHCI who is transferring to a community
hospital to have radiological studies and the reduction of a fracture.
+ A beneficiary with intractable back pain receiving medical,
surgical, or chiropractic services.
Under section 1821(b)(3) of the Act, an election by an
individual may also be revoked voluntarily by notifying us in writing.
(ii) The receipt of excepted medical treatment as defined in
Sec. 403.702 does not revoke the election made by a beneficiary.
Examples of excepted services include but are not limited to the
following:
+ A beneficiary who receives vaccinations required by a State or
local jurisdiction. This is compliant behavior to meet government
requirements and not considered as voluntarily seeking medical care or
services.
+ A beneficiary who is involved in an accident and receives medical
attention at the accident scene, or in transport to a hospital, or at
the hospital before being able to make their beliefs and wishes known.
+ A beneficiary who is unconscious and receives emergency care and
is hospitalized before regaining consciousness or being able to locate
his or her legal representative.
(c) Limitation on Subsequent Elections
(i) If a beneficiary's election has been made and revoked twice,
the following limitations on subsequent elections apply:
The third election is not effective until 1 year after the
date of the most recent revocation.
Any succeeding elections are not effective until 5 years
after the date of the most recent revocation.
Section 1821(b)(4) of the Act provides limitations on subsequent
elections. An individual may file an election and revoke it twice with
no affect on benefits paid under Medicare Part A for services furnished
in an RNHCI. However, once an individual's election has been made and
revoked twice, the next (third) election may not become effective until
the date that is one year after the date of the most recent revocation.
Any succeeding election (fourth or later) will not become effective
until the date that is five years after the date of the most recent
revocation. While there are progressive waiting periods for an
individual to file an election following the second revocation, there
is never a waiting period for the individual to be able to receive
covered medical services as a Medicare beneficiary.
(ii) HCFA will not accept as the basis for payment of any claim any
election filed on or after January 1 of the calendar year in which the
sunset provision described in Sec. 403.756 becomes effective. Section
1821(d) of the Act provides that if the sunset provision becomes
effective we may not accept any more elections for RNHCI services. The
sunset provision is discussed in detail in section III. A.9. and
Sec. 403.756 of this rule.
[[Page 67032]]
5. Conditions of Participation
(a) Patient Rights (Sec. 403.730)
Under section 1861(ss)(1)(J) of the Act, we may accept an RNHCI as
a participating Medicare provider only if, in addition to meeting the
specific requirements of that section, it meets other requirements we
find necessary in the interest of patient health and safety.
Patient health and safety cannot be protected simply by avoiding
obvious risk factors such as safety hazards or inadequate staff.
Therefore, patient rights dealing with freedom from physical,
psychological, and verbal abuse, misappropriation of property, and
physical restraints are examples of direct protections of patients'
physical and emotional health and safety. Successful restoration of
health depends on many factors related to emotional health, including a
general feeling of well-being. We believe patient health and safety can
be protected only if the RNHCI delivers patient care in an atmosphere
of respect for the individual patient's comfort, dignity, and privacy.
Therefore, we are setting forth a condition of participation that
recognizes explicitly that the RNHCI must protect and promote certain
patient rights.
The patients' rights condition at Sec. 403.730 has four standards.
The first standard requires that the RNHCI inform each patient of his
or her rights before furnishing care. We are not prescribing a specific
method by which a RNHCI should notify each patient of his or her
rights, because we believe that each RNHCI should implement a policy
that reflects its specific manner of operations and minimizes
administrative burden. This standard also requires that a RNHCI have a
process for prompt resolution of grievances and that it inform patients
of this process. The process must include a specific person within the
facility whom a patient can contact to file a grievance. In addition,
the facility must provide patients with contact information for
appropriate State and Federal resources.
The remaining three standards (Exercise of rights, Privacy and
safety, and Confidentiality of patient records) under the patient
rights condition establish a minimum set of required patient rights. In
developing these provisions, we closely examined the regulations
concerning patient rights for other provider types, such as nursing
homes and home health agencies. Because the nature of patient care
varies among provider types, we are including only those patient rights
that we believe are appropriate and necessary in the religious
nonmedical setting. We are requiring that a patient have the following
rights:
The right to be informed of his or her rights, to
participate in the development and implementation of his or her plan of
care, and to make decisions regarding his or her care.
The right to formulate advance directives and to have
those directives followed.
The right to privacy and to receive care in a safe
setting.
The right to be free from verbal, psychological, and
physical abuse, and misappropriation of property.
The right to confidentiality of his or her care records.
The right to be free from the use of restraints.
The right to be free from involuntary seclusion.
We believe these patient rights are necessary in the interest of
patient health and safety. We note that the rights regarding advance
directives may seem superfluous for those patients seeking nonmedical
care, but we believe that a patient always has the right to change his
or her mind regarding the method of health care he or she chooses.
Advance directives are particularly important for a patient choosing to
rely solely upon a religious nonmedical method of healing as it makes
his or her wishes known in the event he or she becomes incapacitated
and unable to make health care choices.
HCFA policy in HCFA's nursing home interpretive guidelines defines
restraints as any manual method or physical or mechanical device,
material, or equipment attached to or adjacent to the patient's body
that the individual cannot remove easily that restricts freedom of
movement or normal access to one's own body. Physical restraints
include, but are not limited to: Using bed rails to keep a patient from
voluntarily getting out of bed (as opposed to enhancing mobility while
in bed); tucking in a sheet so tightly that a bed bound patient cannot
move; using wheelchair safety bars to prevent a patient from rising
from the chair; placing a patient in a chair that prevents rising; and
placing a patient in a wheelchair so close to a wall that the wall
prevents the patient from rising. Bed rails may be used either as
restraints or to assist in mobility and transfer of a patient only. The
use of bed rails as restraints is prohibited unless they are necessary
to treat a patient's medical symptoms.
Restraint use may constitute an accident hazard and professional
standards of practice have eliminated the need for physical restraints
except under limited medical circumstances. Potential negative outcomes
for restraint use include incontinence, decreased range of motion, and
decreased ability to ambulate, symptoms of withdrawal or depression,
reduced social contact, and death. Studies have shown that bed rails as
restraints add risk to the patient by potentially increasing the risk
of more significant injury from a fall from a bed with raised rails
than from a fall from a bed without bed rails. There are other, safer
methods to reduce the risk of falls from a bed such as lowering the bed
or putting the mattress on the floor and frequent staff monitoring.
Therefore, if a cognizant, able patient requests bed rails to assist in
mobility, it is not considered a restraint. If, on the other hand, a
legal representative requests bed rails for a bed bound relative with
no medical need for bed rails, then it is considered a restraint. The
representative cannot give permission to use restraints, including bed
rails for ``safety,'' if it is not necessary to treat the patient's
medical symptoms. Restraining someone to keep him or her ``safe'' is
limited to circumstances in which the patient has medical symptoms and
a physician's order that warrant the use of a restraint (see nursing
home regulations and interpretive guidelines). Since the RNHCI
recognizes neither medical symptoms or physicians (and it is prohibited
to do so by the Act), there is no reason that a restraint may be used
in a RNHCI.
HCFA has worked for many years to reduce restraint use and is very
proud of the progress it has made in doing so. Not only would allowing
restraints in RNHCIs be counterproductive to their mission and niche,
but it would be utterly contrary to the standards that we have
developed in conjunction with other stakeholders in health care that
would permit restraints only with a medical diagnosis and medical
orders.
(b) Quality Assessment and Performance Improvement (Sec. 403.732)
We are requiring a participating RNHCI to implement a continuous
effort to improve its performance, incorporating an approach that
focuses on the RNHCI's efforts to improve patient care and
satisfaction. Specifically, we are requiring each RNHCI to develop,
implement, maintain and evaluate an effective quality assessment and
performance improvement program. We are not prescribing specific
methodologies to achieve this objective. Each RNHCI is free to pursue
quality improvement in a manner best suited to its individual
characteristics and resources. However, every RNHCI is responsible for
implementing actions that result in
[[Page 67033]]
performance improvements across the full range of the RNHCI's services
to patients. Also, we are requiring an RNHCI's quality assessment and
performance improvement program to track performance to ensure that
improvements are sustained over time.
The quality assessment and performance improvement condition
(Sec. 403.732) contains two standards, the first addressing the scope
of the program and the second concerning the responsibility for the
program. The first standard requires that an RNHCI's quality assessment
and performance improvement contain the minimum items that must be in
the RNHCI's program. Specifically, we require that the RNHCI
objectively evaluate the following areas that we believe are critical:
access to care, patient satisfaction, staff performance, complaints and
grievances, discharge planning activities, and safety issues, including
physical environment. We believe that these items comprise the
fundamental building blocks of a well-managed RNHCI.
Additionally, Sec. 403.732 states that for each area listed above,
and any other areas the RNHCI includes, the RNHCI must define and
describe quality assessment and performance improvement activities that
are appropriate for the services furnished by or in the RNHCI.
Because of the unique nature of the care furnished in RNHCIs, we
are not prescribing a specific definition of quality or outlining what
activities are appropriate to meet this standard. However, we welcome
any comments on whether the regulations should include some prescribed
methods and some definitions on the nature of quality in an RNHCI.
Additionally, the RNHCI must measure, analyze, and track
performance that the RNHCI adopts or develops that reflects processes
of care and RNHCI operations. By ``measure'' we mean that the RNHCI
must use an objective means of tracking performance that enables the
RNHCI to identify differences in performance between two points in
time. For an RNHCI to consider that it is ``doing better'' is a
subjective statement and is not an acceptable measure. There must be
some identifiable units of measurement that a knowledgeable person can
distinguish as evidence of change. Not all objective measures must be
shown as valid and reliable (that is, subjected to scientific
development) to be usable in improvement projects, but they will at
least identify a starting point and an ending point stated in objective
terms that relate to the objectives and outcomes of the improvement
projects. However, rather than mandating specific performance measures,
we are allowing each RNHCI the flexibility to identify its own measures
of performance for the activities it identifies as priorities in its
quality assessment and performance improvement strategy. We are also
requiring that the RNHCI inform the patients of the scope and
responsibilities of the quality assessment and performance improvement
program.
We also are requiring in Sec. 403.732 that an RNHCI set priorities
for performance improvement, based on the prevalence and severity of
the identified problem(s). Lastly, this standard requires the RNHCI to
take action to correct problems identified through its quality
assessment and performance improvement program. We envision an RNHCI
meeting this requirement by conducting an analysis when adverse
outcomes are identified and then taking action to enact long-term
correction and improvement of the identified problems.
The second standard, Program responsibilities, requires that the
RNHCI's governing body ensure that there is an effective quality
assessment and performance improvement program. We are requiring that
the governing body and administration officials be responsible for
ensuring that the quality assessment and performance improvement
program addresses identified priorities and be responsible for
implementing and evaluating improvements. Additionally, the standard
requires that all programs, departments, and functions be a part of the
RNHCI's quality assessment and performance improvement program. This
also includes any services carried out under contract.
(c) Food services (Sec. 403.734)
This condition has two standards. The first standard, Sanitary
conditions, requires that food provided to patients be obtained,
stored, prepared, distributed and served under sanitary conditions. We
believe that it is necessary for any acceptable food services program
to serve food that meets these criteria. The other standard requires
that meals be prepared which furnish adequate nutrition based on the
recommended dietary allowances of the Food and Nutrition Board of the
National Research Council, National Academy of Sciences. We believe
this standard is necessary to protect the health and safety of patients
in an RNHCI and that the Board's guidelines can appropriately be used
here because they represent accepted practices that are in widespread
use in other providers. We are not requiring therapeutic diets or
parenteral nutrition as these are considered medical practices.
Additionally, this standard requires that food furnished be
palatable, attractive and served at the proper temperature. The RNHCI
is also required to offer substitutes of similar nutritional value to
patients who refuse food served or desire alternative choices. All
meals are to be furnished at regular times comparable to normal
mealtimes in the community and in no instance may there be more than 14
hours between a substantial evening meal and breakfast the next day.
Additionally, there RNHCI must offer snacks at bedtime.
(d) Discharge Planning (Sec. 403.736)
Under this condition, we are requiring the RNHCI to implement a
discharge planning process to assure that appropriate post-RNHCI
services are obtained for each patient, as necessary. The discharge
planning process will apply to services furnished by the RNHCI to
ensure a timely and smooth transition to the most appropriate type of
setting for the patient. To be compatible with other regulations for
other providers, we are dividing the condition into several standards--
Discharge planning evaluation, Discharge plan, Transfer or referral,
and Reassessment.
The first standard concerns the identification of patients in need
of evaluation. We are requiring an RNHCI to assess the need for a
discharge plan for patients likely to suffer any adverse consequences
if there is no planning and for other patients upon their request. The
discharge planning process must be initiated when the patient is
admitted to the facility. Additionally, we are requiring that discharge
planning be initiated upon the request of the patient or a legal
representative acting on his or her behalf. The discharge planning
evaluation must include an assessment of the possibility of a patient
needing services after discharge and the patient's capacity for self-
care or care in the environment from which he or she entered the RNHCI.
We are requiring that the evaluation be completed on a timely basis and
included in the patient's rights record, thus ensuring that appropriate
arrangements for post-RNHCI care are made before discharge and avoiding
unnecessary delays. We believe these requirements are necessary because
they emphasize the need for prompt action to assess and act on the
discharge planning needs of the patients.
[[Page 67034]]
The second standard requires that qualified and experienced
personnel develop the discharge plan and that the RNHCI be responsible
for the implementation of the plan. We assume this plan to be
thoughtful and tailored to each individual's needs. A statement such as
``the patient was discharged to XYZ facility'' is not considered a
discharge plan. We assume the plan would provide recommendations and
arrangements for placement, either in the community or in the
environment from which the patient was admitted. The RNHCI is also
responsible for reassessing each individual's plan for factors that may
affect the appropriateness of the plan. The patient or the legal
representative must be informed and prepared for any post-RNHCI care.
Additionally, the RNHCI must inform the patient or legal representative
of his or her ability to choose among any (medical facilities or
otherwise) participating Medicare providers that will respect the
preferences of the patient and family.
The third standard requires the RNHCI to transfer or refer patients
in a timely manner to another facility (including a medical facility,
if requested by the beneficiary or his or her legal representative), in
accordance with Sec. 403.730(b)(2). The RNHCI must notify the patient
of his or her rights to make decisions about care, including transfers
and discharges, and must involve the patient in decisions about the
transfers and discharges. Furthermore, the patient always has the
choice to revoke his or her election for RNHCI care (in accordance with
the revocation provisions in Sec. 403.724(b)) in order to receive care
in a traditional medical setting. While we expect that all transfers
and referrals will be made in a timely manner, we expect that RNHCIs
will act as expeditiously as needed to implement transfers or referrals
to a medical facility that are requested by a patient after the
patient's revokes his or her election for RNHCI care.
The last standard requires the RNHCI to reassess its discharge
planning process on an ongoing basis. This reassessment must include
reviewing a sampling of discharge plans and follow-up with the patient,
if necessary, to ensure that the RNHCI was responsive to his or her
discharge needs.
(e) Administration (Sec. 403.738)
The first standard is the same as section 1861(ss)(1)(B) of the
Act, which requires the RNHCI to be operated under all Federal, State,
and local laws. The administration condition requires the RNHCI to have
written policies regarding organization, services, and administration.
This condition consists of three standards--Compliance with Federal,
State, and local laws, Governing body, and Ownership and disclosure.
In addition, we are requiring that the RNHCI meet the applicable
provisions of other HHS regulations, including but not limited to those
pertaining to nondiscrimination on the basis of race, color or national
origin (45 CFR part 80); nondiscrimination on the basis of handicap (45
CFR part 84); nondiscrimination on the basis of age (45 CFR part 91);
protection of human subjects of research (45 CFR part 46); and fraud
and abuse (42 CFR part 455). Although these regulations are not in
themselves considered requirements under this part, their violation may
result in the termination of the provider agreement or the suspension
of, or the refusal to grant or continue, payment of Federal funds to an
RNHCI.
The second standard, Governing body, described in Sec. 403.738(b),
requires that the RNHCI appoint a governing body, or a person
designated to function as a governing body, to be responsible for
establishing and implementing policies regarding the RNHCI's management
and operation. We assume that the governing body will create an
environment that ensures high quality care that is consistent with
patient needs and the effective administration of the RNHCI.
We want to emphasize that the governing body is responsible for the
entire operation of the RNHCI, including contracts, arrangements, and
the appointment of an administrator. While the governing body
requirements may necessitate the implementation of certain processes,
we believe they are essential to ensuring that the RNHCI with which
HCFA has entered into a provider agreement is, in fact, able to ensure
patient health and safety. To ensure this accountability, we have
specified the responsibility of the governing body for establishing and
implementing all policies regarding the RNHCI's management and
operation. We believe the performance of these basic organizational
functions is necessary for a patient-centered environment.
The third standard states the provisions of sections
1861(ss)(1)(G)(I) and 1861(ss)(4) of the Act, which permit ownership
interests and affiliations if they meet certain criteria. Under the
third standard, a RNHCI may not be owned by, be under common ownership
with, or have an interest in a provider of medical treatment services.
Additionally, the RNHCI may not be affiliated with a provider of
medical treatment or services or affiliated with an individual who has
an ownership interest in a provider of medical treatment or services.
Permissible affiliations are one of the following:
An individual serving as an uncompensated director,
trustee, officer, employee, or other member of the governing body of
the RNHCI, or
An individual who is a director, trustee, officer,
employee, or staff member of a RNHCI having a family relationship with
an individual who is affiliated with (or has an ownership interest in)
a provider of medical treatment or services, or
An individual or entity furnishing goods or services as a
vendor of medical treatment to both providers of medical treatment or
services and RNHCIs.
We have included the requirement that the RNHCI also comply with
ownership disclosure requirements of Secs. 420.206 and 455.104 of 42
CFR Chapter 4.
In order to adequately monitor the potential for fraud and abuse in
the program, we have added an additional requirement that the RNHCI
also furnish written notice to HCFA if a change occurs in any of the
following:
Persons with ownership or controlling interest.
The officers, directors, agents or managing employees.
The religious entity, corporation, association, or other
company responsible for the management of the RNHCI.
The administrator or director of nonmedical nursing
services.
(f) Staffing (Sec. 403.740)
Under the condition for staffing we are requiring the RNHCI to have
qualified experienced personnel present in sufficient numbers to meet
the specific needs of the patients. The overall goal of this condition
is to ensure that all the RNHCI's areas, not just those directly
involved with patient care, are staffed with sufficient, qualified
personnel. We believe an efficient and well-run institution is the
product of all staffing areas working to improve the overall quality of
the facility.
This condition is composed of three standards which support the
objective that the RNHCI be staffed with qualified personnel. The first
of these standards, Personnel qualifications, concerns qualifications
of those individuals who furnish care to patients. We want to emphasize
that the standard applies to all such individuals, whether or not they
are employed or compensated by the RNHCI or, if they are compensated,
[[Page 67035]]
whether salaried or contractors. This standard reflects our view that
the conditions of participation for RNHCIs should not prescribe
specific Federal personnel requirements for nonmedical personnel or
attempt to limit or specify the functions they may perform.
The next standard, Education, training, and performance evaluation,
is intended to ensure that the RNHCI staff are aware of their job
responsibilities and are capable of meeting them. We are requiring that
personnel receive education or training needed to help them achieve
this goal. This education may include training that is related to the
individual job description, performance expectations, applicable
organizational policies and procedures, and safety responsibilities. We
are emphasizing that under this standard, the RNHCI is responsible only
for ensuring that the individual adequately knows the nature of his or
her specific job duties. The individual is responsible for his or her
own basic education, and for any continuing education needed to retain
specific certification(s), unless the RNHCI chooses to assume this
responsibility as part of the staff development process.
The second part of this standard requires all personnel in the
RNHCI, as well as contractors and individuals working under
arrangement, to demonstrate in practice the skills and techniques
necessary to perform their assigned duties and responsibilities. It is
not enough that the RNHCI demonstrates that staff has received
training, or indicate how much training has been offered or provided.
For effective health and safety of the patients, it is critical that
all staff use the skills and techniques necessary to do their jobs
correctly.
Lastly, this standard requires the RNHCI to evaluate the
performance of the staff and implement measures for improvement as
needed. We assume that all staff, whether directly or indirectly
involved in patient care, will perform their duties competently and
efficiently and it is the RNHCI's responsibility to ensure that the
staff meet these expectations on an ongoing basis.
(g) Physical Environment (Sec. 403.742)
As with other providers, we expect an RNHCI to maintain a physical
environment that ensures the safety of the patients, staff, and the
public. We developed the physical environment standards based upon our
experiences with other providers participating in the Medicare or
Medicaid program. Section 403.742 consists of two standards, Buildings
and Patient rooms. We have set forth requirements that we believe are
fundamental to effective management of an RNHCI's physical environment.
The first standard, Buildings, requires that the condition of the
physical plant and the overall environment be developed and maintained
so that the safety and well-being of the patients are ensured. These
requirements state that there must be emergency power for emergency
lights and for fire detection, alarm, and extinguishing systems;
procedures for proper storage and disposal of trash; proper
ventilation, light, and temperature control throughout the RNHCI; a
written disaster plan to address loss of power, water, and sewage;
facilities for emergency gas and water supply; an effective pest
control program; a preventive maintenance program for essential
equipment; and a working call system for patients to summon aid or
assistance.
The second standard, Patient rooms, requires that all patient rooms
be designed and equipped for the adequate care, comfort and privacy of
the patient. We have designated that each room accommodate no more than
four patients and measure at least 80 square feet per patient if a
multiple patient room, and 100 square feet per patient for a single
patient room. We may permit variances in the standards relating to room
size on a case-by-case basis if these variances are intended for the
special needs of the patients and will not adversely affect the
patients' health or safety. Additionally, each room must have direct
access to an exit corridor, have at least one window to the outside,
and have a floor at or above grade level. Each room must be designed or
equipped to ensure full visual privacy for each patient.
The rest of the patient rooms standard concerns what furnishings
the RNHCI must provide each patient. The RNHCI is responsible for
furnishing a separate bed of the proper size and height outfitted with
a clean, comfortable mattress and bedding appropriate for the weather
and climate. Functional furniture appropriate for the patient's needs
must also be provided including individual closet space with clothes
racks and shelves that are accessible to the patient.
(h) Life Safety From Fire (Sec. 403.744)
The Life Safety Code, developed by the National Fire Protection
Association, serves as the basis for many Federal, State, and local
fire safety regulations. The Life Safety Code is a nationally
recognized standard that includes fire protection requirements
necessary to protect patients in health care facilities. The Life
Safety Code covers construction, fire protection, and occupancy
features needed to reduce danger to life from fire, smoke and fumes.
The code is applied to both new and existing buildings. The National
Fire Protection Association revises the code periodically to reflect
advancements in fire protection.
Under the condition we are requiring that an RNHCI comply with the
1997 edition of the Life Safety Code that we have incorporated by
reference. We are adopting the 1997 edition of the code because we
believe that it provides the highest available level of protection for
patients, staff and the public. The regulations also provide that we
may waive specific provisions of the code that would result in
unreasonable hardship upon an RNHCI, if the waiver does not adversely
affect patient health and safety. Additionally, the regulations permit
an RNHCI to meet a fire and safety code imposed by State law if HCFA
finds that the State imposed code adequately protects patients.
The balance of the condition requires that an RNHCI have written
fire control plans that contain provisions for prompt reporting of
fires; protection of patients, staff and the public; evacuation; and
cooperation with the fire fighting authorities. Other written evidence
must be maintained by the RNHCI that documents the regular inspection
and approval by the State or local fire agency.
(i) Utilization Review (Sec. 403.746)
Section 1861(ss)(1)(H) of the Act requires an RNHCI to have in
effect a utilization review plan. Each RNHCI must have in effect its
own utilization review plan, including the establishment of a
utilization review committee to carry out the functions of the program.
Under the first standard, we are requiring that the UR plan contain
written procedures for evaluating admissions, the duration of care, the
need for extended care, and the items and services furnished by the
RNHCI.
The second standard provides for the establishment of a UR
committee which will be responsible for all functions of the UR
program. We expect the utilization review committee to be responsible
for evaluating each admission to the facility to ensure that the
admission is necessary and appropriate. We are requiring that the
committee consist of the governing body, the administrator or other
individual responsible for the administration of the RNHCI, the nursing
supervisor, and other staff as
[[Page 67036]]
appropriate. The committee will evaluate the estimated duration of care
and, in the event of an extended stay, review the necessity and
appropriateness of the continued stay. We assume that the committee
will establish criteria and select norms to be used in determining the
necessity of admissions, extended stays and other services offered by
or in the facility as well as an ongoing review of these items. If the
committee cannot establish necessity or appropriateness of care, we
assume that the RNHCI will recommend that the patient's admission,
extended stay, or other services not be approved for payment.
Unlike other providers participating in the Medicare and Medicaid
programs, RNHCIs do not offer any medical treatments or procedures,
conventional or otherwise. Therefore, we do not believe it is
appropriate to prescribe a specific method or form for the utilization
review plan. While we have initially decided that allowing flexibility
for each RNHCI in the process of development and implementation of a
utilization review plan in a RNHCI will aid in more efficient and
appropriate delivery of services, we welcome comments on whether a more
prescriptive method should be required.
6. Estimate of Expenditures and Adjustments (Sec. 403.750)
Section 1821(c)(1) of the Act requires us to estimate the level of
Medicare expenditures for RNHCI benefits before the beginning of each
federal fiscal year (FFY) starting in FFY 2000. In addition, beginning
with FFY 1999, section 1821(c)(3) of the Act requires us to monitor the
expenditure level for RNHCI services provided in each FFY.
The estimation of expenditure levels is necessary to determine if
adjustments are required to limit payments to RNHCIs in the following
FFY. In addition, the estimate is used to determine if the sunset
provision is implemented.
The estimation of expenditures will take into consideration factors
that could impact on this budget projection. These factors include, but
are not limited, to projection of new facilities, the number of
beneficiaries making elections under this provision, trends in
discharges, length of stays, inflation, and other events that could
affect future expenditures. As required by section 1861(e) of the Act,
we will issue an annual Report to Congress, reviewed by OMB, as the
vehicle for reporting potential need to make adjustments in payments
and proposed mechanisms to be employed in order to stay within the
established expenditure trigger level.
The first objective of the yearly estimate is to determine if
payment adjustments are required during the FFY to prevent the level of
estimated expenditures from exceeding the ``trigger level.'' The
trigger level is defined in section 1821(c)(2)(C) of the Act as the
``unadjusted trigger level'' for an FFY increased or decreased by the
carry forward from the previous FFY. Section 1821(c)(2)(C)(ii)(I) of
the Act establishes the unadjusted trigger level at $20,000,000 for FFY
1998, which is also the trigger level for that year. To calculate each
succeeding unadjusted trigger level for an FFY, it is necessary to
adjust the unadjusted trigger level from the prior year by the average
percentage increase in the consumer price index for the 12-month period
ending with July preceding the beginning of the next FFY. To calculate
the trigger level for the current FFY, the unadjusted trigger level
(after being modified by the consumer price index for the current year)
is either increased or decreased by the carry forward from the previous
FFY; that is, by the amount by which expenditures for RNHCI services
either exceeded or fell short of the trigger level for that previous
FFY.
We believe that adhering to the terminology that appears in the
statute to explain the calculation of the trigger level might be
confusing because it requires an unadjusted trigger level to be
adjusted twice, once by the consumer price index and once by the carry
forward. Therefore, to help clarify our explanation of the calculation
of the trigger level, we use a new term to identify the unadjusted
trigger level from the prior FFY. The new term, ``base year amount,''
is the unadjusted trigger level from the previous FFY. To calculate the
unadjusted trigger level for the current FFY, the base year amount is
adjusted by the average consumer price index. This unadjusted trigger
level is then increased or decreased by the carry forward to compute
the trigger level for the current FFY.
To help explain the statutory provision, we have prepared the
following example.
Example (1). Trigger Level Calculation. This example shows the
calculation of the trigger level starting with FFY 1998. For FFY 1998,
the unadjusted trigger level and the trigger level are the same. The
initial unadjusted trigger level is established in the statute at
$20,000,000 for FFY 1998. For FFY 1999, the base year amount is the
unadjusted trigger level from the prior year, $20,000,000. The
unadjusted trigger level for 1999 is $20,700,000, which is the base
year amount ($20,000,000) increased by the multiplication of the base
year amount by the consumer price index of 3.5 percent ($20,000,000
times .035 = $700,000). For FFY 1999 the trigger level equals the
unadjusted trigger level since there is no carry forward. For FFY 2000,
the base year amount is $20,700,000, which is the unadjusted trigger
level from the prior year.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Unadjusted
Fiscal year Base year CPI trigger Trigger Actual outlays Carry forward
amount Level level
--------------------------------------------------------------------------------------------------------------------------------------------------------
Column 1 2 3 4 5* 6
1998.............................................................. $-0- N/A $20,000,000 $20,000,000 Not Required $-0 -
1999.............................................................. 20,000,000 3.5% 20,700,000 20,700,000 $8,500,000 12,200,000
2000.............................................................. 20,700,000 3.5% 21,424,500 33,624,500 16,000,000 17,624,500
2001.............................................................. 21,424,500 3.5% 22,174,358 39,798,858 20,000,000 19,798,858
2002.............................................................. 22,174,358 3.5% 22,950,460 42,749,318 30,000,000 12,749,318
2003.............................................................. 22,950,460 3.5% 23,753,726 36,503,044 40,000,000 (3,496,956)
2004.............................................................. 23,753,726 3.5% 24,585,107 21,088,151 25,000,000** (3,911,849)
2005.............................................................. 24,585,107 3.5% 25,445,585 21,533,736 25,000,000** (3,466,264)
2006.............................................................. 25,445,585 3.5% 26,336,180 22,869,916 25,000,000** (2,130,084)
2007.............................................................. 26,336,180 3.5% 27,257,946 25,127,862 27,000,000** (1,872,138)
--------------------------------------------------------------------------------------------------------------------------------------------------------
*Note: Column 5 actual outlays are for this example only and do not
represent a projection of expenditures. These numbers were created
solely for this example.
**Adjustments required by section 1861(c)(2) of the Act.
Calculations:
Column 1--Base Year = Prior Year Unadjusted Trigger.
[[Page 67037]]
Column 2--CPI = For simplicity, this example uses 3.5% for each
year.
Column 3--Unadjusted Trigger = Current base year times one plus the
result of the base year times the consumer price index.
FFY 2000--$21,424,500 = $20,700,000 x 1.035 (1+ .035).
Column 4--Trigger Level = Unadjusted triggers level for the current
fiscal year plus or minus the carry forward from the prior year.
FFY 2000--$33,624,500 = $21,424,500 + $12,200,000.
Column 6--Carry forward = Trigger level minus actual outlays.
FFY 2000--$17,624,500 = $33,624,500 - $16,000,000.
*Note: For FFY 2004 adjustments in payments would be imposed to
prevent estimated expenditures from exceeding the trigger level of
$21,088,151.
Example (2). Trigger Level Calculation--Carry Forward. This example
calculates the trigger level when the $50 million limitation on the
carry forward applies. For FFY 2003, the trigger level is $62,503,044
and actual outlays were $10 million. The difference is $52,503,044,
which is the potential carry forward to the next FFY. However, since
this difference is greater than $50 million, the carry forward used to
compute the trigger level for FFY 2004 is limited to $50 million. The
trigger level for FFY 2004 is $74,585,107, which is computed by adding
the unadjusted trigger level of $24,585,107 to the allowed carry
forward amount of $50 million.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Unadjusted
Fiscal year Base year CPI trigger Trigger Actual outlays Carry forward
amount level level
--------------------------------------------------------------------------------------------------------------------------------------------------------
Column 1 2 3 4 *5 6
1998.............................................................. $-0- N/A $20,000,000 $20,000,000 Not Required $-0 -
1999.............................................................. 20,000,000 3.5% 20,700,000 20,700,000 $8,500,000 12,200,000
2000.............................................................. 20,700,000 3.5% 21,424,500 33,624,500 10,000,000 23,624,500
2001.............................................................. 21,424,500 3.5% 22,174,358 45,798,858 15,000,000 30,798,858
2002.............................................................. 22,174,358 3.5% 22,950,460 53,749,318 15,000,000 38,749,318
2003.............................................................. 22,950,460 3.5% 23,753,726 62,503,044 10,000,000 **52,503,044
2004.............................................................. 23,753,726 3.5% 24,585,107 74,584,107 15,000,000 **59,585,107
2005.............................................................. 24,585,107 3.5% 25,445,585 75,445,585 20,000,000 **55,445,585
2006.............................................................. 25,445,585 3.5% 26,336,180 76,336,180 35,000,000 41,336,180
2007.............................................................. 26,336,180 3.5% 27,257,946 68,594,126 40,000,000 28,594,126
--------------------------------------------------------------------------------------------------------------------------------------------------------
*Note: Column 5 actual outlays are for this example only and do
not represent a projection of expenditures. These numbers were
created solely for this example.
** Carry forward limited to $50 million in computing subsequent
fiscal years trigger level.
Section 1821 (c)(2)(A) of the Act provides for a proportional
reduction in payments for covered RNHCI services when the level of
estimated expenditures exceeds the trigger level for any FFY. The
reduction is designed to prevent the level of estimated expenditures
from exceeding the trigger level for that FFY. However, if actual
expenditures surpass the trigger level then the trigger level for the
next FFY is decreased by the excess expenditures. Since the excess is a
negative carry forward adjustment, it reduces the trigger level for the
next FFY beginning with FFY 2004, as shown in Example 1.
In addition to a proportional reduction in payments, section
1821(c)(2)(B) of the Act authorizes us to impose other conditions or
limitations to keep Medicare expenditure levels below the trigger
level. The statute provides us with authority to decide which type of
adjustment to apply but is silent about when to apply a proportional
adjustment or when to apply alternative adjustments. Therefore, we have
extremely broad authority to decide what type of adjustments to impose.
The rule at Sec. 403.750 follows the statute and provides for
imposing either a proportional adjustment to payments or alternative
adjustments, depending on the magnitude of the adjustment required to
keep the level of estimated expenditures from exceeding the trigger
level. To account for any error in the estimation of expenditure
levels, the trigger level for the next FFY is adjusted by the carry
forward. If expenditures were to exceed the trigger level, the trigger
level for the subsequent year must be decreased, resulting in more
drastic payment adjustments in future years. We will do this in an
attempt to prevent expenditures from exceeding the trigger level for
three consecutive years and thus avoid having to implement the sunset
provision.
We decided not to list the possible alternative adjustments in the
rule. We considered establishing specific alternative adjustments in
the regulation but believed this would not provide the flexibility
needed to modify services and expenditures that section 1821(c)(2) of
the Act requires in a changing environment. If, in any new FFY, the
level of estimated expenditures were to exceed the trigger level, and
we believe that the proportional adjustment alone would be
inappropriate to reduce expenditures, we will consider making
alternative adjustments including but not limited to: (1) Not
certifying new facilities, (2) limiting Medicare payments to the number
of patient stays from the prior year, (3) limiting the days for which
Medicare would pay while a beneficiary was an inpatient, or (4)
limiting the number of new elections that could be filed for RNHCI
benefits. These alternative adjustments are only a few of the possible
adjustments that we will consider imposing. We will consider making
other adjustments depending on the magnitude of the adjustments
required to prevent estimated expenditures from exceeding the trigger
level. We will notify RNHCIs of the type or kind of adjustments that we
will impose in a given FFY. This notification will take place before
the start of the FFY in which the adjustments are to be effective.
7. Payment Provisions (Sec. 403.752)
(a) Payment to RNHCIs
Sections 1861(e) and (y)(1) of the Act grant us broad authority to
construct a payment methodology for RNHCIs. The Congressional committee
reports which accompanied this statutory provision reflected the intent
of the enactors that we continue to pay facilities likely to qualify
under this benefit on an interim basis until the regulations to
implement the statute were in place, and we have
[[Page 67038]]
done so. The only providers that could qualify as RNHCIs at the time of
enactment were Christian Science Sanatoria, and for that reason we
decided to continue to pay those facilities based on the methodology
under which they had previously been paid; that is, a reasonable cost
methodology. We have decided to continue to pay RNHCIs under a
reasonable cost methodology to insure a smooth transition to
prospective payment, as described below.
We currently regulate Christian Science sanatoria under the
regulations described in Secs. 412.90 and 412.98. These regulations
authorize payments to these facilities under the hospital prospective
payment system or, if the facility was excluded from the prospective
payment system, under reasonable cost principles. This final rule will
formally eliminate Sec. 412.90(c) and Sec. 412.98, and treat all RNHCIs
the same for payment purposes. We considered establishing different
payment methodologies for inpatient hospital services and post-hospital
extended care services furnished in RNHCIs, but have decided not to do
so. Since the nonmedical component of both inpatient hospital services
and post-hospital extended care services furnished in RNHCIs are
similar, and there are no differentiating medical components, we
believe it is appropriate to have one payment methodology for both
types of services.
We will pay RNHCIs under the same reasonable cost methodology we
have used for Christian Science sanatoria. Based on the historical data
available to us, Christian Science sanatoria have had average lengths
of stay exceeding 25 days, similar to long term care hospitals, and we
anticipate that this pattern will continue. The Christian Science
sanatoria have all qualified for exclusion from the hospital
prospective payment system on this basis. We will pay RNHCIs the
reasonable cost of furnishing covered services to Medicare
beneficiaries subject to the rate of increase limits in accordance with
the provisions in 42 CFR 413.40, which implement section 101 of the Tax
Equity and Fiscal Responsibility Act of 1982 (Public Law 97-248).
As will be the case for most types of providers after the
implementation of BBA'97, we eventually intend to pay all RNHCIs based
on a prospective payment methodology. We are planning to look
specifically at the SNF, home health, and rehabilitation hospital PPS
systems as models for payment system development. The SNF PPS is
resource-based and driven by an assessment instrument that captures
both resources and functional status. The home health and
rehabilitation hospital PPS also will be resource-based and driven by
assessment instruments and functional status. Thus, they appear to have
the features necessary to capture the resources needed to provide
religious nonmedical care. One key challenge is to identify a system
whose classification mechanism can be adapted to use the information
available in the RNHCI setting, i.e., functional status and resource
use but not diagnosis or other medical information. At this point, we
are not sure how that can be achieved fully in any of these settings.
The application of a prospective payment methodology is a multi-
step process, most of which is carried out by the fiscal intermediary.
That process would require the RNHCI to complete an assessment
instrument, for each beneficiary/patient on admission and at designated
intervals, excluding all identified medical elements contained in the
instrument. The assessment instrument is primarily geared to
identifying patient capabilities and the need for assistance with
activities of daily living and mobility. A completed copy of the
assessment instrument would be transmitted to the fiscal intermediary
to be read by computer and converted to a resource/payment
classification. This would afford an individual RNHCI the ability to
elect not to participate in the assessment instrument process for each
beneficiary with the understanding that it would result in the
automatic assignment of the minimum resource classification for payment
purposes.
We believe a prospective payment approach would be effective in
identifying RNHCI patient needs and appropriately paying for covered
services to meet beneficiaries' health care needs. Details on the SNF
prospective payment system were published in the Federal Register on
May 12, 1998 (63 FR 26252). BBA '97 outlines the requirements for
prospective payment systems to be developed for HHAs in section 4603
and for inpatient rehabilitation facilities in section 4421. Details on
the proposed HHA prospective payment system will be published in the
Federal Register in the near future. The proposed inpatient
rehabilitation facility prospective payment system is expected to be
published as a proposed rule in December of this year. We solicit the
views of interested entities regarding the development of a prospective
payment system for RNHCIs. We will consider these views in developing a
proposal to pay RNHCIs under a prospective payment methodology.
(b) Administrative and Judicial Review
Under section 1821(c)(2)(D) of the Act there is no administrative
or judicial review of our estimates of the level of expenditures for
RNHCI services or the application of the adjustment in payments for
those services. We are incorporating this provision into our
regulations.
(c) Beneficiary Liability
Under the new regulations, RNHCIs are subject to Medicare rules for
deductibles and coinsurance. Under normal Medicare rules, a provider of
services may only bill a beneficiary deductible and coinsurance
amounts. However, section 1821(c)(2)(E) authorizes RNHCIs to bill
individuals an amount equal to the reduction in payments applied under
sections 1821(c)(2) (A) or (B) of the Act.
Because the statute gives us authority to impose a wide variety of
alternative reductions, and because we are not specifying those
alternative adjustments in the rule, we also decided not to include in
the rule a formula for the computation of the amount of the Medicare
reduction. Establishing a set formula in regulations also would not
provide flexibility to compute the liability of a beneficiary if there
was a change in the way RNHCIs are paid later. Instead of limiting the
computation to a rigid set of rules, the regulations only state that
RNHCIs have the right to bill beneficiaries for the amount of the
Medicare reduction.
To inform beneficiaries of this liability, the regulations require
RNHCIs to inform each beneficiary in writing of any proportional
adjustment in effect at the time of their admission or any proportional
adjustment that may become effective during the beneficiary's Medicare-
covered length of stay. At least 30 days before the Medicare reduction
is to take effect, RNHCIs must give written notification to
beneficiaries who are already receiving care. The notification includes
an explanation that the law permits the RNHCI to bill beneficiaries the
amount of the allowed Medicare reduction. When the RNHCI bills the
beneficiary, the regulations require the RNHCI to furnish a calculation
of the Medicare reduction.
If we are required to reduce payments to RNHCIs for an FFY, we will
notify RNHCIs of the amount of the required payment reduction. This
notification will explain how RNHCIs will calculate the additional
amount that they may bill the beneficiaries.
Unless there is an unexpected growth in services furnished by
RNHCIs, we do
[[Page 67039]]
not anticipate the need to reduce payments in the near future. However,
we are using example 3 in section L below to show the potential effects
on the financial liability of a Medicare beneficiary. This example
assumes a proportional payment reduction of 12 percent to prevent the
level of estimated expenditures from exceeding the trigger level.
Because payments are required to be reduced by 12 percent (in this
example), the statute permits RNHCIs to bill beneficiaries the amount
of the Medicare reduction. To calculate the additional amount billable
to the beneficiary in this example we would instruct RNHCIs to use the
cost per diem from their most recently filed Medicare cost report
multiplied by the number of days included in the individual's Medicare
covered length of stay. This cost per discharge would then be reduced
by any coinsurance and deductible amounts billable to the individual
and any amounts billable to a third party payer. This net amount would
be multiplied by the proportional adjustment required for the FFY. The
result is the Medicare reduction amount that the RNHCI may bill the
beneficiary. If, in this example, the cost of furnishing a covered
inpatient service was $5,000 (25 days times $200 per day), the RNHCIs
could bill the individual an additional $508 ($5,000--$764 x 12%).
The $508 was computed by subtracting from the cost of the stay ($5,000)
a deductible of $764 and any coinsurance amount ($0 in this example)
times the proportional adjustment to payment of 12%. The RNHCI could
bill the individual $1,272, which consists of the deductible of $764
and the amount of the Medicare reduction attributable to the
beneficiary, $508.
8. Monitoring Expenditure Level (Sec. 403.754)
Section 1821(c)(3)(A) of the Act requires us to monitor the
expenditure level of RNHCIs beginning with FFY 1999. The regulation
follows the requirements of the statute and requires us to track actual
Medicare expenditures for services furnished in RNHCIs. The purpose of
monitoring Medicare expenditure levels is to calculate the carry
forward adjustment to the trigger level required by Sec. 403.750(d).
The carry forward adjustment is defined in section 1821(c)(3)(B)(I)
of the Act and is the difference between actual expenditures and the
trigger level for the prior FFY. When the level of Medicare
expenditures for an FFY exceeds or is less than the trigger level for
that FFY, then the trigger level for the next FFY will be reduced or
increased by the amount of the excess or deficit in expenditures.
However, the carry forward may not exceed $50 million for any FFY, in
accordance with section 1861(c)(3)(B)(ii) of the Act.
9. Sunset Provision (Sec. 403.756)
Section 1821(d) of the Act contains the RNHCI sunset provision.
This provision, when activated, will prevent beneficiaries from making
elections to receive Medicare payment for religious nonmedical health
care services after a certain date. The sunset provision will be
activated when the level of estimated expenditures exceeds the trigger
level for three consecutive FFYs, beginning in FFY 2002. Under the
sunset provision, only those individuals with a valid election in
effect before January 1 following the end of the third consecutive FFY
in which expenditures exceed the trigger level can have benefits paid
under part 403, subpart G. After that date, we will not accept any
elections to pay for services furnished in RNHCIs. The earliest the
sunset provision could become effective is January 1, 2005. Under this
scenario, only Medicare beneficiaries with a valid election in effect
before January 1, 2005, could have religious nonmedical health care
benefits paid by Medicare, and payment could be made only for RNHCI
services provided during those elections.
We will publish a notice in the Federal Register at least 60 days
before the effective date of the sunset provision to alert the public
that no elections will be accepted for services in an RNHCI.
The following example shows when adjustments are made and when the
sunset provision is activated.
Example (3). This example compares the trigger level to the level
of estimated expenditures to determine if adjustment in payments or
alternative adjustments are required. In addition, it tracks the
trigger level and the level of estimated expenditures to determine if
the sunset provision is activated. For the sunset provision to become
effective, estimated expenditures must exceed the trigger level for
three consecutive FFYs. In FFY 2001, this example presumes that
estimated expenditures for Medicare would exceed the trigger level. To
prevent estimated expenditures from exceeding the trigger level, we
would need to adjust payments to RNHCIs in the next FFY. This example
also assumes that estimated expenditures starting in FFY 2003 will
exceed the trigger level for three consecutive FFYs. In this
circumstance, the sunset provision would be activated, and, therefore,
no elections would be accepted after December 31, 2005. Individuals
with elections in effect on or before December 31, 2005, would continue
to have benefits paid under this provision for services provided for
the duration of those elections.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fiscal Year Trigger Level Estimated Expenditures Adjustments in Payments
--------------------------------------------------------------------------------------------------------------------------------------------------------
Column 1 2 3
1998................................. 20,000,000
1999................................. 20,700,000
2000................................. 33,624,500 20,000,000 NONE REQUIRED.
2001................................. 39,798,858 45,000,000 REDUCE PAYMENTS.
2002................................. 42,749,318 40,000,000 NONE REQUIRED.
2003................................. 36,503,044 45,000,000 (1 yr.) REDUCE PAYMENTS.
2004................................. 21,088,151 30,000,000 (2 yr.) REDUCE PAYMENTS.
2005................................. 21,533,736 25,000,000 (3 yr.) REDUCE PAYMENTS.
2006................................. 22,869,916 28,000,000 REDUCE PAYMENTS.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: Expenditures in this table are an example only and do not
represent projection of expenditures. These numbers were created
solely for this example.
B. Medicaid Provisions (Sec. 440.170)
Services in RNHCIs are optional Medicaid services that a State may
elect to include in its title XIX State plan in accordance with section
1905(a)(22) of the Act. This section permits the inclusion of any other
medical care and any other type of remedial care and any other type of
remedial care recognized under State law, specified by HCFA. Federal
financial participation is only
[[Page 67040]]
available to a State for these services if they are included in the
State Plan.
Prior to passage of the Balanced Budget Act of 1997, the Medicaid
program reimbursed for services provided in Christian Science
sanitoria, or by Christian Science nurses. The Social Security Act
exempted Christian Science sanitoria from the requirements of section
1902(a)(9)(A)(State responsibility for establishing and maintaining
health standards for private or public institutions in which recipients
of Medicaid may receive care or services), 1902(a)(31)(requirements for
plans of care, on-site inspections and evaluations of care by
professional, independent review teams and subsequent reporting to the
State agency by these teams concerning patients receiving care in
intermediate care facilities for the mentally retarded) and 1902(a)(33)
of the Act (condition of participation reviews). The statute also
exempted Christian Science sanitoria from the utilization review
requirements of section 1903(I)(4) of the Act and from the requirements
applicable to the licensing of nursing home administrators specified in
section 1908(e)(1) of the Act.
The Balanced Budget Act amended these sections of the statute to
delete the references to Christian Science sanitoria and to substitute
references to RNHCIs, as defined in section 1861(ss)(1) of the Act. We
are incorporating these revisions into the regulations. Consequently,
there is no longer authority for inclusion of Christian Science
sanitoria as a coverage category in Medicaid regulations. Section
4454(b) of the BBA'97 now provides for coverage of a religious
nonmedical health care institution as defined in section 1861(ss)(1) of
the Act. Specific ownership and affiliation requirements related to
RNHCIs are described in section 1861(ss)(4). We are therefore removing
Sec. 440.170(c), Services in Christian Science sanitoriums.
Additionally, a RNHCI as defined in section 1861(ss)(1) of the Act
furnishes exclusively inpatient services. Consequently, we are removing
Sec. 440.170(b), Services of Christian Science nurses, since it deals
with care in the home setting. These sections are being replaced with a
new Sec. 440.170(b), which defines a RNHCI for Medicaid coverage
purposes as one which meets the requirements of section 1861(ss)(1) of
the Act, and a new Sec. 440.170(c), which describes the specific
ownership and affiliation requirements applicable to Medicaid RNHCIs.
In order to be eligible to bill the Medicaid program, we are
requiring that a RNHCI meet the Medicare conditions of participation
described in part 403 of this rule. Section 4454(b) of the BBA'97
provides for Medicaid coverage of RNHCIs as defined in section
1861(ss)(1). Section 1861(ss)(1)(J) requires that a RNHCI meet such
other requirements as the Secretary finds necessary in the interest of
the health and safety of individuals who are furnished services in the
institution. This statutory requirement is implemented for the Medicare
program by the conditions of participation, which set quality and
safety standards for RNHCIs. We believe that Congress' intent in
incorporating section 1861(ss)(1)(J) in the Medicaid definition of a
RNHCI was to ensure the inclusion of similar health and safety
requirements in the Medicaid regulations. Based on our experience with
Christian Science sanitoria, we expect that the majority of RNHCIs
which will serve Medicaid beneficiaries will also serve Medicare
beneficiaries.
Therefore, rather than developing separate Medicaid requirements,
we are specifying that RNHCIs must meet the Medicare conditions of
participation in order to receive Medicaid reimbursement.
C. Part 488 Survey, Certification and Enforcement Procedures
Section 1861(ss)(2) provides that we may accept the accreditation
of an approved group that RNHCIs meet or exceed some or all of the
applicable Medicare requirements. Therefore, we are amending the
regulations at Sec. 488.2 to add section 1861(ss)(2) as the statutory
basis for accreditation of RNHCIs and Sec. 488.6 to add the RNHCIs to
the list of providers in this section.
D. Part 489--Provider Agreements and Supplier Approval
Technical Change
Section 4641 of the Balanced Budget Act of 1997 requires that
the patient's advance directive be placed in a ``prominent part'' of
his or her medical record. Therefore, we are adding ``prominent
part'' to Sec. 489.102(a)(2) to reflect this requirement; that is,
providers are required to ``Document in a prominent part of the
individual's current medical record * * * an advance directive.''
IV. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995 (PRA), agencies are
required to provide a 60-day notice in the Federal Register and solicit
public comment before a collection of information requirement is
submitted to the OMB for review and approval. In order to fairly
evaluate whether an information collection should be approved by OMB,
section 3506(c)(2)(A) of the PRA requires that we solicit comment on
the following issues:
Whether the information collection is necessary and useful
to carry out the proper functions of the agency;
The accuracy of the agency's estimate of the information
collection burden;
The quality, utility, and clarity of the information to be
collected; and
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
We are, however, requesting an emergency review of this interim
final rule with comment period. In compliance with section
3506(c)(2)(A) of the PRA, we are submitting to OMB the following
requirements for emergency review. We are requesting an emergency
review because the collection of this information is needed before the
expiration of the normal time limits under OMB's regulations at 5 CFR
part 1320, to ensure compliance with section 4454 of BBA'97. This
section requires that a Medicare beneficiary (or his or her legal
representative) who is entering, or who is already in, an RNHCI file an
election statement 30 days after the publication of this rule in order
to meet the requirements of the rule. We cannot reasonably comply with
normal clearance procedures because public harm is likely to result if
the agency cannot enforce the requirements of this section 4454 of
BBA'97 in order to ensure that the Medicare beneficiary receives
covered services in an RNHCI.
HCFA is requesting OMB review and approval of this collection 11
working days after the publication of this rule, with a 180-day
approval period. Written comments and recommendations will be accepted
from the public if received by the individuals designated below within
10 working days after the publication of this rule.
During this 180-day period, we will publish a separate Federal
Register notice announcing the initiation of an extensive 60-day agency
review and public comment period on these requirements. We will submit
the requirements for OMB review and an extension of this emergency
approval.
We are soliciting public comment on each of the issues for the
provisions summarized below that contain information collection
requirements:
Section 403.724 Valid Election Requirements
In summary, Sec. 403.724(a)(1) requires an RNHCI to utilize a
written election statement that includes the requirements set forth in
this section.
[[Page 67041]]
The burden associated with this requirement is the one-time effort
required to agree on the format for the election statement. It is
estimated that it will take each RNHCI 2 hours to comply with these
requirements. There are currently 19 Christian Science sanatoria
participating in Medicare that are expected to apply as RNHCIs; thus,
there will be a total of 38 burden hours. The burden associated with
signing, filing and submitting the election statement is described in
Secs. 403.724(a)(2)and(3) and 403.724(a)(4).
In summary, Sec. 403.724(a)(2) and (3) require that an election
must be signed and dated by the beneficiary or his or her legal
representative and have it notarized.
The burden associated with this requirement is the time required
for the beneficiary or his or her legal representative to read, sign,
and date the election statement and have it notarized. It is estimated
that it will take each beneficiary approximately 10 minutes to read,
sign, and date the election statement. We anticipate that the RNHCI
will have a notary present to witness and notarize the election
statement. There are approximately 1,000 beneficiaries that will be
affected by this requirement for a total of 167 burden hours during the
first year.
Section 403.724(a)(4) requires that the RNHCI keep a copy of the
election statement on file and submit the original to HCFA with any
information obtained regarding prior elections or revocations.
The burden associated with this requirement is the time required
for an RNHCI to keep a copy of the election statement and submit the
original to HCFA. It is estimated that it will take 5 minutes to comply
with this requirement. During the first year there will be
approximately 1,000 election statements for a total of 84 burden hours.
If not revoked, an election is effective for life and does not need
to be completed during future admissions. Section 403.724(b)(1) states
that a beneficiary can revoke his or her election statement by the
receipt of nonaccepted medical treatment or the beneficiary may
voluntarily revoke the election and notify HCFA in writing. We
anticipate that there would be very few (fewer than 10 beneficiaries)
if any instances in which a beneficiary will notify HCFA in writing
that he or she will revoke his or her election statement. We believe
the above requirement is not subject to the PRA in accordance with 5
CFR 1320.3(c)(4) since this requirement does not collect information
from ten or more entities on an annual basis.
Section 403.730 Condition of Participation: Patient Rights
Section 403.730(a)(1) states that the RNHCI must inform each
patient of his or her rights in advance of furnishing patient care.
The burden associated with this requirement is the time and effort
necessary to disclose the notice requirements referenced above to each
patient. We estimate that on average it will take each of the 19
estimated RNHCIs 8 hours to develop the required notice and that it
will take each RNHCI 5 minutes to provide each notice, with an average
of 109 notices provided per RNHCI on an annual basis. Therefore, the
total annual burden associated with this requirement is 173 hours after
the first year. For the first year there will be an additional one-time
burden of 152 hours.
In its resolution of the grievance, a RNHCI must provide the
patient with written notice of its decision that contains the name of
the RNHCI contact person, the process of the facility in resolving the
grievance, and contact information for appropriate State and Federal
resources.
The burden associated with this requirement is the time and effort
necessary to disclose the written notice to each patient who filed a
grievance. We estimate that on average it will take each RNHCI 15
minutes to develop and disseminate the required notice. We further
estimate that 19 RNHCIs will provide 5 notices on an annual basis, a
total annual burden of 1.5 hours, with an additional one-time burden of
5 hours the first year.
Section 403.736 Condition of Participation: Discharge Planning
While the information collection requirement (ICR) summarized below
is subject to the PRA, we believe the burden associated with this ICR
is exempt as defined in 5 CFR 1320.3(b)(2) because the time, effort,
and financial resources necessary to comply with the requirement would
be incurred by persons in the normal course of their activities.
Section 403.736(a)(1) requires that the discharge planning
evaluation must be initiated at admission and must include the
following: (1) An assessment of the possibility of a patient needing
post-RNHCI services and of the availability of those services and (2)
an assessment of the probability of a patient's capacity for self-care
or of the possibility of the patient being cared for in the environment
from which he or she entered the RNHCI.
Section 403.736(a)(3) states that the discharge planning evaluation
must be included in the patient's rights record for use in establishing
an appropriate discharge plan and must discuss the results of the
evaluation with the patient or a legal representative acting on his or
her behalf.
Section 403.736(b)(1) states that, if the discharge planning
evaluation indicates a need for a discharge plan, qualified and
experienced personnel must develop or supervise the development of the
plan.
Section 403.736(b)(2) states that, in the absence of a finding by
the RNHCI that the beneficiary needs a discharge plan, the beneficiary
or his or her legal representative may request a discharge plan. In
this case, the RNHCI must develop a discharge plan for the beneficiary.
Section 403.736(b)(3) states that the RNHCI must arrange for the
initial implementation of the patient's discharge plan.
Section 403.736(b)(4) states that, if there are factors that may
affect continuing care needs or the appropriateness of the discharge
plan, the RNHCI must reevaluate the beneficiary's discharge plan.
Section 403.736(b)(5) states that the RNHCI must inform the
beneficiary or legal representative about the beneficiary's post-RNHCI
care requirements.
Section 403.736(b)(6) states that the discharge plan must inform
the beneficiary or his or her legal representative about the freedom to
choose among providers of care when a variety of providers is available
that are willing to respect the discharge preferences of the
beneficiary or legal representative.
Section 403.736(c) states that the RNHCI must transfer or refer
patients to appropriate facilities (including medical facilities if the
beneficiary so desires) as needed for follow up or ancillary care and
notify the patient of his or her right to participate in planning the
transfer or referral in accordance with Sec. 403.730(a)(2).
Section 403.736(d) states that the RNHCI must reassess its
discharge planning process on an ongoing basis. The reassessment must
include a review of discharge plans to ensure that they are responsive
to discharge needs.
Section 403.738 Condition of Participation: Administration
While the information collection requirement (ICR) summarized below
is subject to the PRA, we believe the
[[Page 67042]]
burden associated with this ICR is exempt as defined in 5 CFR
1320.3(b)(2) because the time, effort, and financial resources
necessary to comply with the requirement would be incurred by persons
in the normal course of their activities.
Section 403.738(a) states that an RNHCI must have written policies
regarding its organization, services, and administration.
While the following ICR is an information collection requirement,
we believe the ICR is exempt from the PRA as defined in 5 CFR
1320.3(c)(4), since it does not collect information from 10 or more
entities on an annual basis.
Section 403.738(c)(4) states that the RNHCI must furnish written
notice, including the identity of each new individual or company, to
HCFA at the time of a change, if a change occurs in any of the
following: persons with an ownership or control interest, as defined in
42 CFR 420.201 and 455.101; the officers, directors, agents, or
managing employees; the religious entity, corporation, association, or
other company responsible for the management of the RNHCI; and the
RNHCI's administrator or director of nonmedical nursing services.
Section 403.742 Condition of Participation: Physical Environment
While the information collection requirement (ICR) summarized below
is subject to the PRA, we believe the burden associated with this ICR
is exempt as defined in 5 CFR 1320.3(b)(2) because the time, effort,
and financial resources necessary to comply with the requirement would
be incurred by persons in the normal course of their activities.
Section 403.742(a)(4) requires that a RNHCI have a written disaster
plan to address loss of power, water, sewage disposal, and other
emergencies.
Section 403.744 Condition of Participation: Life Safety From Fire
While the information collection requirement (ICR) summarized below
is subject to the PRA, we believe the burden associated with this ICR
is exempt as defined in 5 CFR 1320.3(b)(2) because the time, effort,
and financial resources necessary to comply with the requirement would
be incurred by persons in the normal course of their activities.
Section 403.744(a)(2) states that the RNHCI must have written fire
control plans that contain provisions for prompt reporting of fires;
extinguishing fires; protection of patients, staff and the public;
evacuation; and cooperation with fire fighting authorities.
Section 403.744(a)(3) states that the RNHCI must maintain written
evidence of regular inspection and approval by State or local fire
control agencies.
Section 403.746 Condition of Participation: Utilization Review
In summary, Sec. 403.746 states that the RNHCI must have in effect
a written utilization review plan to assess the necessity of services
furnished. The plan must provide that records be maintained of all
meetings, decisions, and actions by the utilization review committee.
The utilization review plan must contain written procedures for
evaluating the following: admissions, the duration of care, continuing
care of an extended duration, and items and services furnished.
Drafting a utilization review plan will take each current RNHCI 3
hours, for a total one time burden of 57 hours. Though we have received
no inquiries from any entity about becoming a RNHCI, for purposes of
this paperwork collection requirement, we estimate that there will be
one additional RNHCI each year, which will create a 3 hour burden
annually.
Section 403.752 Payment Provisions
The following section describes the burden associated with the
payment provisions and is subject to the PRA.
Based on the most recent data available, Medicare expenditures for
Christian Science sanatoria were approximately $8 million annually. The
trigger level for FFY 1998, the first year of RNHCI implementation, is
$20 million. Beginning in FFY 2000, when estimated expenditures for
RNHCI services exceed the trigger level for a FFY, HCFA must adjust the
RNHCI payment rates.
However, because of the amount of the gap between current
expenditures and the trigger level, and because we do not anticipate
that the number of RNHCIs will increase significantly, we do not
anticipate having to adjust the payment rates for a minimum of 3 years.
Thus, the section will not be implemented and there will be no
paperwork burden associated with it for several years. Therefore, there
is no burden associated with the following section at this time.
Section 403.752(d)(I) states that the RNHCI must notify the
beneficiary in writing at the time of admission of any proposed or
current proportional Medicare adjustment. A beneficiary currently
receiving care in the RNHCI must be notified in writing 30 days before
the Medicare reduction is to take effect. The notification must inform
the beneficiary that the RNHCI can bill him or her for the proportional
Medicare adjustment.
Section 403.752(d)(ii) states that the RNHCI must, at time of
billing, provide the beneficiary with his or her liability for payment,
based on a calculation of the Medicare reduction pertaining to the
beneficiary's covered services permitted by Sec. 403.750(b).
Section 440.170 General Provisions--Medicaid
We believe the following paperwork burden is not subject to the
Act, as defined by 5 CFR 1320.4(a)(2), since the collection action is
conducted during an investigation or audit against specific individuals
or entities.
Section 440.170(b)(9) states that an RNHCI must provide information
HCFA may require, upon request, to implement section 1821 of the Act,
including information relating to quality of care coverage and
determinations.
Section 489.102 Requirements for Providers
The ICR in the following section, except for its application to
RNHCIs, has been approved under OMB approval number 0938-0610.
In summary, Sec. 489.102(a) requires that hospitals, critical
access hospitals, skilled nursing facilities, home health agencies,
providers of home health care (and for Medicaid purposes, providers of
personal care services), hospices, and religious nonmedical health care
institutions document and maintain written policies and procedures
concerning advance directives with respect to all adult individuals
receiving medical care.
For the current approval, we stated that it will take each facility
3 minutes to document a beneficiary's record whether he or she has
implemented an advance directive. We anticipate that it will also take
each RNHCI 3 minutes per patient to comply with this requirement, for a
total of 104 burden hours on an annual basis. In addition, there will
be a one-time burden of 8 hours per RNHCI to maintain written policies
and procedures concerning advance directives, for a total of 152 hours.
We will submit a revision to OMB Approval Number 0938-610 to
reflect the addition of RNHCIs to the paperwork burden.
We have submitted a copy of this rule to OMB for its review of the
ICRs. These requirements are not effective until they have been
approved by OMB. A notice will be published in the Federal Register
when approval is obtained.
If you comment on any of these information collection and record
[[Page 67043]]
keeping requirements, please mail copies directly to the following:
Health Care Financing Administration, Office of Information Services,
Security and Standards Group, Division of HCFA Enterprise Standards,
Room N2-14-26, 7500 Security Boulevard, Baltimore, MD 21244-1850, Attn:
Julie Brown HCFA-1909-IFC, Fax number: (410) 786-0262 and,
Office of Information and Regulatory Affairs, Office of Management and
Budget, Room 10235, New Executive Office Building, Washington, DC
20503.
V. Regulatory Impact Analysis
We have examined the impacts of this rule as required by Executive
Order 12866 and the Regulatory Flexibility Act (RFA) (Public Law 96-
354). Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects, distributive impacts, and equity). A regulatory impact
analysis (RIA) must be prepared for major rules with economically
significant effects ($100 million or more annually).
The RFA requires agencies to analyze options for regulatory relief
of small businesses. For purposes of the RFA, small entities include
small businesses, nonprofit organizations and government agencies. Most
hospitals and most other providers and suppliers are small entities,
either by nonprofit status or by having revenues of $5 million or less
annually. Individuals and States are not included in the definition of
a small entity.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 604 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a Metropolitan
Statistical Area and has fewer than 50 beds.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule that may result in an annual expenditure by State,
local, or tribal governments, in the aggregate, or by the private
sector, of $100 million.
In accordance with the provisions of Executive Order 13132, this
regulation will not significantly affect the States beyond what is
required by basic State Plans for Medicaid. It follows the intent and
letter of the law and does not usurp State authority beyond the basic
Medicaid requirements. This regulation describes only processes that
must be undertaken if a State exercises its option to amend the State
plan to include coverage of inpatient religious nonmedical health care
institutions (RNHCIs) as set forth in section 4454 of the BBA'97.
Those States that have RNHCI facilities and have selected to offer
the optional RNHCI service are very limited. At the moment we only have
18 facilities participating in Medicare and four in Medicaid. The
monitoring of the program is conducted by staff in the Boston Regional
Office (Region I) and they will be responsible for the survey and
certification activity that is usually conducted by the State Agency.
Section 4454 of the BBA'97 amended the Act to remove the
authorization for payment for services furnished in Christian Science
sanatoria from both Medicare and Medicaid law. Section 4454 authorizes
payment for inpatient services in a RNHCI for beneficiaries who, for
religious reasons, are conscientiously opposed to the acceptance of
medical care. Section 4454 of BBA'97 provides for coverage of the
nonmedical aspects of inpatient care services in RNHCIs under Medicare
and as a State option under Medicaid. In order for a provider to
satisfy the definition of a religious nonmedical health care
institution, for both Medicare and Medicaid, it must satisfy the ten
qualifying provisions contained in new section 1861(ss)(1) of the Act.
The RNHCI choosing to participate in Medicare must also be in
compliance with both the conditions for coverage and the conditions of
participation contained in the new regulation. Neither Medicare nor
Medicaid will pay for any religious aspects of care provided in these
facilities. HCFA has used one fiscal intermediary to handle all
Christian Science sanatoria and the Boston Regional Office to monitor
the process, and we plan to continue that arrangement for RNHCIs.
Currently, there are 19 Christian Science sanatoria that are
furnishing services and receiving payment under Medicare. Three of
these facilities are dually eligible to participate in Medicare and
Medicaid, and there are two that only participate in Medicaid. Medicare
expenditure levels for Christian Science sanatoria has been
approximately $8 million annually.
We anticipate that most if not all existing Christian Science
sanatoria will be certified as RNHCIs but do not know how many other
facilities will be eligible to apply for participation. Therefore, we
cannot project the impact this regulation will have on payments or the
number of organizations that will elect to furnish services to what we
believe is a very small beneficiary population.
Section 4454 of BBA'97 establishes certain controls on the amount
of expenditures for RNHCI services in a given FFY. Section
1821(c)(2)(C) explains the operation of these controls through the use
of a trigger level. The trigger level for FFY 1998 is $20 million.
Thereafter, this amount is increased each FFY by the average consumer
price index. This amount is further increased or decreased by a carry
forward amount, which is the difference between the previous FFY's
expenditures and the previous FFY's trigger level.
The trigger level is used to determine if Medicare payments for the
current FFY need to be adjusted. Beginning with fiscal year 2000, if
the estimated level of expenditures for a FFY exceeds the trigger level
for that FFY, we are required by law to make a proportional adjustment
to payments or alternative adjustments to prevent expenditures from
exceeding the trigger level.
BBA'97 precludes administrative or judicial review of adjustments
that we determine are necessary to control expenditures. The trigger
level is also used to activate the sunset provision, which prohibits us
from accepting any new elections when estimated expenditures exceed the
trigger level for three consecutive fiscal years.
Since the Congress has established controls over the amount of
money that can be spent for RNHCI services and because Christian
Science sanatoria that qualify as RNHCIs will continue to be paid on a
reasonable cost basis, there should be no adverse impact on
beneficiaries or on existing facilities within the next five years
unless there is a dramatic increase in the number of RNHCIs and their
Medicare/Medicaid patients.
For these reasons, we are not preparing analyses for either the RFA
or section 1102(b) of the Act. We have determined, and we certify, that
this rule will not have a significant economic impact on a substantial
number of small entities or a significant impact on the operations of a
substantial number of small rural hospitals.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
[[Page 67044]]
IV. Regulatory Impact Statement
Consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
through 612), we prepare a regulatory flexibility analysis unless we
certify that a rule will not have a significant economic impact on a
substantial number of small entities. For purposes of the RFA, all
health care providers are considered to be small entities. Individuals
and States are not included in the definition of a small entity.
Section 1102(b) of the Act requires us to prepare a regulatory
impact analysis if a rule may have a significant impact on the
operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 604 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a Metropolitan
Statistical Area and has fewer than 50 beds.
Section 4454 of the BBA'97 amended the Act to remove the
authorization for payment for services furnished in Christian Science
sanatoria from both Medicare and Medicaid law. Section 4454 authorizes
payment for inpatient services in a RNHCI for beneficiaries who, for
religious reasons, are conscientiously opposed to the acceptance of
medical care. Section 4454 of BBA'97 provides for coverage of the
nonmedical aspects of inpatient care services in RNHCIs under Medicare
and as a State option under Medicaid. In order for a provider to
satisfy the definition of a religious nonmedical health care
institution, for both Medicare and Medicaid, it must satisfy the ten
qualifying provisions contained in new section 1861(ss)(1) of the Act.
The RNHCI choosing to participate in Medicare must also be in
compliance with both the conditions for coverage and the conditions of
participation contained in the new regulation. Neither Medicare nor
Medicaid will pay for any religious aspects of care provided in these
facilities. HCFA has used one fiscal intermediary to handle all
Christian Science sanatoria and the Boston Regional Office to monitor
the process, and we plan to continue that arrangement for RNHCIs.
Currently, there are 19 Christian Science sanatoria that are
furnishing services and receiving payment under Medicare. Three of
these facilities are dually eligible to participate in Medicare and
Medicaid, and there are two that only participate in Medicaid. Medicare
expenditure levels for Christian Science sanatoria has been
approximately $8 million annually.
We anticipate that most if not all existing Christian Science
sanatoria will be certified as RNHCIs but do not know how many other
facilities will be eligible to apply for participation. Therefore, we
cannot project the impact this regulation will have on payments or the
number of organizations that will elect to furnish services to what we
believe is a very small beneficiary population.
Section 4454 of BBA'97 establishes certain controls on the amount
of expenditures for RNHCI services in a given FFY. Section
1821(c)(2)(C) explains the operation of these controls through the use
of a trigger level. The trigger level for FFY 1998 is $20 million.
Thereafter, this amount is increased each FFY by the average consumer
price index. This amount is further increased or decreased by a carry
forward amount, which is the difference between the previous FFY's
expenditures and the previous FFY's trigger level.
The trigger level is used to determine if Medicare payments for the
current FFY need to be adjusted. Beginning with fiscal year 2000, if
the estimated level of expenditures for a FFY exceeds the trigger level
for that FFY, we are required by law to make a proportional adjustment
to payments or alternative adjustments to prevent expenditures from
exceeding the trigger level.
BBA'97 precludes administrative or judicial review of adjustments
that we determine are necessary to control expenditures. The trigger
level is also used to activate the sunset provision, which prohibits us
from accepting any new elections when estimated expenditures exceed the
trigger level for three consecutive fiscal years.
Since the Congress has established controls over the amount of
money that can be spent for RNHCI services and because Christian
Science sanatoria that qualify as RNHCIs will continue to be paid on a
reasonable cost basis, there should be no adverse impact on
beneficiaries or on existing facilities within the next five years
unless there is a dramatic increase in the number of RNHCIs and their
Medicare/Medicaid patients.
For these reasons, we are not preparing analyses for either the RFA
or section 1102(b) of the Act because we have determined, and we
certify, that this rule will not have a significant economic impact on
a substantial number of small entities or a significant impact on the
operations of a substantial number of small rural hospitals.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
V. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995 (PRA), agencies are
required to provide a 60-day notice in the Federal Register and solicit
public comment before a collection of information requirement is
submitted to the OMB for review and approval. In order to fairly
evaluate whether an information collection should be approved by OMB,
section 3506(c)(2)(A) of the PRA requires that we solicit comment on
the following issues:
Whether the information collection is necessary and useful
to carry out the proper functions of the agency;
The accuracy of the agency's estimate of the information
collection burden;
The quality, utility, and clarity of the information to be
collected; and
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
We are, however, requesting an emergency review of this interim
final rule with comment period. In compliance with section
3506(c)(2)(A) of the PRA, we are submitting to OMB the following
requirements for emergency review. We are requesting an emergency
review because the collection of this information is needed before the
expiration of the normal time limits under OMB's regulations at 5 CFR
part 1320, to ensure compliance with section 4454 of BBA'97. This
section requires that a Medicare beneficiary (or his or her legal
representative) who is entering, or who is already in, an RNHCI file an
election statement 30 days after the publication of this rule in order
to meet the requirements of the rule. We cannot reasonably comply with
normal clearance procedures because public harm is likely to result if
the agency cannot enforce the requirements of this section 4454 of
BBA'97 in order to ensure that the Medicare beneficiary receives
covered services in an RNHCI.
HCFA is requesting OMB review and approval of this collection 11
working days after the publication of this rule, with a 180-day
approval period. Written comments and recommendations will be accepted
from the public if received by the individuals designated below within
10 working days after the publication of this rule.
During this 180-day period, we will publish a separate Federal
Register notice announcing the initiation of an extensive 60-day agency
review and public comment period on these requirements. We will submit
the requirements for OMB review and an extension of this emergency
approval.
[[Page 67045]]
We are soliciting public comment on each of the issues for the
provisions summarized below that contain information collection
requirements:
Section 403.724 Valid Election Requirements
In summary, Sec. 403.724(a)(1) requires an RNHCI to utilize a
written election statement that includes the requirements set forth in
this section.
The burden associated with this requirement is the one-time effort
required to agree on the format for the election statement. It is
estimated that it will take each RNHCI 2 hours to comply with these
requirements. There are currently 19 Christian Science sanatoria
participating in Medicare that are expected to apply as RNHCIs; thus,
there will be a total of 38 burden hours. The burden associated with
signing, filing and submitting the election statement is described in
Secs. 403.724(a) (2) and (3) and 403.724(a)(4).
In summary, Sec. 403.724(a)(2) and (3) require that an election
must be signed and dated by the beneficiary or his or her legal
representative and have it notarized.
The burden associated with this requirement is the time required
for the beneficiary or his or her legal representative to read, sign,
and date the election statement and have it notarized. It is estimated
that it will take each beneficiary approximately 10 minutes to read,
sign, and date the election statement. We anticipate that the RNHCI
will have a notary present to witness and notarize the election
statement. There are approximately 1,000 beneficiaries that will be
affected by this requirement for a total of 167 burden hours during the
first year.
Section 403.724(a)(4) requires that the RNHCI keep a copy of the
election statement on file and submit the original to HCFA with any
information obtained regarding prior elections or revocations.
The burden associated with this requirement is the time required
for an RNHCI to keep a copy of the election statement and submit the
original to HCFA. It is estimated that it will take 5 minutes to comply
with this requirement. During the first year there will be
approximately 1,000 election statements for a total of 84 burden hours.
If not revoked, an election is effective for life and does not need
to be completed during future admissions. Section 403.724(b)(1) states
that a beneficiary can revoke his or her election statement by the
receipt of nonexcepted medical treatment or the beneficiary may
voluntarily revoke the election and notify HCFA in writing. We
anticipate that there would be very few (fewer than 10 beneficiaries)
if any instances in which a beneficiary will notify HCFA in writing
that he or she will revoke his or her election statement. We believe
the above requirement is not subject to the PRA in accordance with 5
CFR 1320.3(c)(4) since this requirement does not collect information
from ten or more entities on an annual basis.
While the information collection requirements (ICR) summarized
below are subject to the PRA, we believe the burden associated with
these ICRs is exempt as defined in 5 CFR 1320.3(b)(2) because the time,
effort, and financial resources necessary to comply with these
requirements would be incurred by persons in the normal course of their
activities.
Section 403.730 Condition of Participation: Patient Rights
Section 403.730(a)(1) states that the RNHCI must inform each
patient of his or her rights in advance of furnishing patient care.
Section 403.732 Condition of participation: Quality Assessment and
Evaluation
In summary, Sec. 403.732 states that the RNHCI must develop,
implement, and maintain a quality assessment and evaluation program.
Section 403.736 Condition of Participation: Discharge Planning
Section 403.736(a)(1) requires that the discharge planning
evaluation must be initiated at admission and must include the
following: (1) an assessment of the possibility of a patient needing
post-RNHCI services and of the availability of those services and (2)
an assessment of the probability of a patient's capacity for self-care
or of the possibility of the patient being cared for in the environment
from which he or she entered the RNHCI.
Section 403.736(a)(3) states that the discharge planning evaluation
must be included in the patient's rights record for use in establishing
an appropriate discharge plan and must discuss the results of the
evaluation with the patient or a legal representative acting on his or
her behalf.
Section 403.736(b)(1) states that, if the discharge planning
evaluation indicates a need for a discharge plan, qualified and
experienced personnel must develop or supervise the development of the
plan.
Section 403.736(b)(2) states that, in the absence of a finding by
the RNHCI that the beneficiary needs a discharge plan, the beneficiary
or his or her legal representative may request a discharge plan. In
this case, the RNHCI must develop a discharge plan for the beneficiary.
Section 403.736(b)(3) states that the RNHCI must arrange for the
initial implementation of the patient's discharge plan.
Section 403.736(b)(4) states that, if there are factors that may
affect continuing care needs or the appropriateness of the discharge
plan, the RNHCI must reevaluate the beneficiary's discharge plan.
Section 403.736(b)(5) states that the RNHCI must inform the
beneficiary or legal representative about the beneficiary's post-RNHCI
care requirements.
Section 403.736(b)(6) states that the discharge plan must inform
the beneficiary or his or her legal representative about the freedom to
choose among providers of care when a variety of providers is available
that are willing to respect the discharge preferences of the
beneficiary or legal representative.
Section 403.736(c) states that the RNHCI must transfer or refer
patients to appropriate facilities (including medical facilities if the
beneficiary so desires) as needed for follow up or ancillary care and
notify the patient of his or her right to participate in planning the
transfer or referral in accordance with Sec. 403.730(a)(2).
Section 403.736(d) states that the RNHCI must reassess its
discharge planning process on an ongoing basis. The reassessment must
include a review of discharge plans to ensure that they are responsive
to discharge needs.
Section 403.738 Condition of Participation: Administration
In summary Sec. 403.738 states that an RNHCI must have written
policies regarding its organization, services, and administration.
Section 403.742 Condition of Participation: Physical Environment
Section 403.742(a)(4) requires that a RNHCI have a written disaster
plan to address loss of power, water, sewage disposal, and other
emergencies.
Section 403.744 Condition of Participation: Life Safety From Fire
Section 403.744(a)(2) states that the RNHCI must have written fire
control plans that contain provisions for prompt reporting of fires;
extinguishing fires; protection of patients, staff and the public;
evacuation; and cooperation with fire fighting authorities.
Section 403.744(a)(3) states that the RNHCI must maintain written
evidence
[[Page 67046]]
of regular inspection and approval by State or local fire control
agencies.
Section 403.746 Condition of Participation: Utilization Review
In summary, Sec. 403.746 states that the RNHCI must have in effect
a written utilization review plan to assess the necessity of services
furnished. The plan must provide that records be maintained of all
meetings, decisions, and actions by the utilization review committee.
The utilization review plan must contain written procedures for
evaluating the following: admissions, the duration of care, continuing
care of an extended duration, and items and services furnished.
Section 489.102 Requirements for Providers
In summary, Sec. 489.102(a) requires that hospitals, critical
access hospitals, skilled nursing facilities, home health agencies,
providers of home health care (and for Medicaid purposes, providers of
personal care services), hospices, and religious nonmedical health care
institutions document and maintain written policies and procedures
concerning advance directives with respect to all adult individuals
receiving medical care.
While the following ICR is subject to the PRA, we believe the
burden associated with this ICR is exempt as defined in 5 CFR
1320.3(c)(4), since it does not collect information from 10 or more
entities on an annual basis.
Section 403.738 Condition of Participation: Administration
Section 403.738(c)(4) states that the RNHCI must furnish written
notice, including the identity of each new individual or company, to
HCFA at the time of a change, if a change occurs in any of the
following: persons with an ownership or control interest, as defined in
42 CFR 420.201 and 455.101; the officers, directors, agents, or
managing employees; the religious entity, corporation, association, or
other company responsible for the management of the RNHCI; and the
RNHCI's administrator or director of nonmedical nursing services.
The following sections describe the burden associated with the
payment provisions. Based on the most recent data available, Medicare
expenditures for Christian Science sanatoria were approximately $8
million annually. The trigger level for FFY 1998, the first year of
RNHCI implementation, is $20 million. Beginning in FFY 2000, when
estimated expenditures for RNHCI services exceed the trigger level for
a FFY, HCFA must adjust the RNHCI payment rates. Therefore, the burden
associated with the following sections is not subject to the PRA at
this point in time.
Section 403.752 Payment provisions
Section 403.752(d)(i) states that the RNHCI must notify the
beneficiary in writing at the time of admission of any proposed or
current proportional Medicare adjustment. A beneficiary currently
receiving care in the RNHCI must be notified in writing 30 days before
the Medicare reduction is to take effect. The notification must inform
the beneficiary that the RNHCI can bill him or her for the proportional
Medicare adjustment.
Section 403.752(d)(ii) states that the RNHCI must, at time of
billing, provide the beneficiary with his or her liability for payment,
based on a calculation of the Medicare reduction pertaining to the
beneficiary's covered services permitted by Sec. 403.750(b).
We believe the following ICR is not subject to the Act, as defined
by 5 CFR 1320.4(a)(2), since the collection action is conducted during
an investigation or audit against specific individuals or entities.
Section 440.170 General Provisions--Medicaid
Section 440.170(b)(9) states that an RNHCI must provide information
HCFA may require, upon request, to implement section 1821 of the Act,
including information relating to quality of care coverage and
determinations.
PRA Summary of Burden
The table below indicates the annual number of responses for each
regulation section in this rule containing ICRs, the average burden per
response in minutes or hours, and the total annual burden hours.
Estimated Annual Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
CFR section Responses Average burden per response Burden hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
403.724(a)(1)....................... 19....................................... 2 hours.................................. 38 hours.
403.724(a)(2)(3).................... 1,000.................................... 10 minutes............................... 167 hours.
403.724(a)(4)....................... 1,000.................................... 5 minutes................................ 84 hours.
Total......................... ......................................... ......................................... 289 hours.
--------------------------------------------------------------------------------------------------------------------------------------------------------
We have submitted a copy of this rule to OMB for its review of the
ICRs. These requirements are not effective until they have been
approved by OMB. A notice will be published in the Federal Register
when approval is obtained.
If you comment on any of these information collection and record
keeping requirements, please mail copies directly to the following:
Health Care Financing Administration, Office of Information Services,
Security and Standards Group, Division of HCFA Enterprise Standards,
Room N2-14-26, 7500 Security Boulevard, Baltimore, MD 21244-1850, Attn:
Louis Blank HCFA-1909-IFC, Fax number: (410) 786-0262 and,
Office of Information and Regulatory Affairs, Office of Management and
Budget, Room 10235, New Executive Office Building, Washington, DC
20503, Attn.: Allison Herron Eydt, HCFA Desk Officer, Fax numbers:
(202) 395-6974 or (202) 395-5167
VI. Waiver of Proposed Rulemaking
We ordinarily publish a notice of proposed rulemaking in the
Federal Register and invite prior public comment on proposed rules. The
notice of proposed rulemaking includes a reference to the legal
authority under which the rule is proposed, and the terms and
substances of the proposed rule or a description of the subjects and
issues involved. This procedure can be waived, however, if an agency
finds good cause that a notice-and-comment procedure is impracticable,
unnecessary, or contrary to the public interest and incorporates a
statement of the finding and its reasons in the rule issued.
Section 4454 of BBA'97 requires us to publish this rule in final
with a comment period and bypass the normal notice-and-comment period.
Therefore, we find good cause to waive the notice of proposed
rulemaking and to issue this final rule on an interim basis. We are
providing a
[[Page 67047]]
60-day comment period for public comment.
VII. Response to Comments
Because of the large number of items of correspondence we normally
receive on Federal Register documents published for comment, we are not
able to acknowledge or respond to them individually. We will consider
all comments we receive 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
42 CFR Part 403
Health insurance, Hospitals, Incorporation by refrence,
Intergovernmental relations, Medicare, Reporting and recordkeeping
requirements.
42 CFR Part 412
Administrative practice and procedure, Health facilities, Medicare,
Puerto Rico, Reporting and recordkeeping requirements.
42 CFR Part 431
Grant programs-health, Health facilities, Medicaid, Privacy,
Reporting and recordkeeping requirements.
42 CFR Part 440
Grant programs-health, Medicaid.
42 CFR Part 442
Grant programs-health, Health facilities, Health professions,
Medicaid, Nursing homes, Reporting and recordkeeping requirements.
42 CFR Part 456
Administrative practice and procedure, Grant programs-health,
Health facilities, Medicaid, Reporting and recordkeeping requirements.
42 CFR Part 466
Grant programs-health, Health facilities, Reporting and
recordkeeping requirements.
42 CFR Part 488
Health facilities, Medicare, Reporting and recordkeeping
requirements.
42 CFR Part 489
Health facilities, Medicare, Reporting and recordkeeping
requirements.
Accordingly, 42 CFR chapter IV is amended as follows:
PART 403--SPECIAL PROGRAMS AND PROJECTS
1. The authority citation for part 403 continues to read as
follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
2. Subpart F is added and reserved.
3. Subpart G is added to read as follows:
Subpart G--Religious Nonmedical Health Care Institutions--Benefits,
Conditions of Participation, and Payment
Sec.
403.700 Basis and purpose.
403.702 Definitions and terms.
403.720 Conditions for coverage.
403.724 Valid election requirements.
403.730 Condition of participation: Patient rights.
403.732 Condition of participation: Quality assessment and
performance improvement.
403.734 Condition of participation: Food services.
403.736 Condition of participation: Discharge planning.
403.738 Condition of participation: Administration.
403.740 Condition of participation: Staffing.
403.742 Condition of participation: Physical environment.
403.744 Condition of participation: Life safety from fire.
403.746 Condition of participation: Utilization review.
403.750 Estimate of expenditures and adjustments.
403.752 Payment provisions.
403.754 Monitoring expenditure level.
403.756 Sunset provision.
Subpart G--Religious Nonmedical Health Care Institutions--Benefits,
Conditions of Participation, and Payment
Sec. 403.700 Basis and purpose.
This subpart implements sections 1821; 1861(e),(y), and (ss); 1869;
and 1878 of the Act regarding Medicare payment for inpatient hospital
or posthospital extended care services furnished to eligible
beneficiaries in religious nonmedical health care institutions.
Sec. 403.702 Definitions and terms.
For purposes of this subpart, the following definitions and terms
apply:
Election means a written statement signed by the beneficiary or the
beneficiary's legal representative indicating the beneficiary's choice
to receive nonmedical care or treatment for religious reasons.
Excepted medical care means medical care that is received
involuntarily or required under Federal, State, or local laws.
FFY stands for Federal fiscal year.
Medical care or treatment means health care furnished by or under
the direction of a licensed physician that can involve diagnosing,
treating, or preventing disease and other damage to the mind and body.
It may involve the use of pharmaceuticals, diet, exercise, surgical
intervention, and technical procedures.
Nonexcepted medical care means medical care (other than excepted
medical care) that is sought by or for a beneficiary who has elected
religious nonmedical health care institution services.
Religious nonmedical care or religious method of healing means
health care furnished under established religious tenets that prohibit
conventional or unconventional medical care for the treatment of a
beneficiary, and the sole reliance on these religious tenets to fulfill
a beneficiary's total health care needs.
RNHCI stands for ``religious nonmedical health care institution,''
as defined in section 1861(ss)(1) of the Act.
Religious nonmedical nursing personnel means individuals who are
grounded in the religious beliefs of the RNHCI, trained and experienced
in the principles of nonmedical care, and formally recognized as
competent in the administration of care within their religious
nonmedical health care group.
Sec. 403.720 Conditions for coverage.
Medicare covers services furnished in an RNHCI if the following
conditions are met:
(a) The provider meets the definition of an RNHCI as defined in
section 1861(ss)(1) of the Act. That is, it is an institution that:
(1) Is described in section 501(c)(3) of the Internal Revenue Code
of 1986 and is exempt from taxes under section 501(a).
(2) Is lawfully operated under all applicable Federal, State, and
local laws and regulations.
(3) Furnishes only nonmedical nursing items and services to
beneficiaries who choose to rely solely upon a religious method of
healing and for whom the acceptance of medical services would be
inconsistent with their religious beliefs.
(4) Furnishes nonmedical items and services exclusively through
nonmedical nursing personnel who are experienced in caring for the
physical needs of nonmedical patients.
(5) Furnishes nonmedical items and services to inpatients on a 24-
hour basis.
(6) Does not furnish, on the basis of religious beliefs, through
its personnel or otherwise medical items and services
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(including any medical screening, examination, diagnosis, prognosis,
treatment, or the administration of drugs) for its patients.
(7) Is not owned by, is not under common ownership with, or does
not have an ownership interest of 5 percent or more in, a provider of
medical treatment or services and is not affiliated with a provider of
medical treatment or services or with an individual who has an
ownership interest of 5 percent or more in, a provider of medical
treatment or services. (Permissible affiliations are described at
Sec. 403.738(c).)
(8) Has in effect a utilization review plan that sets forth the
following:
(i) Provides for review of the admissions to the institution, the
duration of stays, and the need for continuous extended duration of
stays in the institution, and the items and services furnished by the
institution.
(ii) Requires that reviews be made by an appropriate committee of
the institution that included the individuals responsible for overall
administration and for supervision of nursing personnel at the
institution.
(iii) Provides that records be maintained of the meetings,
decisions, and actions of the review committee.
(iv) Meets other requirements as the Secretary finds necessary to
establish an effective utilization review plan.
(9) Provides information HCFA may require to implement section 1821
of the Act, including information relating to quality of care and
coverage decisions.
(10) Meets other requirements HCFA finds necessary in the interest
of the health and safety of the patients who receive services in the
institution. These requirements are the conditions of participation in
this subpart.
(b) The provider meets the conditions of participation cited in
Secs. 403.730 through 403.746. (A provider may be deemed to meet
conditions of participation in accordance with part 488 of this
chapter.)
(c) The provider has a valid provider agreement as a hospital with
HCFA in accordance with part 489 of this chapter and for payment
purposes is classified as an extended care hospital.
(d) The beneficiary has a condition that would make him or her
eligible to receive services covered under Medicare Part A as an
inpatient in a hospital or SNF.
(e) The beneficiary has a valid election as described in
Sec. 403.724 in effect for Medicare covered services furnished in an
RNHCI.
Sec. 403.724 Valid election requirements.
(a) General requirements. An election statement must be made by the
Medicare beneficiary or his or her legal representative.
(1) The election must be a written statement that must include the
following statements:
(i) The beneficiary is conscientiously opposed to acceptance of
nonexcepted medical treatment.
(ii) The beneficiary acknowledges that the acceptance of
nonexcepted medical treatment is inconsistent with his or her sincere
religious beliefs.
(iii) The beneficiary acknowledges that the receipt of nonexcepted
medical treatment constitutes a revocation of the election and may
limit further receipt of services in an RNHCI.
(iv) The beneficiary acknowledges that the election may be revoked
by submitting a written statement to HCFA.
(v) The beneficiary acknowledges that revocation of the election
will not prevent or delay access to medical services available under
Medicare Part A in facilities other than RNHCIs.
(2) The election must be signed and dated by the beneficiary or his
or her legal representative.
(3) The election must be notarized.
(4) The RNHCI must keep a copy of the election statement on file
and submit the original to HCFA with any information obtained regarding
prior elections or revocations.
(5) The election becomes effective on the date it is signed.
(6) The election remains in effect until revoked.
(b) Revocation of election. (1) A beneficiary's election is revoked
by one of the following:
(i) The beneficiary receives nonexcepted medical treatment for
which Medicare payment is requested.
(ii) The beneficiary voluntarily revokes the election and notifies
HCFA in writing.
(2) The receipt of excepted medical treatment as defined in
Sec. 403.702 does not revoke the election made by a beneficiary.
(c) Limitation on subsequent elections. (1) If a beneficiary's
election has been made and revoked twice, the following limitations on
subsequent elections apply:
(i) The third election is not effective until 1 year after the date
of the most recent revocation.
(ii) Any succeeding elections are not effective until 5 years after
the date of the most recent revocation.
(2) HCFA will not accept as the basis for payment of any claim any
elections executed on or after January 1 of the calendar year in which
the sunset provision described in Sec. 403.756 becomes effective.
Sec. 403.730 Condition of participation: Patient rights.
An RNHCI must protect and promote each patient's rights.
(a) Standard: Notice of rights. The RNHCI must do the following:
(1) Inform each patient of his or her rights in advance of
furnishing patient care.
(2) Have a process for prompt resolution of grievances, including a
specific person within the facility whom a patient may contact to file
a grievance. In addition, the facility must provide patients with
information about the facility's process as well as with contact
information for appropriate State and Federal resources.
(b) Standard: Exercise of rights. The patient has the right to:
(1) Be informed of his or her rights and to participate in the
development and implementation of his or her plan of care.
(2) Make decisions regarding his or her care, including transfer
and discharge from the RNHCI. (See Sec. 403.736 for discharge and
transfer requirements.)
(3) Formulate advance directives and expect staff who furnish care
in the RNHCI to comply with those directives, in accordance with part
489, subpart I of this chapter. For purposes of conforming with the
requirement in Sec. 489.102 that there be documentation in the
patient's medical records concerning advanced directives, the patient
care records of a beneficiary in an RNHCI are equivalent to medical
records held by other providers.
(c) Standard: Privacy and safety. The patient has the right to the
following:
(1) Personal privacy.
(2) Care in a safe setting.
(3) Freedom from verbal, psychological, and physical abuse, and
misappropriation of property.
(4) Freedom from the use of restraints.
(5) Freedom from involuntary seclusion.
(d) Standard: Confidentiality of patient records. For any patient
care records or election information it maintains on patients, the
RNHCI must establish procedures to do the following:
(1) Safeguard the privacy of any information that identifies a
particular patient. Information from, or copies of, records may be
released only to authorized individuals, and the RNHCI must ensure that
unauthorized individuals cannot gain access to or alter patient
records. Original patient care records must be released only in
accordance with Federal or State laws, court orders, or subpoenas.
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(2) Maintain the records and information in an accurate and timely
manner.
(3) Ensure timely access by patients to the records and other
information that pertains to that patient.
(4) Abide by all Federal and State laws regarding confidentiality
and disclosure for patient care records and election information.
Sec. 403.732 Condition of participation: Quality assessment and
performance improvement.
The RNHCI must develop, implement, and maintain a quality
assessment and performance improvement program.
(a) Standard: Program scope. (1) The quality assessment and
performance improvement program must include, but is not limited to,
measures to evaluate:
(i) Access to care.
(ii) Patient satisfaction.
(iii) Staff performance.
(iv) Complaints and grievances.
(v) Discharge planning activities.
(vi) Safety issues, including physical environment.
(2) In each of the areas listed in paragraph (a)(1) of this
section, and any other areas the RNHCI includes, the RNHCI must do the
following:
(i) Define quality assessment and performance improvement measures.
(ii) Describe and outline quality assessment and performance
improvement activities appropriate for the services furnished by or in
the RNHCI.
(iii) Measure, analyze, and track performance that reflect care and
RNHCI processes.
(iv) Inform all patients, in writing, of the scope and
responsibilities of the quality assessment and performance improvement
program.
(3) The RNHCI must set priorities for performance improvement,
considering the prevalence of and severity of identified problems.
(4) The RNHCI must act to make performance improvements and must
track performance to assure that improvements are sustained.
(b) Standard: Program responsibilities. (1) The governing body,
administration, and staff are responsible for ensuring that the quality
assessment and performance improvement program addresses identified
priorities in the RNHCI and are responsible for the development,
implementation, maintenance, and performance improvement of assessment
actions.
(2) The RNHCI must include all programs, departments, functions,
and contracted services when developing, implementing, maintaining, and
evaluating the program of quality assessment and performance
improvement.
Sec. 403.734 Condition of participation: Food services.
The RNHCI must have an organized food service that is directed and
adequately staffed by qualified personnel.
(a) Standard: Sanitary conditions. The RNHCI must furnish food to
the patient that is obtained, stored, prepared, distributed, and served
under sanitary conditions.
(b) Standard: Meals. The RNHCI must serve meals that furnish each
patient with adequate nourishment in accordance with the recommended
dietary allowances of the Food and Nutrition Board of the National
Research Council, National Academy of Sciences. The RNHCI must do the
following:
(1) Furnish food that is palatable, attractive, and at the proper
temperature and consistency.
(2) Offer substitutes of similar nourishment to patients who refuse
food served or desire alternative choices.
(3) Furnish meals at regular times comparable to normal mealtimes
in the community. There must be no more than 14 hours between a
substantial evening meal and breakfast the following day.
(4) The RNHCI must offer snacks at bedtime.
Sec. 403.736 Condition of participation: Discharge planning.
The RNHCI must have in effect a discharge planning process that
applies to all patients. The process must assure that appropriate post-
institution services are obtained for each patient, as necessary.
(a) Standard: Discharge planning evaluation. (1) The RNHCI must
assess the need for a discharge plan for any patient identified as
likely to suffer adverse consequences if there is no planning and for
any other patient upon his or her request or at the request of his or
her legal representative. This discharge planning evaluation must be
initiated at admission and must include the following:
(i) An assessment of the possibility of a patient needing post-
RNHCI services and of the availability of those services.
(ii) An assessment of the probability of a patient's capacity for
self-care or of the possibility of the patient being cared for in the
environment from which he or she entered the RNHCI.
(2) The staff must complete the assessment on a timely basis so
that arrangements for post-RNHCI care are made before discharge and so
that unnecessary delays in discharge are avoided.
(3) The discharge planning evaluation must be included in the
patient's rights record for use in establishing an appropriate
discharge plan and must discuss the results of the evaluation with the
patient or a legal representative acting on his or her behalf.
(b) Standard: Discharge plan. (1) If the discharge planning
evaluation indicates a need for a discharge plan, qualified and
experienced personnel must develop or supervise the development of the
plan.
(2) In the absence of a finding by the RNHCI that the beneficiary
needs a discharge plan, the beneficiary or his or her legal
representative may request a discharge plan. In this case, the RNHCI
must develop a discharge plan for the beneficiary.
(3) The RNHCI must arrange for the initial implementation of the
beneficiary's discharge plan.
(4) If there are factors that may affect continuing care needs or
the appropriateness of the discharge plan, the RNHCI must reevaluate
the beneficiary's discharge plan.
(5) The RNHCI must inform the beneficiary or legal representative
about the beneficiary's post-RNHCI care requirements.
(6) The discharge plan must inform the beneficiary or his or her
legal representative about the freedom to choose among providers of
care when a variety of providers is available that are willing to
respect the discharge preferences of the beneficiary or legal
representative.
(c) Standard: Transfer or referral. The RNHCI must transfer or
refer patients in a timely manner to another facility (including a
medical facility if requested by the beneficiary, or his or her legal
representative) in accordance with Sec. 403.730(b)(2).
(d) Standard: Reassessment. The RNHCI must reassess its discharge
planning process on an ongoing basis. The reassessment must include a
review of discharge plans to ensure that they are responsive to
discharge needs.
Sec. 403.738 Condition of participation: Administration.
An RNHCI must have written policies regarding its organization,
services, and administration.
(a) Standard: Compliance with Federal, State, and local laws. The
RNHCI must operate in compliance with all applicable Federal, State,
and local laws, regulations, and codes including, but not limited to,
those pertaining to the following:
(1) Protection against discrimination on
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