[Federal Register Volume 65, Number 39 (Monday, February 28, 2000)]
[Proposed Rules]
[Pages 10450-10464]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-4389]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
42 CFR Parts 405 and 491
[HCFA-1910-P]
RIN 0938-AJ17
Medicare Program; Rural Health Clinics: Amendments to
Participation Requirements and Payment Provisions; and Establishment of
a Quality Assessment and Performance Improvement Program
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Proposed rule.
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SUMMARY: This proposed rule would amend our regulations to revise
certification and payment requirements for Rural Health Clinics (RHCs)
as required by the Balanced Budget Act of 1997 (BBA 1997). It would
include new refinements of what constitutes a qualifying rural shortage
area in which a Medicare RHC must be located; establish criteria for
identifying RHCs essential to delivery of primary care services that
can continue to be approved as Medicare RHCs in areas no longer
designated as medically underserved; and limit waivers of certain
nonphysician practitioner staffing requirements. It also would impose
payment limits on provider-based RHCs and prohibit ``commingling'' the
use of the space, equipment, and other resources of an
[[Page 10451]]
RHC with another entity. Finally, the rule would require RHCs to
establish a quality assessment and performance improvement program that
goes beyond current regulations.
This proposed rule would make other revisions for clarity and
uniformity and to improve program administration.
DATES: Comments will be considered if we receive them at the
appropriate address, as provided below, no later than 5 p.m. on April
28, 2000.
ADDRESSES: Mail written comments (1 original and 3 copies) to the
following address: Health Care Financing Administration, Department of
Health and Human Services, Attention: HCFA-1910-P, P.O. Box 26676,
Baltimore, MD 21207-0476.
If you prefer, you may deliver your written comments (1 original
and 3 copies) to one of the following addresses: Room 443-G, Hubert H.
Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201,
or Room C5-09-26, 7500 Security Boulevard, Baltimore, MD 21244-1850.
Comments may also be submitted electronically to the following e-
mail address: [email protected]. For e-mail comment procedures, see
the beginning of SUPPLEMENTARY INFORMATION. For further information on
ordering copies of the Federal Register containing this document and on
electronic access, see the beginning of SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: David Worgo, (410) 786-5919 or Mary
Collins (quality issues) (410) 786-3186.
SUPPLEMENTARY INFORMATION:
E-mail, Comments, Availability of Copies, and Electronic Access
E-mail comments must include the full name, postal address, and
affiliation (if applicable) of the sender and must be submitted to the
referenced address to be considered. All comments must be incorporated
in the e-mail message because we may not be able to access attachments.
Because of staffing and resource limitations, we cannot accept
comments by facsimile (FAX) transmission. In commenting, please refer
to file code HCFA-1910-P. Comments received timely will be available
for public inspection as they are received, generally beginning
approximately 3 weeks after publication of a document, in Room 443-G of
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Friday, except for Federal holidays.
I. Background
A. General
The Rural Health Clinic Services Act of 1977, Public Law 95-210,
enacted December 13, 1977, amended the Social Security Act (the Act) by
enacting section 1861(aa) to extend Medicare and Medicaid entitlement
and payment for primary and emergency care services furnished at a
rural health clinic (RHC) by physicians and certain nonphysician
practitioners, and for services and supplies incidental to their
services. ``Nonphysician practitioners'' included nurse practitioners
and physician assistants. (Subsequent legislation extended the
definition of covered RHC services to include the services of clinical
psychologists, clinical social workers, and certified nurse midwives).
According to House Report No. 95-548(I), the purpose of Public Law
95-210 was to address an inadequate supply of physicians to serve
Medicare beneficiaries and Medicaid recipients in rural areas. The
program addressed this problem by providing qualifying clinics located
in rural, medically underserved communities with Medicare beneficiaries
and Medicaid recipients with payment on a cost-related basis for
outpatient physician and certain nonphysician services. (The Medicare
payment provisions for rural health clinics are in sections 1833(a)(3)
and 1833(f) of the Act and in our regulations beginning at 42 CFR
405.2462.)
Qualifying clinics, among other criteria, had to be located in a
nonurbanized area as defined by the Census Bureau and in a medically
underserved area as designated by the Health Resources and Services
Administration or (since the Omnibus Budget Reconciliation Act of 1989,
section 6213(c)) the chief executive officer of the State. (See section
1861(aa)(2) of the Act, following subparagraph (K).) There are three
types of shortage area designations applicable to RHC qualification:
health professional shortage areas, medically underserved areas, and
governor-designated shortage areas. The clinic's service area must
have, in addition to being located in a nonurbanized area, one of these
shortage area designations if the clinic is to qualify to receive RHC
status.
Qualifying clinics also had to employ a physician assistant or
nurse practitioner and, to meet requirements of the Omnibus Budget
Reconciliation Act of 1989, had to have a nurse practitioner, a
physician assistant, or a certified nurse midwife available to furnish
patient care services at least 50 percent of the time the RHC operates.
Growth of RHCs in the Medicare Program
After a slow start, the program has recently grown at a rapid
rate--from less than 1,000 Medicare-approved RHCs in 1992 to more than
3,500 in early 1998. While part of this increase has improved access to
primary care services in rural areas for Medicare and Medicaid
beneficiaries, there are instances in which these additional RHCs have
not expanded access.
Continuing Participation
A significant factor in the growth of RHCs stems from the original
RHC legislation, which included a ``grandfather clause'' to promote the
development of RHCs. (Section 1(e) of Public Law 95-210, 42 U.S.C.
1395x
[[Page 10452]]
note. Also see Sec. 491.5(b)(2).) In addition, the third sentence of
section 1861(aa)(2) of the Act stated that:
A facility that is in operation and that qualifies as a rural
health clinic * * * [under the Medicare or Medicaid program] and
that subsequently fails to satisfy the requirements of clause (i)
[in the second sentence of section 1861(aa)(2), pertaining to the
rural and underserved location requirement], shall be considered * *
* as still satisfying the requirement of such clause.
This provision protected the clinic's RHC status despite any possible
changes to the rural or underserved status of its service area. It
allowed clinics to remain in the RHC program even though their service
areas were no longer considered rural or medically underserved.
The Congress established this protection to encourage clinics to
attract needed health care professionals to underserved rural areas and
to retain them without being concerned about losing the shortage area
designation, which would make the clinics ineligible for RHC status and
its reimbursement incentives. In other words, once the clinic
successfully attracted the needed health care professionals to the
area, the Congress wanted to ensure that the service area did not
return to its previous underserved status because we removed the
clinic's RHC status and reimbursement incentives.
Although the grandfather provision was based on justifiable policy
considerations, we are now confronted with RHC participation in some
service areas with extensive health care delivery systems where
Medicare and Medicaid beneficiaries are not having difficulty obtaining
primary care. Both the General Accounting Office and the Department of
Health and Human Services' Inspector General recommended the
establishment of a mechanism, under the survey and certification
process for Medicare facilities, to discontinue RHC status and its
payment incentives in those service areas where they are no longer
justified. (See the next paragraph.) In section 4205(d)(3) of the
Balanced Budget Act of 1997 (BBA) (Public Law 105-33), the Congress
responded to these recommendations by amending the grandfather
provision to provide protection only to clinics essential to the
delivery of primary care.
Government Reports
Both the General Accounting Office and the Department of Health and
Human Services' Inspector General concluded, based on recent studies,
that the number of RHCs is growing out of proportion to the need and
some RHCs remain in the program after the need for payment incentives
no longer exists. They also concluded that the payment methodology for
provider-based RHCs lacks sufficient cost controls and recommended
establishing payment limits and screens on reasonable costs for these
providers. (A provider-based RHC is an integral and subordinate part of
a Medicare-participating hospital, skilled nursing facility, or home
health agency, and is operated with other departments of the provider
under common licensure, governance, and professional supervision. All
other RHCs are considered to be independent.) For more information on
these reports see ``Rural Health Clinics: Rising Program Expenditures
Not Focused on Improving Care in Isolated Areas'' (GAO/HEHS-97-24,
November 22, 1996), and ``Rural Health Clinics: Growth, Access and
Payment'' (OEI-05-94-00040, July 1996).
Medically Underserved Designations
Another reason for the continued growth of the RHC program was that
two types of shortage area designations, specifically the Medically
Underserved Area (MUA) and Governor's designations, did not have a
statutory requirement for regular review and have not been
systematically reviewed and updated for some time. As a result, some
new RHCs may have been certified in areas that would no longer be
designated as underserved if reviewed with current data. In response,
as discussed below, the Congress amended the legislation by requiring
that only those clinics located in shortage areas that have been
recently designated or updated will qualify for purposes of the RHC
program.
Commingling
We define the term ``commingling'' to mean the simultaneous
operation of an RHC and another physician practice, thereby mixing the
two practices. The two practices share hours of operation, staff,
space, supplies, and other resources. Commingling occurs in RHCs that
are an integral part of another provider, such as a hospital, as well
as in RHCs that are independent.
Examples of Commingling. Industry sources have told us that many
providers combine provider-based RHCs and non-RHC emergency room staffs
and location to furnish services to beneficiaries seeking primary care,
emergency services, or both. In such situations, Medicare payment has
been made separately on a reasonable cost basis for hospital outpatient
department services and for the RHC services. Also, emergency room
physician services are payable according to the Part B physician fee
schedule.
We also understand that some providers use skeleton emergency room
staffs, routinely assign RHC staff members to the emergency room or
other parts of the provider, and bill the Medicare program not only for
full RHC costs, but also for non-RHC Part B benefits (hospital
outpatient department services and physician services). When these
situations occur, Medicare pays the RHC's administrative costs, which
include the costs for RHC staff salaries (including physician and
practitioner salaries) and for any Part B services performed by the RHC
staff, whether performed within the clinic setting or in other provider
departments. The provider receives two payments for the cost of
services furnished by a particular staff member who had simultaneous
assignments.
A common approach taken by independent RHCs is to operate a private
physician practice in the RHC at the same time the physician is
furnishing RHC services to patients. We believe this creates the
opportunity for incorrect bills or duplicate payments.
B. Legislation
Refinement of Shortage Area Requirements
Refinement of the shortage area requirements involves two phases.
1. Phase I. Paragraphs(d)(1) and (2) of section 4205 of the BBA
concern the requirements in the second sentence of section 1861(aa)(2)
of the Act that RHCs must be located in a nonurbanized area as defined
by the Bureau of the Census, as well as in a Health Professional
Shortage Area, a medically underserved area, or in a shortage area
designated by a State governor. The Congress amended those provisions
to state that the rural area must also be one in which there are
insufficient numbers of needed health care practitioners as determined
by the Department. The Congress also amended that sentence to specify
that, to be used in RHC certification, shortage area designations made
by the Department or by a State governor must have been made within the
previous 3-year period.
2. Phase II. In paragraph(d)(3)(A) of section 4205 of the BBA,
which amended the third sentence of section 1861(aa)(2) of the Act, the
Congress revised the ``grandfather clause'' that permitted an exception
to the termination of RHC status for a clinic located in an area that
that is no longer a rural area or a shortage area. This revision
amended the grandfather clause to specify that an exception is
available
[[Page 10453]]
only if the RHC is determined to be essential to the delivery of
primary care services that would otherwise be unavailable in the
geographic area served by the RHC. These amendments were made effective
upon issuance of implementing regulations that the Congress directed us
to issue by January 1, 1999.
Staffing Waiver
Section 4161(b)(2) of the Omnibus Budget Reconciliation Act of 1990
added section 1861(aa)(7) to the Act to provide us with the authority
to grant a 1-year waiver of the requirement that an RHC must employ a
physician assistant, nurse practitioner, or certified nurse midwife and
must furnish their services 50 percent of the time the RHC operates, if
the clinic can demonstrate that it has been unable, in the previous 90-
day period, to hire one of these nonphysician primary care providers.
In section 4205(c) of the BBA, the Congress amended, effective
January 1, 1998, section 1861(aa)(7)(B) of the Act to restrict further
our authority to waive the requirement that each RHC must hire a
physician assistant, nurse practitioner, or certified nurse midwife. A
waiver may now be granted only to a participating RHC. That is, the
waiver cannot be granted before the clinic has been determined by us to
meet all the requirements for Medicare participation as an RHC and is
actually participating as an RHC.
Payment Limits for Provider-Based RHCs
Before the BBA, the payment methodology for an RHC depended on
whether it was ``provider-based'' or ``independent.'' Payment to
provider-based RHCs for services furnished to Medicare beneficiaries
was made on a reasonable cost basis by the provider's fiscal
intermediary in accordance with our regulations at part 413. Payment to
independent RHCs for services furnished to Medicare beneficiaries was
made on the basis of a uniform all-inclusive rate payment methodology
in accordance with part 405, subpart X. Payment to independent RHCs was
also subject to a maximum payment per visit as set forth in section
1833(f) of the Act.
The BBA, at section 4205(a), amended section 1833(f) of the Act. It
now holds provider-based RHCs to the same payment limit and all-
inclusive payment methodology as independent RHCs. This provision also
provides an exception to the payment limit for those clinics based in
small rural hospitals with fewer than 50 beds.
Quality Assessment Program
Currently, quality of RHC care is addressed in Sec. 491.11, which
requires a clinic to evaluate its total program annually. The
evaluation must include reviewing the utilization of the clinic's
services, a representative sample of both active and closed clinical
records, and the clinic's health care policies. The purpose of the
evaluation is to determine whether the utilization of services was
appropriate, the established policies were followed, and any changes
are needed. The clinic's staff considers the findings of the evaluation
and takes the necessary corrective action. These requirements focus on
the meeting and documentation of the clinic's evaluation of its quality
care and do not account for the outcome of these activities. Section
4205(b) of the BBA amended section 1861(aa)(2)(I) of the Act to
authorize us to require that an RHC have a quality assessment and
performance improvement program. A quality assessment and performance
improvement program enables the organization to systematically review
its operating systems and processes of care to identify and implement
opportunities for improvement.
II. Provisions of This Proposed Rule
Definition of Shortage Area for RHC Certification
Section 6213 of OBRA 1989 amended 1861(aa)(2) of the Social
Security Act to expand the types of shortage areas eligible for RHC
certification. Until then, the eligible areas included only those
designated by the Secretary as areas having a shortage of personal
health services under section 330(b)(3) of the PHS Act (medically
underserved areas), and those designated as geographic health
professional shortage areas under section 332(a)(1)(A) of the PHS Act.
The OBRA 1989 amendment expanded the eligible areas to also include
high impact migrant areas designated under section 329(a)(5) of the PHS
Act; areas containing a population group HPSA designated under section
332(a)(1)(B) of the PHS Act; and areas designated by the Governor of a
State and certified by the Secretary as having a shortage of personal
health services. Later, however, the Health Centers Consolidation Act
of 1996 (Public Law 104-299) renumbered section 329 and repealed the
requirement for designation of high migrant impact areas. We would
amend section 491.2 to conform the regulations to the above statutory
changes, by defining shortage areas for RHC purposes to include all
four remaining types of designated areas.
Section 330(b)(3) of the PHS Act defines medically underserved
populations (MUPs) to include both areas and population groups
designated by the Secretary as having a shortage of personal health
services. However, Section 1861(aa)(2) of the Social Security Act
specifically limits eligibility for the rural health clinic program to
areas designated under this statute (known as medically underserved
areas, MUAs). Thus, a clinic located in an area which contains only a
population group designation under section 330(b)(3) is not eligible
for participation in the Medicare or Medicaid programs as an RHC.
Accordingly, our amendment of the regulation reflects inclusion of
medically underserved areas (MUAs) but exclusion of medically
underserved population groups (MUPs) for RHC certification.
Although the expansion of eligible areas by section 6213 of OBRA
1989 and the exclusion of population groups (MUPs) for RHC
certification have already been implemented by regional office and
State operation manuals, we need to conform the regulations.
A. Refinement of Shortage Area Requirements
As noted above, section 4205(d)(1) of the BBA amended the second
sentence of section 1861(aa)(2) of the Act to require the use of
shortage areas designated ``within the previous 3-year period.'' We
propose to implement this by amending Sec. 491.3(b) to refer to ``a
current shortage area whose designation has been made or updated within
the current year or the previous 3 years.''
Before the BBA, clinics entering the RHC program were required to
be located in a shortage area designated by the Health Resources and
Services Administration or by the State. If the clinic's service area
was on the Health Resources and Services Administration's or the
State's list of designated shortage areas, the clinic satisfied the
definition of shortage area for purposes of Medicare participation. Any
clinic now applying for Medicare participation as an RHC must be
located in a shortage area that has been so designated or updated
within the current year or 1 of the previous 3 calendar years.
Although these changes have already been implemented in a
memorandum to our regional offices on February 6, 1998, we need to
conform the regulations. Therefore, we would include the 3-year
provision in Sec. 491.3(b) to provide that all RHCs applying for
Medicare
[[Page 10454]]
participation must be located in a current shortage area in order to be
approved for participation in Medicare as an RHC.
Under the provisions of the BBA, existing RHCs whose locations no
longer meet rural and/or shortage area requirements must be
disqualified from further participation in the Medicare program as RHCs
unless they are deemed essential to the delivery of primary care that
would otherwise be unavailable in the geographic area served by the
clinic. Under these statutory requirements, we propose to establish, in
Secs. 491.3 and 491.5, the procedures and standards for granting an
exception to clinics essential to the delivery of primary care that
would otherwise be unavailable in the geographic area served by the
clinic.
Eligibility for an Exception
We would specify, in Sec. 491.3, that an RHC located in a rural
area that is no longer designated as medically underserved, is eligible
to apply for an exception. Those RHCs located in an area no longer
designated as a nonurbanized area as defined by the Census Bureau are
not eligible to apply for an exception.
We believe that to extend the grandfather provision to clinics in
nonrural areas through the exception process would be contrary to the
fundamental definition of an RHC as an entity located in a rural area.
Process. We would specify, in Sec. 491.3(c), the following
procedures for submitting an exception request:
In order to apply for an exception from the requirement
that it meets the criteria in section 1861(aa)(2)(I) of the Act, the
affected RHC must submit a request to its HCFA regional office for
review.
An RHC will have 90 days, from the date of notification
from HCFA that its location no longer meets the definition of shortage
area, to submit an exception request to the HCFA regional office.
The HCFA regional office will have authority to grant a 3-
year exemption to any RHC that it determines, under the criteria
discussed below, is essential to the delivery of primary care that
would otherwise be unavailable in the geographic area served by the
clinic. The 3-year exemption time period is consistent with the
shortage redetermination period of 3 years and would be
administratively easy to manage.
Termination of RHCs located in areas that lose their shortage area
designation. RHCs ineligible for an exception would be denied RHC
participation in the Medicare program 90 days following the initial
HCFA notification that its location no longer meets the definition of a
shortage area.
RHCs eligible to apply for an exception but unable to satisfy the
criteria for an exception would be denied RHC participation in the
Medicare program 90 days following the HCFA notification that its
application for an exception has been rejected. We are allowing this
period in part to permit the health care professionals of these clinics
time to arrange to receive payment from the Medicare carrier for their
services under other Medicare payment provisions for which they may
qualify. An RHC that does not request an exception will have its
Medicare participation as an RHC terminated 90 days following the
initial HCFA notification that its location no longer meets shortage
area requirements.
Criteria for Exception
We propose, in Sec. 491.5, to accord an exception to an existing
RHC that can satisfy one of the following tests:
Sole Community Provider. We are proposing to classify an existing
RHC as ``essential'' if it is the only Medicare or Medicaid primary
care provider within the service area. To determine whether it is the
only participating provider, we would apply a time and distance
standard that would be measured by a travel time greater than 30
minutes from the RHC applying for the exception to other Medicare and
Medicaid participating primary care providers. The standard that
primary care services should be available and accessible within 30
minutes travel time has been in use by Health Resources and Services
Administration programs, which deal extensively with primary care
providers and access to these services, since the 1970s. For purposes
of this test, primary care provider means an RHC, a Federally Qualified
Health Center (FQHC), or a physician practicing in either general
practice, family practice, or general internal medicine.
The following criteria could potentially be used in determining
distances corresponding to 30 minutes travel time: under normal
conditions with primary roads available--20 miles; in areas with only
secondary roads available--15 miles; in flat terrain or in areas
connected by interstate highways--30 miles.
The geographic test would address the principal reason the Congress
established the original grandfather provision: to ensure that the
service area does not return to its previous medically underserved
status because of the removal of the clinic's RHC status and
reimbursement incentives.
This test is being proposed because RHCs are currently the sole
providers for many underserved rural communities in this country that
could lose their status as underserved with the addition of one or two
health care professionals. When these RHCs' successful recruitment of
additional health care professionals results in a dedesignation of the
shortage area, we want to make sure that the RHC and its new
professionals remain in the service area as viable providers. Without
the clinic's presence in the community, the area could potentially
return to its medically underserved status. RHCs applying for an
exception under this test would be expected to demonstrate that they
accept Medicare (where applicable), Medicaid and uninsured patients
that present themselves for treatment.
Traditional Community Providers. We are also proposing to classify
an existing RHC as essential if it is the sole RHC for its community
and the only primary care provider that has traditionally served
Medicare, Medicaid, and uninsured patients in the community despite the
fact that there may be other primary care providers that have recently
begun participating within reasonable travel time of the RHC. We
believe it is necessary to accord these RHCs an exception if the recent
presence of other primary care provider(s) caused the shortage area to
lose its designation as underserved. In this situation, where the
recent presence of other primary care providers, such as one or two new
physician practices, in the service area triggered the shortage area
dedesignation. We believe such an area may be too unstable in terms of
access to primary care to warrant the removal the clinic's RHC status
and cost-based reimbursement. We believe this is particularly true if
the sole RHC has been serving its community for many years and has
accepted Medicare, Medicaid, and uninsured patients that presented
themselves for treatment.
However, if there are several primary care providers who have been
actively treating Medicare, Medicaid, and uninsured patients for a
number of years and these providers are within 30 minutes travel time
of the RHC, we believe the RHC should not be granted an exception as an
essential clinic because the service area would now appear to be
stable. For example, if the RHC's service area (30 minutes travel time)
has two or more participating primary care providers that have been
actively treating Medicare, Medicaid, and uninsured patients for a
minimum of 5 years, we would not grant the exception. Consequently, we
would
[[Page 10455]]
only accord an exception to sole RHCs that are actively treating
Medicare and Medicaid beneficiaries and the uninsured located in
unstable service areas as described above.
Major Community Provider. We are also proposing to classify an
existing RHC as essential if it is treating a disproportionate greater
share of the patients in its community compared to other RHCs that are
within 30 minutes travel time. We are proposing this test to address
the situation (as reported by the General Accounting Office, DHHS
Inspector General, and State Medicaid agencies) of RHC concentrations,
such as RHCs located next door to or across the street from each other.
Concentrations of RHCs have developed in a number of service areas
since 1990, and it is possible that some of these communities have
already lost or will lose their medically underserved designation. It
is also possible that no RHCs within the cluster would be able to
qualify for an exception, under the criteria described above. However,
within this group there may nonetheless be an ``essential'' RHC. To
address this situation, we are proposing this test to identify whether
there is a major community provider within a concentration of RHCs.
The premise behind this test is to grant an exception to an RHC
that is a major community provider to Medicare and Medicaid
beneficiaries and the uninsured in service areas where other RHCs do
not provide or limit services to these groups. Granting an exception to
a clinic under this test is not meant to be a routine occurrence. The
RHC applying for an exception would have to make a compelling case that
services it provides would be otherwise unavailable in the geographic
area served by the clinic.
Specialty Clinic Test. We are proposing to classify an existing RHC
as ``essential'' if it exclusively provides pediatric services or
obstetrical/gynecological (OB/GYN) services for its community.
The purpose of this test is to recognize RHCs that are providers of
pediatric or OB/GYN health care for their communities. In general,
clinics applying for an exception are in jeopardy of losing RHC status
because their service areas are no longer designated as medically
underserved, which means there is an adequate supply of health care
professionals within the community. Although the local delivery system
may consist of several primary care practitioners, it may be that the
RHC is the only provider furnishing pediatric or OB/GYN care for the
community. If the specialty clinic(s) cannot remain financially viable,
the community could be left without any OB/GYN or pediatric services.
Therefore, in rural communities where these services are limited
despite an otherwise adequate supply of health care professionals, we
would classify the specialty clinic as essential to the delivery of
primary care and grant it an exception. RHCs applying for an exception
under this test would be expected to demonstrate that they accept
Medicare (where applicable), Medicaid, and uninsured patients that
present themselves for treatment.
Graduate Medical Education (GME) Test. We are proposing to classify
an existing RHC as ``essential'' if it is actively participating in an
accredited GME program. We would accord an exception to any RHC located
in a rural area that is part of a medical residency training program
approved by the Accreditation Council for Graduate Medical Education of
the American Medical Association.
Under section 4625 of the BBA, the Congress specifically recognized
RHCs as qualified non-hospital providers for GME payments, to encourage
more training of future physicians in non-hospital settings. Without
RHC status, rural clinics that are part of a GME program would lose
their Medicare funding for primary care medical education. This could
cause a clinic to discontinue its training, which is currently in high
demand and needed in rural communities. Therefore, RHCs that are
actively serving as rural primary care training sites should be
accorded an exception. For additional information regarding eligibility
as nonhospital providers for GME payments, see the Federal Register,
May 8, 1998.
B. Payment Limits for Provider-Based RHCs
We would amend Sec. 405.2462 to provide payment to all RHCs on the
basis of an all-inclusive rate per visit, subject to the per-visit
payment limit. We would also include within this section the definition
for identifying small rural hospitals with fewer than 50 beds for
purposes of the exception to the payment limit. Although these
statutory changes have already been implemented in administrative
instructions, we need to conform the regulations.
To implement this provision, we released Program Memorandum A-97-
20, ``Per-Visit Rates in Rural Health Clinics and Federally Qualified
Health Centers,'' in January 1998. That instruction directed Medicare
fiscal intermediaries to determine which RHCs are eligible for the
exception by counting the number of a provider's beds in accordance
with the regulations at Sec. 412.105(b). That regulation is part of the
provisions on calculating a teaching hospital's indirect medical
education adjustment under the prospective payment system for inpatient
hospital services and is based on ``available bed days.'' The latter
term means that the bed must be permanently maintained for lodging
inpatients and must be available for use and housed in patient rooms or
wards. Section 2405.3.G of the Medicare Provider Reimbursement Manual
contains further administrative guidance on ``available bed days.''
In defining rural and urban areas for the Medicare program, we have
consistently used the definition of ``Metropolitan Statistical Area''
(MSA) established by the Office of Management and Budget. For example,
the MSA definition is applied to identify hospitals eligible for an
exception to the prospective payment system as rural referral centers.
It is also used to determine an institution's eligibility for the
critical access hospital program and for many other purposes.
Section 4205(a) of the BBA provides an exception to the RHC payment
limit for clinics of small rural hospitals (fewer than 50 beds) for the
purpose of helping them remain financially viable. RHCs affiliated with
small rural hospitals were targeted by this provision because they are
typically located in very rural areas and represent the sole source of
health care for their communities.
As mentioned above, we issued a Program Memorandum to implement
this new payment provision, which instructed Medicare fiscal
intermediaries to use the available bed definition at Sec. 412.105(b)
for determining eligibility for the exception. Despite its
reasonableness, we recognize that some very rural providers may not
qualify for an exception using the available bed definition. To assure
continued access to primary care services in thinly populated rural
areas where the hospital and its clinic(s) are the primary source of
health care for their communities, we are proposing to adopt an
alternative definition of hospital bed size.
For hospitals that are the primary source of health care in their
community as defined at Sec. 412.92, we are proposing to look to the
hospital's average daily census rather than bed size in determining
whether RHC services are subject to the upper payment limit. We believe
average daily census may be a more appropriate measure of inpatient
capacity in certain situations (for example, rural areas that
[[Page 10456]]
experience seasonal fluctuations due to logging or commercial fishing).
To identify hospitals located in thinly populated rural areas, we
propose to use the Urban Influence Codes, a 9-category measure
developed by the U.S. Department of Agriculture. These Codes rank all
U.S. counties, ranging from 1 for large, densely populated metropolitan
counties to 9 for the most remote, sparsely populated counties. This
definition takes into account each county's largest city or town and
its proximity to counties with large urban areas. We propose to accept
an 8-level and 9-level Urban Influence Code for purposes of this
provision. An 8-level code is a county not adjacent to a metropolitan
area, but has a town with a population of 2,500 to 9,999. A 9-level is
a county not adjacent to a metropolitan area, with no place greater
than a population of 2,500. A list of the Urban Influence Codes is
available on the United States Department of Agriculture website at the
following address:http://www.econ.ag.gov/briefing/rural/data/urbinfl.txt. We believe an 8 or 9-level reflects a degree of rurality
to sufficiently target hospitals located in extremely remote areas that
may need the flexibility in the bed definition to accommodate
potentially significant fluctuations in patient census.
To assure that hospitals possess the unique characteristics of
significant fluctuations in its average daily census, we are proposing
a specific fluctuation threshold for patient census at or above 150
percent of the lowest monthly average daily census. We believe this
demonstrates a degree of fluctuation sufficient to warrant an
alternative definition of hospital bed size.
This proposed alternative definition for the aforementioned
hospitals would recognize the needs of extremely rural hospitals with
an average daily census of 40 or less to carry a larger number of
available beds in order to address seasonal fluctuations. Absent
seasonal fluctuations in patient census, it would be reasonable to
expect a hospital with an average daily census of 40 acute care
inpatients to require no more than 50 beds to meet random fluctuations
in patient census. A hospital seeking an exception on this basis would
have to submit with its cost report a summary by month of its average
acute care census. This alternative definition should afford every RHC
that was truly targeted--clinics of sole community hospitals located in
sparsely populated rural areas--an opportunity to receive an exception
to the RHC payment limit.
C. Staffing Requirements
Practitioners Available 50 Percent of the Time
Under our current regulations at Sec. 491.8(a)(6), a nurse
practitioner or physician assistant must be available to furnish
patient care services at least 60 percent of the time the RHC operates.
However, section 6213(a)(3) of OBRA 1989 amended the staffing
requirements for an RHC, described in section 1861(aa)(2)(J) of the
Act, to require that a nurse practitioner, physician assistant, or
certified nurse midwife be available to furnish patient care services
at least 50 percent of the time the RHC operates.
Therefore, we propose to revise Sec. 491.8(a) to require that a
nurse practitioner, physician assistant, or certified nurse midwife
must be available to furnish patient care at least 50 percent of the
time the RHC operates.
Temporary Staffing Waiver
As noted, section 1861(aa)(2)(J) of the Act requires an RHC to have
a nurse practitioner, physician assistant, or certified nurse midwife
available to furnish patient care services at least 50 percent of the
time the clinic operates. In addition, clause (iii) of the second
sentence of section 1861(aa)(2) of the Act requires an RHC to employ a
nurse practitioner or physician assistant. Section 1861(aa)(7) requires
us to waive one or both of these requirements for a 1-year period, if
the facility has been unable, despite reasonable efforts, to hire a
nurse practitioner, physician assistant, or certified nurse midwife in
the previous 90-day period. Before the BBA, temporary staffing waivers
were available both to RHC applicants and participating RHCs. However,
section 4205(c)(1) of the BBA amended section 1861(aa)(7)(B) of the Act
to limit waivers to RHCs that have been found qualified for Medicare
participation. Therefore, we would amend our regulations at Sec. 491.8
to provide that only currently participating RHCs (not facilities
applying for participation) are eligible for this waiver.
Procedures
We would also amend Sec. 491.8 to include procedures for when the
waiver expires. We would terminate an RHC from participation in the
Medicare program if the RHC has not recruited the required mid-level
practitioner. We would notify the RHC 15 days before the termination
date, which cannot be earlier than the day after the waiver expires.
Six-month Interim Period
Section 1861(aa)(7)(B) of the Act prohibits the Secretary from
granting a waiver if the RHC requests the waiver before 6 months after
the expiration of any previous waiver has elapsed. During this interim
6-month period, some facilities with physicians or other medical
personnel who are authorized to furnish Part B services outside of the
RHC setting and to bill Medicare on a fee-for-service basis may choose
to continue operations, while other facilities may choose to cease
operations.
Subsequent Waivers
The granting of a waiver under Sec. 491.8(d) in the past would not
preclude the granting of subsequent waiver requests if a waiver again
becomes necessary. There would be no limit to the number of staffing
waivers that a participating RHC would be able to obtain as long as the
subsequent waiver is requested no earlier than 6 months after the
expiration of the previous waiver and the clinic demonstrates it has
made a reasonable effort over the previous 90-day period to hire the
required staff.
D. Commingling
Proposed Policy
In order to achieve a clear distinction between an RHC and another
entity when the RHC is open to furnish services, and in order to remove
opportunities for duplicate billing and payments, we propose to
prohibit the use of RHC space, professional staff, equipment, and other
resources by another health care professional. This would mean that
physicians, nonphysician practitioners, and mental health professionals
(clinical psychologists and clinical social workers) cannot bill Part B
for payment for their services furnished in RHC space when the RHC is
open to furnish services to its patients.
Our proposal would prohibit these health care professionals from
using RHC space, staff, supplies, records, and other resources to
conduct a private Medicare practice. However, physicians, nonphysician
practitioners, and mental health professionals can bill Part B as long
as they clearly separate their private practices from RHC hours of
operation.
To assure that all RHC services furnished by the clinic are billed
as RHC services, we propose to revise Sec. 405.2401(b) of our
regulations, ``Scope and definitions,'' to clarify that the term
``rural health clinic'' means, in part, a facility that, in addition to
filing an
[[Page 10457]]
agreement with us to furnish RHC services under Medicare and being
approved as a Medicare RHC it is not operated simultaneously with, and
does not share professional staff, space, supplies, records, and other
resources with another entity.
Problems With Commingling
Both independent and provider-based RHCs must meet the RHC staffing
requirements in section 1861(aa)(2)(J) of the Act. The statute requires
a nonphysician practitioner to be present in the RHC to furnish
services more than 50 percent of the time the clinic is open. Providers
that routinely reassign RHC mid-level practitioners to other parts of
the provider risk failure of meeting the RHC staffing requirements.
Also, when RHC professionals and other resources are shared, they are
not available to the RHC. Therefore, the RHC is no longer meeting the
Medicare participation requirements. A complaint investigation,
undertaken by a Medicare State survey agency, could find an RHC
deficient. That deficiency could result in the termination of the RHC's
Medicare participation agreement if the RHC does not resolve the
deficiency quickly.
When RHC staff members use RHC space and resources to conduct a
private practice, Medicare could provide two payments for the
administrative cost of services furnished by a particular staff member
who had simultaneous assignments. We do not want to continue an
environment in which duplicate payments could result, because the cost,
both direct and indirect, for professional services is included in
setting the RHC payment rate. We believe that the Congress never
intended to provide opportunities for RHCs to shift between functioning
as RHCs and as other entities, such as private physician practices,
merely to achieve higher payment.
We studied several proposals to address the consequences of
commingling because we do not believe it is consistent with the statute
and often lends itself to abusive, fraudulent practices. It is an
intolerable situation that requires action on our part to eliminate its
effects. If commingling is not eliminated, incorrect and duplicate
payments could continue to be made to RHCs and physicians.
The beneficiary is disadvantaged when commingling occurs. When the
physician's billing decisions for services are based on which Medicare
payment for the services is higher (the RHC's all-inclusive rate, or
the amounts payable under the non-RHC Part B payment provisions), the
result is an inflated Medicare payment and an inflated coinsurance
amount charged to the beneficiary.
Commonly, RHCs maintain a unit record for each patient, but patient
visits to the RHC and to the physician practice are not well
differentiated. By combining patient records, these RHCs call into
question the correctness of their payments, the proper maintenance of
records as required by Sec. 491.10(a), and the appropriateness of
payment to the physician.
Exception to Commingling
Although we believe strong action is needed, we want to make sure
our proposed policy does not create hardship for physicians and
patients in rural underserved communities, such as frontier areas with
limited medical resources. Therefore, with sufficient documentation
allocating costs associated with the sharing of staff, we propose
offering critical access hospitals the option to share common staff
between the RHC and the emergency room. We believe this exception is
necessary because recruitment of physicians into rural communities is
very difficult. An isolated community often does not have the ability
to hire and maintain a sufficient number of practitioners to staff both
the RHC and emergency room simultaneously within a critical access
hospital. We are also inviting the public to offer additional
suggestions regarding how to address the negative effects of
commingling.
Cost Reports
To assure that physicians clearly separate their private practices
from the RHC, we have revised the Medicare cost report for independent
and provider-based clinics to collect information that may be used by
the fiscal intermediary to determine if commingling exists at an
approved RHC. This will help assure that RHCs do not claim the cost of
services that Medicare is paying for outside the RHC payment system.
This cost report information, which includes describing any other
entity that occupies RHC space and hours of operation, would alert the
fiscal intermediary to the existence of possible commingling and allow
the fiscal intermediary to determine if it should examine the costs
reported in more detail.
E. Quality Assessment and Performance Improvement Program
During the last decade, the health care industry has moved beyond
the problem-focused approach of quality assurance in favor of focusing
on systemic quality improvement. We have followed suit. Our revised
approach to our quality assurance responsibilities is linked closely
both to the Administration's commitment to reinventing government. Our
revised quality initiatives are now focused on stimulating improved
health outcome and patient satisfaction. To achieve this objective, we
are now developing revised requirements for several health care
providers; that is, hospitals, hospices, end-stage renal disease
facilities, and home health agencies. These requirements are directed
at improving outcomes of care and satisfaction for patients while
eliminating unnecessary procedural requirements. This was, largely, the
impetus for the revised legislation concerning requiring a quality
improvement program for RHCs discussed above.
A quality assessment and performance improvement (QAPI) program
should be based on a continuous, proactive approach to both managing
the RHC and improving outcomes of care and satisfaction for patients.
Instead of continuing to prescribe the structure and processes by
which an RHC evaluates its services, we have identified the outcome
expected of an RHC that assesses its performance and improves the
services that it provides to beneficiaries. For this condition of
certification, we are proposing to eliminate structural or process-
oriented requirements that we believe are no longer necessary (such as
prescriptive details concerning policies and procedures, reviewing
medical records, etc.). At this time, we are not making changes to all
of part 491 to make it outcome oriented. Maybe, in the future, we will
change all of part 491 to focus on outcomes.
A recent study of the Institute of Medicine (IOM) of the National
Academies discussed medical errors as one of the nation's leading
causes of death and injury. The study estimated that more people die
from medical errors each year than from highway accidents, breast
cancer, or autoimmune deficiency syndrome. We have been concerned about
medical errors for some time and are exploring how to address this
issue through our rulemaking process.
We want to make it clear that the requirements of QAPI set forth in
this proposed rule for RHCs will address the issues of measuring and
prioritizing the medical errors of underuse, overuse, and misuse. These
issues are clearly concerns of the public, healthcare providers, and
others, as highlighted by the IOM study. RHCs will be required to
[[Page 10458]]
develop and implement programs that will foster continuous and
proactive approaches to discovering and prioritizing opportunities to
improve patient outcomes. Medical errors would clearly be a priority
area for improvement actions.
We are proposing to replace the current requirements in Sec. 491.11
with the proposed QAPI condition that contains three standards: the
first addresses the components of a performance improvement program;
the second addresses monitoring performance activities; and the third
addresses program responsibilities.
Clinical Effectiveness
The first proposed standard charges each RHC with the
responsibility to carry out a performance improvement program of its
own design to improve the quality of care furnished to its patients.
Each clinic would have to develop, implement, maintain, and evaluate an
effective, data-driven, QAPI program based on its individual needs and
resources. This requirement would stimulate an RHC to monitor and
improve its own performance continuously and to be responsive to the
needs and desires of its patients to ensure their satisfaction. The
program would be required to reflect the complexity of the RHC's
organization and services. We believe that the gathering and reviewing
of data are important steps in the process to improve the quality of
services provided to beneficiaries of the Medicare and Medicaid
programs. As a result of the evaluation of improvement measures, RHCs
would be able to support the sharing of best practices among their
peers.
The RHC's QAPI program should achieve, through ongoing measurement
and intervention, demonstrable and sustained improvement in significant
aspects of clinical care and nonclinical services that can be expected
to affect the population it serves. With an effective QAPI program, the
RHC would, on a continuous basis, be able to identify and reinforce
activities that it is doing well and identify and respond to
opportunities for improvement.
We would not prescribe the structures and methods for implementing
this requirement and would focus the condition for certification on the
expected results of the program; that is, improved quality of care.
This would provide flexibility to the RHC, as it would be free to
develop a creative program that meets the RHC's needs and reflects the
scope of its services.
Key Elements. The RHC should develop its program that meets the
RHC's needs (and reflects the scope of its services) with four key
elements in mind:
Identify and prioritize opportunities to improve health
status and health care.
Conduct intervention(s) developed to target specific
populations.
Include documentation of results.
Identify additional opportunities to improve health status
and health care.
We would require that an RHC set priorities for performance
improvement based on the prevalence and severity of identified
problems. Of course, we expect that an RHC would immediately correct
problems that are identified through its quality assessment and
performance improvement program that actually or potentially affect the
health and safety of patients. For example, if a clinic's QAPI process
identifies problems with accuracy of medication administration, it
would not be enough for the clinic to consider this area a candidate
for an improvement program that may or may not be chosen from a
priority list of potential projects. Rather, since accuracy of
medication administration is critical to the health and safety of
patients, the clinic would have to intervene with a correction and
improvement program immediately. Overall, a clinic would be expected to
give priority to improvement activities that most affect clinical
outcomes.
Critical Areas. Specifically, we would require that an RHC
objectively evaluate the following areas that we believe are critical
to an RHC's performance:
Domain 1. Clinical Effectiveness
Appropriateness of Care. This area evaluates the
appropriateness of care provided to the patients. That is, it evaluates
whether needed tests, procedures, treatment, and services are provided
to a patient in a timely and appropriate manner.
Prevention. There are no requirements for the provision of
preventive health services for an RHC. However, if these services are
provided, there should be continuous evaluation of the areas as part of
the clinic's QAPI program. Preventive health services may include
medical social services, nutritional assessment and referral,
preventive health education, children's eye and ear examinations,
perinatal services, well-child services, preventive health screenings,
immunizations, and voluntary family planning services.
Domain 2. Access to Care
Access is a multifaceted concept that encompasses transportation
and geographic location, outreach, cultural relevance, financial
barriers, patient acceptance, and convenient practice hours. By
identifying quality concerns and the development of corrective actions
in this area, it is anticipated that access to covered services would
improve. Also, patient satisfaction should increase.
Availability and Accessibility. The RHC would have to
assure that all services are available (that is, it has employed
appropriately qualified practitioners and providers) and that these
practitioners and providers have sufficient capacity to make services
available to the patient population. The RHC would also have to ensure
accessibility: that is, patients could obtain available services in a
timely fashion, with consideration of travel time, waiting time, and
potential access barriers for special populations, such as the disabled
or non-English speaking members.
Cultural Competency. This includes the attainment of
knowledge, skills, and attitudes that enable administrators and
practitioners within systems of care to provide and support effective
health care delivery for diverse populations. Focuses for Domain 2
could include: decreasing the waiting times when appointments are
scheduled and after arriving at the clinic; improving the access rates
for patients with chronic disorders or patients with special needs;
examining the effectiveness of an outreach program for a specific
population; identifying current and potential barriers to care;
evaluating staffing needs to ensure service availability.
Emergency Intervention. An RHC is required to provide
medical emergency procedures as a first response to common life-
threatening injuries and acute illnesses. The definition of first
response is service that is commonly provided in a physician's office.
There are no specific requirements for an RHC to directly provide on
call coverage. However, the RHC would have to arrange for access to
care; that is, referral to a hospital outpatient department. Therefore,
focuses could include follow-up activities to examine the effectiveness
of the initial assessment and treatment.
Domain 3. Patient Satisfaction
Soliciting feedback from patients on the quality of care they
receive (including complaints and grievances) is not only reflective of
good patient care, but it is also a sound business practice.
Quality of care can typically be categorized in two ways: perceived
and technical. We have discussed the technical aspects of measuring
quality in the section ``Clinical Effectiveness.''
[[Page 10459]]
Perceived quality deals with the assessment of quality as experienced
by the patient. Patients often base their satisfaction on how well they
were treated by the staff--the amount of time spent waiting to be seen,
and the time and attention given to their concerns.
The clinic could utilize a standardized survey instrument for
purposes of determining whether the patients served by the clinic are
satisfied with the care received, or they may design their own survey
instrument. Elements in the survey should capture--
Access, communication and interaction with health care
professionals;
Continuity and coordination of care;
Preventive care (where applicable);
Paperwork burden on the patient;
Complaints and grievances;
Utilization of health services;
Health status; and
Respondent characteristics.
Information collected could be used to improve quality of care or
adjust practice patterns to better meet the needs of the patient.
Examples of a Quality Improvement Project
We want to assure RHCs, especially clinics that are operating with
a limited staff and resources, that our expectations for the use of
performance measures are commensurate with the size and resources
available to the clinic. Effective improvement programs can be and are
often premised on simple, straightforward designs, using measures that
are direct and uncomplicated. For example, a patient satisfaction
survey could be used to evaluate whether the clinic should alter
practice hours to accommodate patients that need evening appointments.
We are not proposing specific language for a minimum level in the
regulation text at this time because we recognize that there are many
ways in which such a level can be set. We are inviting comments on the
best approaches to achieve this minimum level of effort for clinics
that currently do not have a performance improvement program and have
limited resources to develop a QAPI program.
Among the possible alternatives that we are considering are the
following:
Require RHCs to engage in an improvement project in each
domain annually.
Require a minimum number of improvement projects (for
example, two) in any combination of the domains annually. Require a
minimum number of projects annually based on patient population (for
example, three projects for every 1,000 patients).
Rather than requiring a minimum number of projects,
require RHCs to demonstrate to the survey agency what projects they are
doing and what progress is being achieved.
We are certain there are other ways to approach the ``minimum-
effort'' discussion. The purpose of these examples is to elicit comment
and suggestions in this regard, and we welcome alternative approaches.
We note that although our intention is to specify in the final rule a
minimum level of effort, it is also possible that, after reviewing all
the comments, we may conclude that it is neither feasible nor desirable
to do so.
Monitoring Performance Activities
The second standard proposed at Sec. 491.11(b) states that, for
each of the areas listed under standard (a), the clinic must measure,
analyze, and track aspects of performance that the clinic adopts or
develops that reflect processes of care and clinic operations. These
measures must be shown to be predictive of desired outcomes or be the
outcomes themselves.
When we use the word ``measure,'' we mean that the RHC would have
to use objective means of tracking performance that enables a clinic
(and a surveyor) to identify the differences in performance between two
points in time. For example, we would not consider a clinic's
subjective statement that it is ``doing better'' in a given performance
area as a result of an improvement process to be an acceptable measure.
We would require identifiable units of measure that a reasonably
knowledgable person would be able to distinguish as evidence of change.
Not all objective measures would have to be shown to be valid and
reliable (that is, subjected to scientific rigor) in order to be usable
in improvement projects, but they would have to at least identify a
start point and an end point stated in objective terms, most often,
numbers that actually relate directly to the objectives and expected or
desired outcomes of the improvement project.
Program Responsibilities
Under the third proposed standard, Sec. 491.11(c), we are proposing
that the RHC's professional staff, administration officials, and
governing body (where applicable) ensure that there is an effective
quality assessment and performance improvement program as well as the
current requirement for assessing utilization. The RHC would have to
prioritize areas of improvement, considering prevalence and severity of
identified problems and giving priority of improvement to those
activities that affect clinical outcomes.
We anticipate that both large and small RHCs will use a variety of
performance measures in their QAPI program. These measures may be
designed by the clinic itself or by other sources outside the RHC.
Regardless, HCFA intends, through its survey process, to assess the
clinic's success in collecting data on its operation and measuring
quality. Each clinic's professional staff should use its judgement,
which is supported by nationally approved standards, practices and
reviews of current professional literature, to evaluate the quality of
care performed in the clinic. The survey process would focus on the
clinic's ability to demonstrate that it has developed a viable quality
assessment and performance improvement program. Also, the clinic should
be able to prove with objective data that sustained improvements have
taken place in (1) actual care outcomes, patient satisfaction levels,
and access to care; and/or (2) processes of care and clinic operations
that are predictive of improved outcomes of care and satisfaction for
patients. HCFA does not intend and would not be in a position to judge
the measures themselves; instead, we would assess their utility for the
clinic in its own efforts to improve its performance. As part of
oversight, we would expect RHCs to make information on their QAPI
program available for surveyors during initial certification, routine
recertification, and complaint surveys to demonstrate how they meet the
requirement.
III. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, we are required to
provide 60-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (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 Paperwork Reduction Act
of 1995 requires that we solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the
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affected public, including automated collection techniques.
Therefore, we are soliciting public comment on each of these issues
for the information collection requirements discussed below.
Section 491.3 Rural Health Clinic (RHC) Procedures
Section 491.3(c)(2) states that an existing RHC located in an area
no longer considered a shortage area may apply for an exception from
disqualification by submitting a written request to the HCFA regional
offices within 90 days from the date HCFA notifies it that it is no
longer located in a shortage area. We believe that this information
collection requirement is exempt in accordance with 5 CFR 1320.4(a)(2)
since this activity is pursuant to the conduct of an investigation or
audit against specific individuals or entities.
Section 491.8 Staffing and Staff Responsibilities
Section 491.8(d)(1) states that HCFA may grant a temporary waiver
if the RHC requests a waiver and demonstrates that it has been unable,
despite reasonable efforts in the previous 90-day period, to hire a
nurse midwife, nurse practitioner, or physician assistant to furnish
services at least 50 percent of the time the RHC operates.
The burden associated with this requirement is the time and effort
for the RHC to request a waiver and demonstrate that it has been unable
to hire a nurse midwife, nurse practitioner, or physician assistant to
furnish services at least 50 percent of the time the RHC operates. It
is estimated that this requirement will take each RHC 3 hours. There
are approximately 45 RHCs that will be affected by this requirement for
a total of 135 burden hours.
Section 491.11 Quality Assessment and Performance Improvement
states that the RHC must develop, implement, evaluate, and maintain an
effective, ongoing, data-driven quality assessment and performance
improvement program. The RHC's QAPI program must include, but not be
limited to, the use of objective measures to evaluate clinical
effectiveness, access to care, patient satisfaction, and utilization of
clinical services, including at least the number of patients served and
the volume of services.
Most of the burden of this section is covered by the paperwork
requirements of Sec. 491.9(b)(3), patient care policies, which requires
the RHCs to have in place a description of services the clinic
furnishes, guidelines for management of health problems, and procedures
for periodic review and evaluation of clinic services. This burden is
approved under 0938-0334 and expires in April, 2000.
To maintain the data required by Sec. 491.11, we estimate it will
take each clinic one hour per year to meet this requirement. Since
there are an estimated 3,528 facilities, the total burden associated
with this requirement is 3,528 annual hours.
We have submitted a copy of this proposed rule to OMB for its
review of the information collection requirements described above.
These requirements are not effective until they have been approved by
OMB.
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 NO-14-26, 7500 Security Boulevard, Baltimore, MD 21244-1850,
ATTN.: Louis Blank, HCFA-1910-P; and
Office of Information and Regulatory Affairs, Office of Management and
Budget, Room 10235, New Executive Office Building, Washington, DC
20503, ATTN.: Allison EDT, HCFA Desk Officer
IV. 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 major comments in the preamble to that
document.
V. Regulatory Impact Statement
Overall Impact
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). 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. For purposes of
the RFA, all RHCs are considered to be small entities. 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 603 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 proposed rule that may result in an expenditure in any one
year by State, local, or tribal government, in the aggregate, or by the
private sector of $100 million. The proposed rule would not have an
effect on the governments mentioned, and private sector costs would be
less than the $100 million threshold.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct compliance costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. The proposed rule would not have an effect on the
governments mentioned.
Although we view the anticipated results of these proposed
regulations as beneficial to the Medicaid and Medicare programs as well
as to Medicaid recipients and Medicare beneficiaries and State
governments, we recognize that some of the provisions could be
controversial and may be responded to unfavorably by some affected
entities. We also recognize that not all of the potential effects of
these provisions can definitely be anticipated, especially in view of
their interaction with other Federal, State, and local activities
regarding outpatient services. In particular, considering the effects
of our simultaneous efforts to improve the delivery of outpatient
services, it is impossible to quantify meaningfully a projection of the
future effect of all of these provisions on RHC's operating costs or on
the frequency of substantial
[[Page 10461]]
noncompliance and termination procedures.
We believe the foregoing analysis concludes that this regulation
would not have a significant financial impact on a substantial number
of small entities, such as RHCs. This analysis, in combination with the
rest of the preamble, is consistent with the standards for analysis set
forth by the RFA.
Anticipated Effects
Effects on Rural Health Clinics
The total number of participating RHCs under Medicare and Medicaid
as of March 1, 1998, was 3,528. Participating RHCs that are no longer
located in rural, underserved areas could lose their RHC status and
their cost-based reimbursement, which could cause them to reduce
services or discontinue serving our beneficiaries. To minimize the
impact of this provision on rural health care, the Congress has
authorized us to grant, if needed, an exception to clinics essential to
the delivery of primary care in these affected areas. Our proposed
criteria in Sec. 491.3 would identify the areas and clinics where RHC
status and its payment methodology would still be needed despite the
fact the service area is no longer considered medically underserved.
Implementing the statutory requirement to replace the current
payment method used by provider-based RHCs to the payment method used
by independent RHCs will establish payment equity and consistency
within the RHC program. Before the BBA, payment to provider-based RHCs
was made without considering the number of patient visits provided by
the RHC without a limit on the payment per visit. These criteria are
applicable to independent RHCs that furnish the same scope of services.
Our proposal to codify the statutory requirement to pay all RHCs under
an all-inclusive rate per visit also would avoid allocation of
excessive administration costs to RHCs. We believe that about a
thousand RHCs would be affected by this proposal.
We believe the fiscal impact of limiting payment to provider-based
RHCs to the independent RHC rate per visit will result in program
savings. Provider-based RHCs that have costs above the all-inclusive
cost-per-visit limit required by the law could experience some decrease
in their current reasonable cost basis payments. To reduce detrimental
impacts of this decrease, the Congress authorized an exception to the
annual payment limit to those clinics affiliated with small rural
hospitals; that is, a hospital that is located outside of a
Metropolitan Statistical Area and has fewer than 50 beds.
This QAPI requirement may increase burden in the short term because
resources would have to be devoted to the development of a quality
assessment and performance improvement program that covers the
complexity and scope of the particular clinic. However, while the
proposed requirements could result in some immediate costs to an
individual clinic, we believe that the QAPI program will result in
real, but difficult to estimate, long-term economic benefits to the
clinic (such as cost-effective performance practices or higher patient
satisfaction that could lead to increased business for the clinic).
Moreover, we are proposing that the QAPI and utilization review
requirements replace the current annual evaluation requirement.
Resources that the clinics are currently using for the annual
evaluation could be devoted to the QAPI program. Therefore, we believe
that there would be no long-term increased burden to the clinics.
Currently, a number of RHCS, primarily provider-based, have some type
of quality improvement program in place. To the extent that clinics are
familiar with collecting data on their operations and measuring
quality, the new requirement would not be perceived as a burden.
OBRA 1989 reduced the nonphysician staffing requirement for RHC
qualification from 60 percent to 50 percent. This reduction should have
a positive effect on RHCs by providing them more flexibility in
satisfying their overall staffing needs.
Effects on Other Providers
We are aware of situations in which an RHC and a physician's
private practice occupy the same space and Medicare is billed for the
service, either as an RHC or physician service, depending upon which
payment method produces the greater payment. Our proposed revision
would require an RHC to be a distinct entity that is not used
simultaneously as a private physician office or the private office of
any other health care professional. As a result, a private physician or
other practitioner who has used this approach to take advantage of the
Medicare program may experience some change in the operation of their
practices from an administrative standpoint.
Effects on the Medicare and Medicaid Programs
As a result of this proposed rule, most provider-based RHCs would
be subject to payment limits and some RHCs would lose their RHC status
and cost-based payment rates. Although these proposed changes would
likely result in program savings, we believe the aggregate amount would
be negligible for both programs. We cannot accurately estimate the
payment differential between the new payment system for provider-based
RHCs and the previous payments because the old system made payments
without considering the number of patient visits. Without these data,
we cannot precisely determine the fiscal impact.
However, in light of the fact that total expenditures for this
program represent a small fraction of the Medicare and Medicaid's total
budget and that less than half of all RHCs would experience changes to
their payment rates, we believe any aggregate savings would be
insignificant. We also believe an insignificant amount of Medicare and
Medicaid program savings would result from the proposed provision that
would terminate RHC status for certain providers. Less than 5 percent
of all participating RHCS could lose their status, and these affected
clinics would continue to participate under Medicare and Medicaid and
receive payment for their services on a fee-for-service basis.
Alternatives Considered
Section 4205 of the BBA imposes new requirements that an RHC
program must meet. We considered some of the following alternatives to
implement these provisions:
``Essential'' RHCs. Since the statute mandates an exception process
for essential clinics, we considered using a national utilization test
to recognize clinics that are accepting and treating a
disproportionately greater number of Medicare, Medicaid, and uninsured
patients, compared to other participating RHCs, for the purpose of
addressing the situation of RHC clusters. For example, using an
aggregate threshold based on the average Medicare, Medicaid, and
uninsured utilization rates of participating RHCs, applicants would
have to demonstrate that their utilization rates exceed the threshold.
Although the test would be administratively feasible, we concluded,
based on our analysis of available Medicare and Medicaid RHC data, that
it would not accurately determine ``essential'' clinics at the
community level because of the wide variability in
[[Page 10462]]
the percentage of services furnished to Medicare and Medicaid patients
by RHCs. Despite our rejection of a national utilization test, we are
open to suggestions on developing a minimum national percentage, which
could be integrated with our proposed major community provider test.
QAPI Program. Because the statute mandates that an RHC have a QAPI
program, and appropriate procedures for review of utilization of clinic
services, no alternatives for the requirement were considered. However,
in the preamble section we have proposed alternative ways of satisfying
the ``minimum level requirement'' for the QAPI program and have asked
for comments. Among the alternatives that we are considering are the
following:
Require RHCs to engage in an improvement project in each
domain annually.
Require a minimum number of improvement projects in any
combination of the domains annually.
Require a minimum number of projects annually based on
patient population.
Rather than requiring a minimum number of projects,
require RHCs to demonstrate to the survey agency what projects they are
doing and what progress is being achieved.
Conclusion
We would not expect a significant change in the operations of RHCs
generally, nor do we believe a substantial number of small entities in
the community, including RHCs and a substantial number of small rural
hospitals, would be adversely affected by these proposed changes. The
commingling provision of this regulation adds little savings. One
reason for this conclusion is that the outpatient visit rate for HCPC
99214 was about $59.00 and the RHC visit was also about $59.00.
Therefore, if an adjustment made for lower physician overhead than that
of the RHC, the savings would probably be marginal.
Therefore, we are not preparing analyses for either the regulatory
impact analysis or section 1102(b) of the Act since we believe that
this proposed rule would not result in a significant economic impact on
a substantial number of small entities and would not have a significant
impact on the operations of a substantial number of small rural
hospitals. We solicit public comments on the extent to which any of the
entities would be significantly economically affected by these
provisions.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
List of Subjects
42 CFR Part 405
Administrative practice and procedure, Health facilities, Health
professions, Kidney diseases, Medicare, Reporting and recordkeeping
requirements, Rural areas, X-rays.
42 CFR Part 491
Grant programs-health, Health facilities, Medicaid, Medicare,
Reporting and recordkeeping requirements, Rural areas.
For the reasons set forth in the preamble, 42 CFR chapter IV would
be amended as set forth below:
PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED
Subpart X--Rural Health Clinic and Federally Qualified Health
Center Services
1. The authority citation for part 405, subpart X, continues to
read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
2. In Sec. 405.2401(b), the definition of ``rural health clinic''
is revised to read as follows:
Sec. 405.2401 Scope and definitions.
* * * * *
(b) Definitions.
* * * * *
Rural health clinic (RHC) means an entity that meets the following
criteria:
(1) It does not share space, professional staff, supplies, records,
and other resources during RHC hours of operation with a private
physician's office or the office of any other health care professional.
RHCs physically located on the same campus of a critical access
hospital have the option of sharing common staff between the RHC and
the emergency room.
(2) It has filed an agreement with HCFA that meets the basic
requirements described in Sec. 405.2402 to furnish RHC services under
Medicare.
(3) HCFA has determined that the entity meets the requirements of
section 1861(aa)(2) of the Act and part 491 of this chapter concerning
RHC services and conditions for approval.
* * * * *
3. Section 405.2410 is revised to read as follows:
Sec. 405.2410 Application of Part B deductible and coinsurance.
(a) Application of deductible. (1) Medicare payment for RHC
services begins only after the beneficiary has incurred the deductible.
Medicare applies the Part B deductible as follows:
(i) If the deductible has been fully met by the beneficiary before
the RHC visit, Medicare pays 80 percent of the all-inclusive rate.
(ii) If the deductible has not been fully met by the beneficiary
before the visit and the amount of the RHC's reasonable customary
charge for the service that is applied to the deductible is--
(A) Less than the all-inclusive rate, the amount applied to the
deductible is subtracted from the all-inclusive rate and 80 percent of
the remainder, if any, is paid to the RHC; or
(B) Equal to or exceeds the all-inclusive rate, no payment is made
to the RHC.
(2) Medicare payment for FQHC services is not subject to the usual
Part B deductible.
(b) Application of coinsurance. (1) The beneficiary is responsible
for the coinsurance amount that cannot exceed 20 percent of the
clinic's reasonable customary charge for the covered service.
(2) The beneficiary's deductible and coinsurance liability, with
respect to any one service furnished by the RHC may not exceed a
reasonable amount customarily charged by the RHC for that particular
service.
(3) For any one service furnished by an FQHC, the coinsurance
liability may not exceed 20 percent of reasonable amount customarily
charged by the FQHC for that particular service.
4. Section 405.2462 is revised to read as follows:
Sec. 405.2462 Payment for rural health clinic services and Federally
qualified health clinic services.
(a) General rules. (1) RHCs and FQHCs are paid on the basis of 80
percent of an all-inclusive rate per visit determined by the fiscal
intermediary for each beneficiary visit for covered services, subject
to an annual payment limit.
(2) The fiscal intermediary determines the all-inclusive rate in
accordance with this subpart and instructions issued by HCFA.
(3) If an RHC is an integral and subordinate part of a rural
hospital, it can receive an exception to the per-visit payment limit if
its rural hospital is not located in a metropolitan statistical area as
defined in Sec. 412.62(f)(1)(ii)(A) of this chapter and has fewer than
50 beds as determined by using one of the following methods:
[[Page 10463]]
(i) The definition at Sec. 412.105(b) of this chapter.
(ii) The hospital's average daily patient census count of those
beds described in Sec. 412.105(b) of this chapter and the hospital
meets all of the following conditions:
(A) It is a sole community hospital as determined in accordance
with Sec. 412.92 of this chapter.
(B) It is located in an 8-level or 9-level nonmetropolitan county
using Urban Influence Codes as defined by the U.S. Department of
Agriculture.
(C) It has an average daily patient census that does not exceed 40.
(D) It has significant fluctuations in its average daily census to
the extent that the average daily census for 1 or more months is at
least 150 percent of the lowest monthly average daily census.
(b) Payment procedures. To receive payment, an RHC or FQHC must
follow the payment procedures specified in Sec. 410.165 of this
chapter.
(c) Mental health limitation. Payment for the outpatient treatment
of mental, psychoneurotic, or personality disorders is subject to the
limitations on payment in Sec. 410.155(c) of this chapter part 491.
PART 491--CERTIFICATION OF CERTAIN HEALTH FACILITIES
1. The authority citation for part 491 continues to read as
follows:
Authority: Sec. 1102 of the Social Security Act (42 U.S.C.
1302); and sec. 353 of the Public Health Service Act (42 U.S.C.
263a).
2. Section 491.2 is revised to read as follows:
Sec. 491.2 Definition of shortage area for RHC purposes.
Shortage area means a geographic area that meets one of the
following criteria. It has been:
(a) Designated by the Secretary as an area with shortage of
personal health services under section 330(b)(3) of the Public Health
Service Act;
(b) Designated by the Secretary as a health professional shortage
area under section 332(a)(1)(A) of that Act because of its shortage of
primary medical care professionals;
(c) Determined by the Secretary to contain a population group that
has a health professional shortage under 332(a)(1)(B) of that Act; or
(d) Designated by the chief executive officer of the State and
certified by the Secretary as an area with a shortage of personal
health services.
3. Section 491.3 is revised to read as follows:
Sec. 491.3 RHC procedures.
(a) General. (1) HCFA processes Medicare participation matters for
RHCs in accordance with Secs. 405.2402 through 405.2404 of this chapter
and with the applicable procedures in part 486 of this chapter.
(2) If HCFA approves or disapproves the participation request of a
prospective RHC, it notifies the State Medicaid agency for that RHC.
(3) HCFA deems an RHC that is approved for Medicare participation
to meet the standards for certification under Medicaid.
(b) Current designation. Applicants requesting entrance into the
Medicare program as an RHC must be located in a current shortage area,
whose designation has been made or updated within the current year or
within the previous 3 years.
(c) Exception process. (1) An RHC's location fails to satisfy the
definition of a shortage area if it is no longer designated by the
Secretary or by the chief executive officer of the State as medically
underserved.
(2) An existing RHC may apply for an exception from
disqualification by submitting a written request to the HCFA regional
office within 90 days from the date HCFA notifies it that it is no
longer located in a shortage area. The request must contain all
information necessary to establish whether an exception is warranted.
(3) Based on its review of an RHC request, and other relevant
information, if the HCFA regional office determines that the RHC is
essential to the delivery of primary care services that otherwise would
not be available in the geographic area served by the RHC, consistent
with Sec. 491.5(b), the HCFA regional office may grant a 3-year
exception to the RHC.
(4) HCFA terminates an ineligible clinic from participation in the
Medicare program as an RHC 90 days after HCFA notifies the clinic of
its ineligibility under this section.
4. In Sec. 491.5, paragraphs (d) and (e) are removed, paragraph (f)
is redesignated as paragraph (d), and paragraph (b) is revised to read
as follows:
Sec. 491.5 Location of clinic.
* * * * *
(b) Exceptions. If HCFA determines that the RHC has established
that it is essential to the delivery of primary care that otherwise
would not be available in the geographic area served by the RHC, HCFA
does not disqualify the RHC approved for Medicare participation if the
area in which the RHC is located no longer meets the definition of a
shortage area. HCFA makes this determination when the RHC meets one of
the following conditions:
(1) Sole community provider. The RHC is the only participating
primary care provider within 30 minutes travel time. For purposes of
this exception, a participating primary care provider means an RHC, an
FQHC, or a physician practicing in either general practice, family
practice, or general internal medicine that is actively accepting and
treating Medicare beneficiaries and Medicaid recipients. RHCs applying
for an exception under this test must demonstrate that they accept
Medicare (where applicable), Medicaid, and uninsured patients that
present themselves for treatment. HCFA uses the following criteria in
determining distances corresponding to 30 minutes travel time:
(i) Under normal conditions with primary roads available--20 miles.
(ii) In areas with only secondary roads available--15 miles.
(iii) In flat terrain or in areas connected by interstate
highways--30 miles.
(2) Traditional community provider. RHC is the only participating
RHC within 30 minutes travel time and is actively accepting and
treating Medicare, Medicaid, and uninsured patients. HCFA does not
grant an exception under this test if the RHC's service area (30
minutes travel time) has two or more participating primary care
providers that have been actively treating Medicare beneficiaries and
Medicaid recipients for a minimum of 5 years. For purposes of this
exception, a primary care provider means an FQHC or a physician
practicing in either general practice, family practice, or general
internal medicine.
(3) Major community provider. The RHC is treating a
disproportionately greater share of Medicare, Medicaid, and uninsured
patients compared to other participating RHCs that are within 30
minutes travel time.
(4) Speciality clinic. The RHC is the sole clinic that provides
pediatric or obstetrical/gynecological services and actively serves
Medicare (where applicable), Medicaid, and uninsured patients.
(5) Graduate medical education test. The RHC is actively part of an
approved medical residency training program as defined in Secs. 413.86
and 405.2468(f) of this chapter.
* * * * *
4. In Sec. 491.8, paragraph (a)(6) is revised and a new paragraph
(d) is added to read as follows:
Sec. 491.8 Staffing and staff responsibilities.
(a) * * *
(6) A physician, nurse practitioner, physician assistant, nurse-
midwife,
[[Page 10464]]
clinical social worker, or clinical psychologist is available to
furnish patient care services at all times the clinic or center
operates. In addition, for RHCs, a nurse practitioner, physician
assistant, or certified nurse midwife is available to furnish patient
care services at least 50 percent of the time the RHC operates.
* * * * *
(d) Temporary staffing waiver. (1) HCFA may grant a temporary
waiver of the RHC staffing requirements in paragraphs (a)(1) and (a)(6)
of this section for a 1-year period to a qualified RHC, if the RHC
requests a waiver and demonstrates that it has been unable, despite
reasonable efforts in the previous 90-day period, to hire a nurse
midwife, nurse practitioner, or physician assistant to furnish services
at least 50 percent of the time the RHC operates.
(2) If the RHC is not in compliance with the provisions waived
under paragraph (a)(1) and paragraph (a)(6) of this section at the
expiration of the waiver, HCFA terminates the RHC from participation in
the Medicare program.
(3) The RHC may submit its request for an additional waiver of
staffing requirements under this paragraph no earlier than 6 months
after the expiration of the previous waiver.
5. Section 491.11 is revised to read as follows:
Sec. 491.11 Quality assessment and performance improvement.
The RHC must develop, implement, evaluate, and maintain an
effective, ongoing, data-driven quality assessment and performance
improvement (QAPI) program. The program must be appropriate for the
level of complexity of the RHC's organization and services. The program
should achieve, through ongoing measurement and intervention,
demonstrable and sustained improvement in significant aspects of
clinical care and nonclinical services.
(a) Standard: Components of a QAPI program. (1) The RHC's QAPI
program must include, but not be limited to, the use of objective
measures to evaluate the following:
(i) Clinical effectiveness (for example, appropriateness of care,
and prevention).
(ii) Access to care (for example, availability and accessibility of
services, cultural competency, and emergency intervention).
(iii) Patient satisfaction.
(iv) Utilization of clinic services, including at least the number
of patients served and the volume of services.
(2) Projects that focus on clinical areas should include, at a
minimum, high-volume and high-risk services, the care of acute and
chronic conditions, and coordination of care.
(3) Projects that focus on nonclinical services should include, at
a minimum, criteria to measure convenience and timeliness of available
services and grievances and complaints.
(b) Monitoring performance activities. For each of the areas listed
in paragraph (a)(1) of this section, the RHC must adopt or develop
performance criteria that reflect processes of care and RHC operations.
The RHC must use those criteria to analyze and track its performance.
These performance criteria must be shown to be predictive of desired
patient outcomes or be the outcomes themselves.
(c) Program responsibilities. The RHC's professional staff,
administrative officials, and governing body (if applicable) are
responsible for ensuring that quality assessment and performance
improvement efforts effectively address identified priorities. They are
responsible for identifying or approving those priorities and for the
development, implementation, and evaluation of improvement actions.
(Catalog of Federal Domestic Assistance Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: March 1, 1999.
Nancy-Ann Min DeParle,
Administrator, Health Care Financing Administration.
Dated: September 2, 1999.
Donna S. Shalala,
Secretary.
[FR Doc. 00-4389 Filed 2-25-00; 8:45 am]
BILLING CODE 4120-01-P