[Federal Register Volume 71, Number 184 (Friday, September 22, 2006)]
[Rules and Regulations]
[Pages 55341-55347]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-7886]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 405 and 491
[CMS-1910-IFC]
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; Suspension of
Effectiveness
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Interim final rule with comment period; partial suspension of
effectiveness.
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SUMMARY: This interim final rule with comment period revises the rural
health clinic (RHC) regulations to revert to those provisions set forth
in regulations before publication of the December 24, 2003 RHC final
rule. That final rule implemented certain provisions of the Balanced
Budget Act (BBA) of 1997 to establish a process and criteria for
disqualifying from the RHC program clinics that no longer meet basic
location requirements (rural and medically underserved), and to require
RHCs to establish quality assessment and performance improvement
programs. That rule also prohibited ``commingling'' (the use of the
space, professional staff, equipment, and other resources) of an RHC
with another entity. [In addition, it addressed comments on the
February 28, 2000 proposed rule. Since the publication of the RHC final
rule exceeded the 3-year timeline for finalizing proposed rules set by
the Medicare Prescription Drug, Improvement, and Modernization Act of
2003, we are suspending the effectiveness of the current provisions by
removing the RHC provisions set forth in the December 2003 final rule
and reverting to those RHC provisions previously in effect.] We intend
to reissue new proposed and final RHC rules to reinstate the current
provisions. However, these revisions do not impact the effectiveness of
the self-implementing provisions of the BBA or any provisions we had
previously implemented or enforced through program memoranda.
DATES: Effective date: These regulations are effective on September 22,
2006.
Comment date: To be assured consideration, comments must be
received at one of the addresses provided below, no later than 5 p.m.
on November 21, 2006.
ADDRESSES: In commenting, please refer to file code CMS-1910-IFC.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (no duplicates,
please):
1. Electronically. You may submit electronic comments on specific
issues in this regulation to http://www.cms.hhs.gov/eRulemaking. Click
on the link ``Submit electronic comments on CMS regulations with an
open comment period.'' (Attachments should be in Microsoft Word,
WordPerfect, or Excel; however, we prefer Microsoft Word.)
2. By regular mail. You may mail written comments (one original and
two copies) to the following address only: Centers for Medicare &
Medicaid Services, Department of Health and Human Services, Attention:
CMS-1910-IFC, P.O. Box 8016, Baltimore, MD 21244-8016.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments (one
original and two copies) to the following address only: Centers for
Medicare & Medicaid Services, Department of Health and Human Services,
Attention: CMS-1910-IFC, Mail Stop C4-26-05, 7500 Security Boulevard,
Baltimore, MD 21244-1850.
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments (one original and two copies) before the
close of the comment period to one of the following addresses. If you
intend to deliver your comments to the Baltimore address, please call
telephone number (410) 786-7195 in advance to schedule your arrival
with one of our staff members. Room 445-G, Hubert H. Humphrey Building,
200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security
Boulevard, Baltimore, MD 21244-1850.
(Because access to the interior of the HHH Building is not readily
available to persons without Federal Government identification,
commenters are encouraged to leave their comments in the CMS drop slots
located in the main lobby of the building. A stamp-in clock is
available for persons wishing to retain a proof of filing by stamping
in and retaining an extra copy of the comments being filed.)
Comments mailed to the addresses indicated as appropriate for hand
or
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courier delivery may be delayed and received after the comment period.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: John Warren, (410) 786-3633.
SUPPLEMENTARY INFORMATION:
Submitting Comments: We welcome comments from the public on all
issues set forth in this rule to assist us in fully considering issues
and developing policies. You can assist us by referencing the file code
CMS-1910-IFC and the specific ``issue identifier'' that precedes the
section on which you choose to comment.
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following Web
site as soon as possible after they have been received: http://www.cms.hhs.gov/eRulemaking. Click on the link ``Electronic Comments on
CMS Regulations'' on that Web site to view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.
I. Background
[If you choose to comment on issues in this section, please include
the caption ``BACKGROUND'' at the beginning of your comments.]
A. Changes Based on Legislation
The Medicare Prescription Drug, Improvement, and Modernization Act
of 2003 (MMA, Pub. L. 108-173) was enacted on December 8, 2003. Section
902 of MMA of 2003 amended section 1871(a) of the Act and requires the
Secretary, in consultation with the Director of the Office of
Management and Budget, to establish and publish timelines for the
publication of Medicare final regulations based on the previous
publication of a Medicare proposed or interim final regulation. Section
902 of the MMA also states that the timelines for these regulations may
vary but shall not exceed 3 years after publication of the preceding
proposed or interim final regulation except under exceptional
circumstances. A notice implementing this provision was published in
the Federal Register on December 30, 2004 (69 FR 78442).
On February 28, 2000, we published a proposed rule in the Federal
Register (65 FR 10450) to revise certification and payment requirements
for RHCs, as required by section 4205 of the Balanced Budget Act of
1997 (BBA) (Pub. L. 105-33, enacted on August 5, 1997). On December 24,
2003, we published a final rule in the Federal Register (68 FR 74792)
to finalize that proposed rule. Because we published the proposed rule
on February 2000 and the final rule on December 2003 (more than 3 years
following the publication of the proposed rule), we will be issuing,
through separate rulemaking, a new proposed rule and subsequently, a
new final rule. However, before we publish those two rules, we are
publishing this interim final rule to suspend the implementation of the
current provisions by revising our regulations to remove those
provisions and to reinstate the provisions previously in effect before
the December 2003 final rule was published. The changes are necessary
to avoid any confusion regarding the effectiveness of the provisions of
the RHC final rule. We intend to publish a new proposed rule, which
would propose to re-adopt many of the provisions set forth under the
December 2003 final rule, followed by a new final rule informed by
public comment.
B. State Survey Agency Directors Letter
To provide clarification regarding provisions set forth in the
December 2003 final rule (effective date of rule: February 23, 2004),
we issued a letter to State Survey Agency Directors in August 2004. We
specified in the letter that we have not yet implemented certain
changes to the RHC provisions set forth in the December 2003 final
rule. We instructed State Agencies, until further notice, not to take
any action to disqualify currently approved Medicare participating RHCs
that no longer meet basic location requirements. We added that initial
RHC applicants must meet existing rural and shortage area location
requirements.
In addition, we stated that the Quality Assessment and Performance
Improvement (QAPI) program requirements were not yet mandatory.
However, we added that because a QAPI program as specified in the
December 2003 final rule will exceed the current program evaluation
requirement, any RHC that has implemented the QAPI program as specified
should be considered to be in compliance with the existing Program
Evaluation requirements.
II. Provisions of the Interim Final Rule
[If you choose to comment on issues in this section, please include
the caption ``Suspension of Regulatory Provisions'' at the beginning of
your comments.]
This interim final rule with comment period makes changes to the
RHC-related provisions under parts 405 and 491 of our regulations. This
interim final rule revises those provisions set forth in the December
2003 final rule to remove the current RHC provisions and to reinstate
policy previously in effect. This rule will not affect the provisions
that are self-implementing under the BBA or any provisions that we have
already enforced through program memoranda. We intend to publish a new
proposed rule, which would propose to re-adopt many of the provisions
set forth under the December 2003 final rule, followed by a new final
rule informed by public comment.
The suspension of the December 2003 final RHC rule will remain in
effect until we set forth provisions under the new RHC final rule. The
new proposed and final rules will identify any changes to the RHC
provisions set forth in the December 2003 final rule. The suspension
clarifies that we will not implement several of the RHC provisions
until we publish a new proposed and final RHC rule.
Regulatory Revisions
Below we describe the revisions that we are making to our current
regulations. Unless otherwise noted, we are removing the current RHC
provisions as set forth under the December 2003 rule and replacing them
with those in effect before the provisions of the December 2003 final
rule became effective. As we describe under section III of this interim
final rule, specific provisions will remain in effect and will not be
affected by regulatory revisions set forth by this rule.
Section 405.2401 Scope and Definitions.
Under paragraph (b) of this section, we revised the definition of
RHCs. We are removing the provisions that prohibit the sharing of
professional staff, space, supplies, records, and other resources with
another Medicare and Medicaid entity and provisions discussing how to
handle related costs.
Section 405.2410 Application of Part B Deductible and
Coinsurance.
Paragraphs (a) and (b) of this section describe the
responsibilities regarding
[[Page 55343]]
payment of the deductible and coinsurance under Part B.
We are revising paragraph (a) of this section to describe how we
apply the Medicare Part B deductible. We are revising paragraph (b) of
this section to revert to the language that was codified in the CFR
before publication of the December 2003 final rule.
Section 405.2462 Payment for Rural Health Clinic Services
and Federally Qualified Health Clinic Services. Hospital-Based RHCs
Payment Limit. These provisions are BBA provisions relating to the
payment limit for hospital-based RHCs. We are revising this section to
revert to previous policy regarding payment to provider-based RHCs and
FQHCs.
Section 491.2 Definitions.
We are revising this section to revert to the ``Definitions''
section that was codified in the CFR before publication of the December
2003 final rule. In the definition of ``nurse practitioner,'' we note
that the effective date referenced in paragraph (3) of the definition
would revert to the original effective date of the subpart (July 1,
1978), not the effective date of this interim final rule. In addition,
we are temporarily correcting the two incorrect cross-references in
this section. In the definition of ``Nurse practitioner,'' we are
correcting the cross reference in paragraph (3) of that definition to
read ``paragraph (2) of this definition.'' In the definition of
``Physician assistant,'' we are correcting the cross reference in
paragraph (3) of that definition to read ``paragraph (2) of this
definition.''
Section 491.3 RHC Procedures.
Provisions under paragraph (a) of this section describe our general
procedures for approving or disapproving an RHC's request to
participate in Medicare.
We are removing the provisions under paragraph (b)(1) of this
section that describe the current shortage area requirements for
participating RHCs and applicants; paragraphs (b)(2) and (b)(3) of this
section describe the procedures that RHCs must follow that have
outdated shortage area designations; and paragraph (c) under this
section describes procedures that the RHC may follow to request an
exception from disqualification when failing to meet the rural or
shortage area definition. We are not currently enforcing the policies
described under these paragraphs but we may reinstate the policy in a
future final rule.
Section 491.5 Location of Clinic.
We are revising paragraph (b) of this section that describes the
exceptions to disqualification of an approved RHC located in an area
that no longer meets the definition of a shortage or rural area.
We are also revising paragraph (d), which sets forth the criteria
for designation of shortage areas, to revert to the paragraph (d) that
was codified before publication of the December 2003 final rule.
We are re-inserting paragraph (e), which describes a medically
underserved population, to revert to the paragraph (e) that was
codified before publication of the December 2003 final rule.
We are re-inserting paragraph (f), which sets forth requirements
specific to FQHCs, to revert to the paragraph (f) that was codified
before publication of the December 2003 final rule.
Section 491.8 Staffing and Staff Responsibilities.
Set forth under the December 2003 final rule, at paragraph (a)(6)
of this section, we made an update to reflect a previous legislative
change to the amount of time non-physicians must be available to
furnish services at the clinic and a technical correction to add
``certified nurse midwife'' (CNM) to the list of health care providers
that are available to furnish patient care at least 50 percent of the
time that the RHC operates. We clarified through manual instructions
that the list of qualified RHC non-physician practitioners includes
certified nurse midwives, but this clarification had not been codified
in regulations.
We are revising paragraph (a)(6) to reinstate our previous
requirement, which does not include ``CNM'' in the list of nonphysician
providers and requires that providers be available at least ``60
percent'' of the time that the RHC operates.
We are removing the requirements under paragraph (d) of this
section that relate to waivers of RHC staffing requirements. Although
we are changing the nonphysician staffing requirement and removing the
RHC staffing waiver provision from our regulations, we are enforcing
these statutory requirements through program manuals and memoranda. In
other words, we will continue to require nonphysicians to be available
50 percent of the time and issue waivers only to currently
participating RHCs.
Section 491.11 Quality assessment and performance
improvement (QAPI).
We are revising this section to replace the current QAPI conditions
for certification for RHCs with our previous program evaluation
condition for certification.
III. Provisions That Will Remain in Effect (Refer to Provisions Under
December 2003 Final Rule)
[If you choose to comment on issues in this section, please include
the caption ``Provisions that Will Remain in Effect'' at the beginning
of your comments.]
Specific requirements under the BBA are either considered self-
implementing or have been implemented and enforced through our program
memoranda. These provisions will not be affected by this interim final
rule with comment period and will remain in effect. These provisions
are described below:
Section 405.2462 Payment for Rural Health Clinic Services
and Federally Qualified Health Clinic Services. Hospital-Based RHCs
Payment Limit. The BBA provisions relating to the payment limit for
hospital-based RHCs (section 4205(a) of the BBA, amending section
1833(f) of the Act) are not self-implementing but were implemented and
enforced through a program memorandum in 1998.
Section 491.3 RHC Procedures.
The provisions under paragraph (b)(1) of this section state that
both ``participating'' RHCs and ``applicants'' must be located in a
current shortage area, which is based on section 4205(d)(1) of the BBA,
amending section 1861(aa)(2)(A) of the Act. Although the revision
relating to RHC applicants was implemented in a memorandum to our
regional offices on February 6, 1998, the enforcement of the 3-year
provision on ``participating'' RHCs would have been implemented through
the RHC final rule. This provision could not be properly enforced until
the process and criteria for granting exceptions from RHC
disqualification are in place. Consequently, the 3-year provision as it
pertains to ``participating'' RHCs will not be enforced, and the public
will have another opportunity to comment on this provision and the new
regulatory policies established under the December 2003 final RHC rule.
The provision relating to applicants will remain in effect.
Section 491.8 Staffing and Staff Responsibilities.
At paragraph (a)(6) of this section, we made an update to reflect a
previous legislative change (section 6213(a) of OBRA 1989 amended the
staffing requirements for an RHC) to the amount of time non-physicians
must be available to furnish services at the clinic and a technical
correction to add ``certified nurse midwife'' to the list of health
care providers that are available to furnish patient care at least 50
percent of the time that the RHC
[[Page 55344]]
operates. We clarified through manual instructions that the list of
qualified RHC non-physician practitioners includes certified nurse
midwives, but this clarification was never codified in regulations. The
requirements under paragraph (d) of this section regarding waivers of
RHC staffing requirements (BBA-related), which we consider self-
implementing, were enforced through program memoranda.
IV. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, 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, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
V. Waiver of Proposed Rulemaking and Delayed Effective Date
[If you choose to comment on issues in this section, please include
the caption ``Waiver'' at the beginning of your comments.]
We ordinarily publish a notice of proposed rulemaking in the
Federal Register and invite public comment on the proposed rule. The
notice of proposed rulemaking includes a reference to the legal
authority under which the rule is proposed, and the terms and
substances of the proposed rule or a description of the subjects and
issues involved. This procedure can be waived, however, if an agency
finds good cause that a notice-and-comment procedure is impracticable,
unnecessary, or contrary to the public interest and incorporates a
statement of the finding and its reasons in the rule issued.
We find it unnecessary to undertake proposed rulemaking because
this interim final rule with comment period does not make new policy
but simply reinstates policy previously in effect relating to RHCs.
This policy was in effect before the December 2003 rule became
effective and has been subjected to public comments. Moreover, because
the 2003 rule was rendered ineffective by operation of law, we can
exercise no discretion regarding this matter and must reinstate the
regulation exactly as it existed before December 24, 2003. We intend to
publish a new proposed rule for RHCs that will be subject to proposed
rulemaking followed by a new final rule to reinstate our current RHC
policy with any necessary changes.
Further, we believe a delayed effective date is unnecessary because
this interim final rule with comment period provides additional
clarification to the RHC industry. This rule clarifies that any RHC
provisions that have already been implemented or enforced will remain
in effect and will not be impacted by the regulatory provisions that we
are revising in this interim final rule. Allowing this rule to take
effect immediately provides needed guidance and avoids any additional
confusion experienced following the publication of the December 2003
final rule. Therefore, we find good cause to waive notice-and-comment
procedures, as well as the 30-day delay in effective date.
VI. Collection of Information Requirements
This document does not impose information collection and
recordkeeping requirements. Consequently, it need not be reviewed by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1995.
VII. Regulatory Impact Statement
[If you choose to comment on issues in this section, please include
the caption ``Regulatory Impact Statement'' at the beginning of your
comments.]
We have examined the impact of this rule as required by Executive
Order 12866 (September 1993, Regulatory Planning and Review), the
Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354),
section 1102(b) of the Social Security Act, the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects, distributive impacts, and equity). A regulatory impact
analysis (RIA) must be prepared for major rules with economically
significant effects ($100 million or more in any 1 year). This rule
does not reach the economic threshold and thus is not considered a
major rule because it suspends enforcement of RHC participation
requirements.
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 $6
million to $29 million in any 1 year. Individuals and States are not
included in the definition of a small entity. We are not preparing an
analysis for the RFA because we have determined that this rule will not
have a significant economic impact on a substantial number of small
entities.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 604 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a Metropolitan
Statistical Area and has fewer than 100 beds. We are not preparing an
analysis for section 1102(b) of the Act because we have determined that
this rule will not have a significant impact on the operations of a
substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule that may result in expenditure in any 1 year by State,
local, or tribal governments, in the aggregate, or by the private
sector, of $120 million. This rule will have no consequential effect on
the governments mentioned or on the private sector.
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 requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. Since this regulation does not impose any costs on State
or local governments, the requirements of E.O. 13132 are not
applicable.
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, Medical devices, Medicare, Reporting and
recordkeeping requirements, Rural areas, and X-rays.
42 CFR Part 491
Grant programs--Health, Health facilities, Medicaid, Medicare,
Reporting and recordkeeping requirements, and Rural areas.
0
For the reasons set forth in the preamble, the Centers for Medicare &
[[Page 55345]]
Medicaid services amends 42 CFR chapter IV 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
0
1. The authority citation for part 405, continues to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
0
2. In Sec. 405.2401, in paragraph (b), revise the definition of
``rural health clinic'' to read as follows:
Sec. 405.2401 Scope and definitions.
* * * * *
(b) Definitions.
* * * * *
Rural health clinic means a facility that:
(1) Has been determined by the Secretary to meet the requirements
of section 1861(aa)(2) of the Act and part 491 of this chapter; and
(2) Has filed an agreement with the Secretary in order to provide
rural health clinic services under Medicare. (See Sec. 405.2402.)
* * * * *
0
3. Revise Sec. 405.2410 to read as follows:
Sec. 405.2410 Application of Part B deductible and coinsurance.
(a) Application of deductible. (1) Medicare payment for rural
health clinic services begins only after the beneficiary has incurred
the deductible.
(2) Medicare payment for services covered under the Federally
qualified health center benefit is not subject to the usual Part B
deductible.
(b) Application of coinsurance. (1) The beneficiary is responsible
for a coinsurance amount which cannot exceed 20 percent of the clinic's
reasonable customary charge for the covered service; and
(2)(i) The beneficiary's deductible and coinsurance liability, with
respect to any one item or service furnished by the rural health
clinic, may not exceed a reasonable amount customarily charged by the
clinic for that particular item or service.
(ii) For any one item or service furnished by a Federally qualified
health center, the coinsurance liability may not exceed 20 percent of a
reasonable amount customarily charged by the center for that particular
item or service.
0
4. Revise Sec. 405.2462 to read as follows:
Sec. 405.2462 Payment for rural health clinic and Federally qualified
health center services.
(a) Payment to provider-based rural health clinics and Federally
qualified health centers. A rural health clinic or Federally qualified
health center is paid in accordance with parts 405 and 413 of this
subchapter, as applicable, if--
(1) The clinic or center is an integral and subordinate part of a
hospital, skilled nursing facility or home health agency participating
in Medicare (that is, a provider of services); and
(2) The clinic or center is operated with other departments of the
provider under common licensure, governance and professional
supervision.
(b) Payment to independent rural health clinics and freestanding
Federally qualified health centers. (1) All other clinics and centers
will be paid on the basis of an all-inclusive rate for each beneficiary
visit for covered services. This rate will be determined by the
intermediary, in accordance with this subpart and general instructions
issued by CMS.
(2) The amount payable by the intermediary for a visit will be
determined in accordance with paragraphs (b)(3) and (4) of this
section.
(3) Federally qualified health centers. For Federally qualified
health center visits, Medicare will pay 80 percent of the all-inclusive
rate since no deductible is applicable to Federally qualified health
center services.
(4) Rural health clinics. (i) If the deductible has been fully met
by the beneficiary prior to the rural health clinic 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 clinic's reasonable customary
charge for the services that is applied to the deductible is--
(A) Less than the all-inclusive rate, the amount applied to the
deductible will be subtracted from the all-inclusive rate and 80
percent of the remainder, if any, will be paid to the clinic;
(B) Equal to or exceeds the all-inclusive rate, no payment will be
made to the clinic.
(5) To receive payment, the clinic or center must follow the
payment procedures specified in Sec. 410.165 of this chapter.
(6) Payment for treatment of mental psychoneurotic or personality
disorders is subject to the limitations on payment in Sec. 410.155(c).
PART 491--CERTIFICATION OF CERTAIN HEALTH FACILITIES
0
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).
0
2. Revise Sec. 491.2 to read as follows:
Sec. 491.2 Definitions.
As used in this subpart, unless the context indicates otherwise:
Direct services means services provided by the clinic's staff.
FQHC means an entity as defined in Sec. 405.2401(b).
Nurse practitioner means a registered professional nurse who is
currently licensed to practice in the State, who meets the State's
requirements governing the qualifications of nurse practitioners, and
who meets one of the following conditions:
(1) Is currently certified as a primary care nurse practitioner by
the American Nurses' Association or by the National Board of Pediatric
Nurse Practitioners and Associates; or
(2) Has satisfactorily completed a formal 1 academic year
educational program that:
(i) Prepares registered nurses to perform an expanded role in the
delivery of primary care;
(ii) Includes at least 4 months (in the aggregate) of classroom
instruction and a component of supervised clinical practice; and
(iii) Awards a degree, diploma, or certificate to persons who
successfully complete the program; or
(3) Has successfully completed a formal educational program (for
preparing registered nurses to perform an expanded role in the delivery
of primary care) that does not meet the requirements of paragraph (2)
of this definition, and has been performing an expanded role in the
delivery of primary care for a total of 12 months during the 18-month
period immediately preceding the effective date of this subpart.
Physician means a doctor of medicine or osteopathy legally
authorized to practice medicine or surgery in the State.
Physician assistant means a person who meets the applicable State
requirements governing the qualifications for assistants to primary
care physicians, and who meets at least one of the following
conditions:
(1) Is currently certified by the National Commission on
Certification of Physician Assistants to assist primary care
physicians; or
[[Page 55346]]
(2) Has satisfactorily completed a program for preparing
physician's assistants that:
(i) Was at least 1 academic year in length;
(ii) Consisted of supervised clinical practice and at least 4
months (in the aggregate) of classroom instruction directed toward
preparing students to deliver health care; and
(iii) Was accredited by the American Medical Association's
Committee on Allied Health Education and Accreditation; or
(3) Has satisfactorily completed a formal educational program (for
preparing physician assistants) that does not meet the requirements of
paragraph (2) of this definition and assisted primary care physicians
for a total of 12 months during the 18-month period that ended on
December 31, 1986.
Rural area means an area that is not delineated as an urbanized
area by the Bureau of the Census.
Rural health clinic or clinic means a clinic that is located in a
rural area designated as a shortage area, is not a rehabilitation
agency or a facility primarily for the care and treatment of mental
diseases, and meets all other requirements of this subpart.
Shortage area means a defined geographic area designated by the
Department as having either a shortage of personal health services
(under section 1302(7) of the Public Health Service Act) or a shortage
of primary medical care manpower (under section 332 of that Act).
Secretary means the Secretary of Health and Human Services, or any
official to whom he has delegated the pertinent authority.
0
3. Revise Sec. 491.3 as follows:
Sec. 491.3 Certification procedures.
A rural health clinic will be certified for participation in
Medicare in accordance with subpart S of 42 CFR part 405. The Secretary
will notify the State Medicaid agency whenever he has certified or
denied certification under Medicare for a prospective rural health
clinic in that State. A clinic certified under Medicare will be deemed
to meet the standards for certification under Medicaid.
0
4. In Sec. 491.5, revise paragraphs (b) and (d) and add paragraphs (e)
and (f) to read as follows:
Sec. 491.5 Location of clinic.
* * * * *
(b) Exceptions. (1) CMS does not disqualify an RHC approved under
this subpart if the area in which it is located subsequently fails to
meet the definition of a rural, shortage area.
(2) A private, nonprofit facility that meets all other conditions
of this subpart except for location in a shortage area will be
certified if, on July 1, 1977, it was operating in a rural area that is
determined by the Secretary (on the basis of the ratio of primary care
physicians to the general population) to have an insufficient supply of
physicians to meet the needs of the area served.
(3) Determinations on these exceptions will be made by the
Secretary upon application by the facility.
* * * * *
(d) Criteria for designation of shortage areas. (1) The criteria
for determination of shortage of personal health services (under
section 1302(7) of the Public Health Services Act), are:
(i) The ratio of primary care physicians practicing within the area
to the resident population;
(ii) The infant mortality rate;
(iii) The percent of the population 65 years of age or older; and
(iv) The percent of the population with a family income below the
poverty level.
(2) The criteria for determination of shortage of primary medical
care manpower (under section 332(a)(1)(A) of the Public Health Services
Act) are:
(i) The area served is a rational area for the delivery of primary
medical care services;
(ii) The ratio of primary care physicians practicing within the
area to the resident population; and
(iii) The primary medical care manpower in contiguous areas is
overutilized, excessively distant, or inaccessible to the population in
this area.
(e) Medically underserved population. A medically underserved
population includes the following:
(1) A population of an urban or rural area that is designated by
PHS as having a shortage of personal health services.
(2) A population group that is designated by PHS as having a
shortage of personal health services.
(f) Requirements specific to FQHCs. An FQHC approved for
participation in Medicare must meet one of the following criteria:
(1) Furnish services to a medically underserved population.
(2) Be located in a medically underserved area, as demonstrated by
an application approved by PHS.
0
5. Amend Sec. 491.8 by--
0
A. Revising paragraph (a).
0
B. Removing paragraph (d).
The revisions read as follows:
Sec. 491.8 Staffing and staff responsibilities.
(a) Staffing. (1) The clinic or center has a health care staff that
includes one or more physicians. Rural health clinic staffs must also
include one or more physician's assistants or nurse practitioners.
(2) The physician member of the staff may be the owner of the rural
health clinic, an employee of the clinic or center, or under agreement
with the clinic or center to carry out the responsibilities required
under this section.
(3) The physician assistant, nurse practitioner, nurse-midwife,
clinical social worker, or clinical psychologist member of the staff
may be the owner or an employee of the clinic or center, or may furnish
services under contract to the center.
(4) The staff may also include ancillary personnel who are
supervised by the professional staff.
(5) The staff is sufficient to provide the services essential to
the operation of the clinic or center.
(6) A physician, nurse practitioner, physician assistant, nurse-
midwife, clinical social worker, or clinical psychologist is available
to furnish patient care services at all times the clinic or center
operates. In addition, for rural health clinics, a nurse practitioner
or a physician assistant is available to furnish patient care services
at least 60 percent of the time the clinic operates.
* * * * *
0
6. Revise Sec. 491.11 to read as follows:
Sec. 491.11 Program evaluation.
(a) The clinic or center carries out, or arranges for, an annual
evaluation of its total program.
(b) The evaluation includes review of:
(1) The utilization of clinic or center services, including at
least the number of patients served and the volume of services;
(2) A representative sample of both active and closed clinical
records; and
(3) The clinic's or center's health care policies.
(c) The purpose of the evaluation is to determine whether:
(1) The utilization of services was appropriate;
(2) The established policies were followed; and
(3) Any changes are needed.
(d) The clinic or center staff considers the findings of the
evaluation and takes corrective action if necessary.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
[[Page 55347]]
Dated: March 30, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
Approved: June 12, 2006.
Michael O. Leavitt,
Secretary.
[FR Doc. 06-7886 Filed 9-21-06; 8:45 am]
BILLING CODE 4120-01-P