Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 55341 

Authority: Secs. 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 

1395(hh)). 

Subpart F—Conditions of 

Participation: Critical Access Hospitals 

(CAHs) 

■ 16. Section 485.623 is amended as 

follows: 

■ A. Paragraph (d)(7)(iii) is revised. 

■ B. Paragraph (d)(7)(iv) is amended by 

removing the last sentence. 

■ C. Paragraph (d)(7)(iv) is further 

amended by removing the period at the 

end of the paragraph and adding in its 

place ‘‘; and’’. 

■ D. Paragraph (d)(7)(v) is added. 

The revisions read as follows: 

§ 485.623 Condition of participation: 

Physical plant and environment. 

* * * * * 

(d) * * * 

(7) * * * 

(iii) The dispensers are installed in a 

manner that adequately protects against 

inappropriate access; 

* * * * * 

(v) The dispensers are maintained in 

accordance with dispenser 

manufacturer guidelines. 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program) 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: February 8, 2006. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Approved: May 31, 2006. 

Michael O. Leavitt, 

Secretary. 

[FR Doc. 06–7885 Filed 9–21–06; 8:45 am] 

BILLING CODE 4120–01–P 

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. 

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 selfimplementing 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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55342 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 

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 RHCrelated 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 


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Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 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 


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55344 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 

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 selfimplementing, 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. 

■ For the reasons set forth in the 

preamble, the Centers for Medicare & 


rwilkins on PROD1PC63 with RULES_1
Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 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 

■ 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). 

■ 2. In § 405.2401, in paragraph (b), 

revise the definition of ‘‘rural health 

clinic’’ to read as follows: 

§ 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 § 405.2402.) 

* * * * * 

■ 3. Revise § 405.2410 to read as 

follows: 

§ 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. 

■ 4. Revise § 405.2462 to read as 

follows: 

§ 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 allinclusive rate, no payment will be made 

to the clinic. 

(5) To receive payment, the clinic or 

center must follow the payment 

procedures specified in § 410.165 of this 

chapter. 

(6) Payment for treatment of mental 

psychoneurotic or personality disorders 

is subject to the limitations on payment 

in § 410.155(c). 

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. Revise § 491.2 to read as follows: 

§ 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 

§ 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 


rwilkins on PROD1PC63 with RULES_1
55346 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 

(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. 

■ 3. Revise § 491.3 as follows: 

§ 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. 

■ 4. In § 491.5, revise paragraphs (b) and 

(d) and add paragraphs (e) and (f) to 

read as follows: 

§ 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. 

■ 5. Amend § 491.8 by—

■ A. Revising paragraph (a). 

■ B. Removing paragraph (d). 

The revisions read as follows: 

§ 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. 

* * * * * 

■ 6. Revise § 491.11 to read as follows: 

§ 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) 


rwilkins on PROD1PC63 with RULES_1
Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 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 

DEPARTMENT OF TRANSPORTATION 

Office of the Secretary 

49 CFR Part 40 

[Docket OST–2006–24112] 

RIN 2105–AD57 

Procedures for Transportation 

Workplace Drug and Alcohol Testing 

Programs: Corrections to the Federal 

Register 

AGENCY: Office of the Secretary, DOT. 

ACTION: Final rule; correction. 

SUMMARY: The Department of 

Transportation published in the Federal 

Register of August 23, 2006, a final rule 

(effective September 22, 2006) which 

added state-licensed or certified 

marriage and family therapists to the list 

of credentialed professionals eligible to 

serve as substance abuse professionals 

under subpart O of 49 CFR part 40. The 

final rule also made a series of technical 

amendments to its drug and alcohol 

testing procedural rule. This notice 

corrects a misspelling in the final rule 

and adds text that was discussed in the 

preamble but omitted in the rule text. 

DATES: This correction is effective 

September 22, 2006. 

FOR FURTHER INFORMATION CONTACT: 

Bohdan Baczara, Office of Drug and 

Alcohol Policy and Compliance, 400 

Seventh Street, SW., Washington, DC 

20590; 202–366–3784 (voice), 202–366–

3897 (fax), or bohdan.baczara@dot.gov 

(e-mail). 

SUPPLEMENTARY INFORMATION: The Office 

of Drug & Alcohol Policy & Compliance 

published a final rule in the Federal 

Register (71 FR 49382). In this rule, 

there was a typographical error and an 

omission of text. This notice will correct 

these oversights. 

■ In rule FR Doc. E6–13956 published 

on August 23, 2006 (71 FR 49382) make 

the following corrections. 

§ 40.3 [Corrected] 

■ 1. On page 49384, in the second 

column, third line, replace the word 

‘‘Material’’ with ‘‘Materials’’. 

§ 40.281 [Corrected] 

■ 2. On page 49384, in the third column, 

add a new instruction 10a following the 

amendment to § 40.281 to read as 

follows: 

■ ‘‘10a. Section 40.281 is further 

amended in the introductory text after 

the word ‘drug’ by adding the text ‘and 

alcohol’.’’

Dated: September 14, 2006. 

Jim L. Swart, 

Acting Director, Office of Drug and Alcohol 

Policy and Compliance, United States 

Department of Transportation. 

[FR Doc. E6–15617 Filed 9–21–06; 8:45 am] 

BILLING CODE 4910–9X–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 679 

[Docket No. 060216045–6045–01; I.D. 

091806A] 

Fisheries of the Exclusive Economic 

Zone Off Alaska; Adjustment of Pacific 

Cod Total Allowable Catch Amount in 

the Bering Sea and Aleutian Islands 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; inseason 

adjustment; request for comments. 

SUMMARY: NMFS is adjusting the 2006 

Pacific cod total allowable catch (TAC) 

amount in the Bering Sea and Aleutian 

Islands Management Area (BSAI). This 

action is necessary to allow harvest of 

Pacific cod that will not be harvested 

under the State of Alaska’s guideline 

harvest level (GHL) for the Aleutian 

Islands subarea state waters Pacific cod 

fishery. This action is consistent with 

the goals and objectives of the Fishery 

Management Plan for Groundfish of the 

BSAI (FMP). 

DATES: Effective September 19, 2006, 

through 2400 hrs, Alaska local time 

(A.l.t.), December 31, 2007. 

Comments must be received at the 

following address no later than 4:30 

p.m., A.l.t., October 4, 2006. 

ADDRESSES: Send comments to Sue 

Salveson, Assistant Regional 

Administrator, Sustainable Fisheries 

Division, Alaska Region, NMFS, Attn: 

Ellen Walsh. Comments may be 

submitted by: 

• Mail to: P.O. Box 21668, Juneau, AK 

99802; 

• Hand delivery to the Federal 

Building, 709 West 9th Street, Room 

420A, Juneau, Alaska; 

• FAX to 907–586–7557; 

• E-mail to statepcodrelb@noaa.gov 

and include in the subject line of the email comment the document identifier: 

statepcodrelb (E-mail comments, with or 

without attachments, are limited to 5 

megabytes); or 

• Webform at the Federal eRulemaking 

Portal: http://www.regulations.gov. 

Follow the instructions at that site for 

submitting comments. 

FOR FURTHER INFORMATION CONTACT: Josh 

Keaton, 907–586–7228. 

SUPPLEMENTARY INFORMATION: NMFS 

manages the groundfish fishery in the 

BSAI according to the FMP prepared by 

the North Pacific Fishery Management 

Council (Council) under authority of the 

Magnuson-Stevens Fishery 

Conservation and Management Act. 

Regulations governing fishing by U.S. 

vessels in accordance with the FMP 

appear at subpart H of 50 CFR part 600 

and 50 CFR part 679. 

The 2006 and 2007 final harvest 

specifications for groundfish in the 

BSAI (71 FR 10894, March 3, 2006) 

established the 2006 and 2007 Pacific 

cod acceptable biological catches (ABC) 

as 194,000 metric tons (mt) and 148,000 

mt, respectively. The TACs were set 

equal to the ABCs for Pacific cod in the 

BSAI. On March 14, 2006, NMFS 

reduced the Pacific cod TAC in the 

BSAI after the Alaska Department of 

Fish and Game (ADF&G) announced by 

emergency regulation a Pacific cod GHL, 

west of 170 degrees west longitude in 

the Aleutian Islands subarea, equal to 

three percent of the Pacific cod ABC in 

the BSAI (71 FR 13777, March 17, 

2006). 

On August 28, 2006, ADF&G 

announced the closure of the 2006 state 

waters Pacific cod fishery, west of 170 

degrees west longitude in the Aleutian 

Islands subarea, effective 11:59 a.m. 

A.l.t., September 1, 2006. As of 

September 1, 2006, the Administrator, 

Alaska Region, NMFS, (Regional 

Administrator) has determined that 

ADF&G is making available 1,588 mt of 

unharvested Pacific cod from the 

Aleutian Islands state waters Pacific cod 

fishery to the federal Pacific cod 

fisheries. As a result, the Regional 

Administrator has determined, using the 

best scientific information available, 

that the current 2006 TAC is incorrectly 

specified because the transfer of 

unharvested state waters GHL in the 

Aleutian Islands subarea to the federally 

managed fisheries requires an increase 

to the 2006 TAC of Pacific cod in the 

BSAI. This action will not exceed the 


rwilkins on PROD1PC63 with RULES_1