43956 Federal Register / Vol. 69, No. 141 / Friday, July 23, 2004 / Proposed Rules 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[CA 289–0451b; FRL–7784–1] 

Revisions to the California State 

Implementation Plan, Monterey Bay 

Unified and Santa Barbara Air 

Pollution Control Districts

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA is proposing to approve 

revisions to the Monterey Bay Unified 

Air Pollution Control District 

(MBUAPCD) and Santa Barbara County 

Air Pollution Control District 

(SBCAPCD) portions of the California 

State Implementation Plan (SIP). These 

revisions concern definitions. We are 

proposing to approve local rules to 

regulate these emission sources under 

the Clean Air Act as amended in 1990 

(CAA or the Act).

DATES: Any comments on this proposal 

must arrive by August 23, 2004.

ADDRESSES: Send comments to Andy 

Steckel, Rulemaking Office Chief (AIR–

4), U.S. Environmental Protection 

Agency, Region IX, 75 Hawthorne 

Street, San Francisco, CA 94105–3901 

or e-mail to steckel.andrew@epa.gov, or 

submit comments at http://

www.regulations.gov.

You can inspect copies of the 

submitted SIP revisions, EPA’s technical 

support documents (TSDs), and public 

comments at our Region IX office during 

normal business hours by appointment. 

You may also see copies of the 

submitted SIP revisions by appointment 

at the following locations:

California Air Resources Board, 

Stationary Source Division, Rule 

Evaluation Section, 1001 ‘‘I’’ Street, 

Sacramento, CA 95814

Monterey Bay Unified Air Pollution 

Control District, 24580 Silver Cloud 

Ct., Monterey, CA 93940–6536 

Santa Barbara County Air Pollution 

Control District, 260 North San 

Antonio Road, Suite A, Santa Barbara, 

CA 93110–1315

A copy of the rule may also be 

available via the Internet at http://

www.arb.ca.gov/drdb/drdbltxt.htm.

Please be advised that this is not an EPA 

Web site and may not contain the same 

version of the rule that was submitted 

to EPA.

FOR FURTHER INFORMATION CONTACT:

Cynthia G. Allen, EPA Region IX, (415) 

947–4120, allen.cynthia@epa.gov.

SUPPLEMENTARY INFORMATION: This 

proposal addresses the following local 

rules: MBUAPCD Rule 101 and 

SBCAPCD Rule 102. In the Rules and 

Regulations section of this Federal 

Register, we are approving these local 

rules in a direct final action without 

prior proposal because we believe these 

SIP revisions are not controversial. If we 

receive adverse comments, however, we 

will publish a timely withdrawal of the 

direct final rule and address the 

comments in subsequent action based 

on this proposed rule. Please note that 

if we receive adverse comment on an 

amendment, paragraph, or section of 

this rule and if that provision may be 

severed from the remainder of the rule, 

we may adopt as final those provisions 

of the rule that are not the subject of an 

adverse comment. 

We do not plan to open a second 

comment period, so anyone interested 

in commenting should do so at this 

time. If we do not receive adverse 

comments, no further activity is 

planned. For further information, please 

see the direct final action.

Dated: June 15, 2004. 

Wayne Nastri, 

Regional Administrator, Region IX.

[FR Doc. 04–16567 Filed 7–22–04; 8:45 am] 

BILLING CODE 6560–50–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 402 

[CMS–6146–P] 

RIN 0938–AL53 

Medicare Program; Revised Civil 

Money Penalties, Assessments, 

Exclusions, and Related Appeals 

Procedures

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS.

ACTION: Proposed rule.

SUMMARY: This proposed rule would 

establish the procedures for imposing 

exclusions for certain violations of the 

Medicare program. These procedures 

are based on the procedures that the 

Office of Inspector General has 

published for civil money penalties, 

assessments, and exclusions under their 

delegated authority. These regulations 

would protect beneficiaries from health 

care providers and entities found in 

noncompliance with Medicare rules and 

regulations and would otherwise 

improve the safeguard provisions under 

the Medicare statute.

DATES: To be assured consideration, 

comments must be received at the 

appropriate address, as provided below, 

no later than 5 p.m. on September 21, 

2004.

ADDRESSES: In commenting, please refer 

to file code CMS–6146–P. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission or e-mail. Mail written 

comments (one original and three 

copies) to the following address only: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Attention: CMS–6146–

P, P.O. Box 8013, Baltimore, MD 21244–

8013. 

Please allow sufficient time for mailed 

comments to be timely received in the 

event of delivery delays. 

If you prefer, you may deliver (by 

hand or courier) your written comments 

(one original and three copies) to one of 

the following addresses: Room 443–G, 

Hubert H. Humphrey Building, 200 

Independence Avenue, SW., 

Washington, DC 20201, or Room C5–14–

03, 7500 Security Boulevard, Baltimore, 

MD 21244–1850.

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

could be considered late. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Joel 

Cohen, (410) 786–3349.

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–6146–P 

and the specific ‘‘issue identifier’’ that 

precedes the section on which you 

choose to comment. 

Inspection of Public Comments:

Comments received timely will be 

available for public inspection as they 

are processed, 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 (410) 786–7197. 

Copies: To order copies of the Federal 

Register containing this document, send 

your request to: New Orders, 

Superintendent of Documents, P.O. Box 

371954, Pittsburgh, PA 15250–7954. 

Specify the date of the issue requested 

and enclose a check or money order 

Federal Register / Vol. 69, No. 141 / Friday, July 23, 2004 / Proposed Rules 43957

payable to the Superintendent of 

Documents, or enclose your Visa or 

Master Card number and expiration 

date. Credit card orders can also be 

placed by calling the order desk at (202) 

512–1800 or by faxing to (202) 512–

2250. The cost for each copy is $10. As 

an alternative, you can view and 

photocopy the Federal Register

document at most libraries designated 

as Federal Depository Libraries and at 

many other public and academic 

libraries throughout the country that 

receive the Federal Register. 

This Federal Register document is 

also available from the Federal Register 

online database through GPO Access, a 

service of the U.S. Government Printing 

Office. The Web site address is: http://

www.access.gpo.gov/nara/index.html.

I. Background 

[If you choose to comment on issues 

in this section, please include the 

caption ‘‘Background’’ at the beginning 

of your comments.]

Section 2105 of the Omnibus Budget 

Reconciliation Act of 1981 (Pub. L. 97–

35) added section 1128A to the Social 

Security Act (the Act) to authorize the 

Secretary of Health and Human Services 

to impose civil money penalties, 

assessments, and/or exclusion from the 

Medicare program for certain health 

care facilities, practitioners, suppliers or 

other entities under prescribed 

circumstances. Exclusion provides the 

ultimate enforcement tool for agencies 

attempting to establish compliance with 

legal and program standards, and is 

used in addition to potential civil, 

criminal, and/or administrative 

proceedings. 

Since 1981, the Congress has 

significantly increased both the number 

and types of circumstances under which 

the Secretary may impose an exclusion 

of a provider or an entity from the 

Medicare and State health care 

programs. The Secretary has delegated 

the authority for these provisions to 

either the Office of Inspector General 

(OIG) or the Centers for Medicare & 

Medicaid Services (CMS) (59 FR 52967, 

October 20, 1994). The exclusion 

authorities delegated to the OIG address 

fraud, misrepresentation, or 

falsification, while those that address 

noncompliance with programmatic or 

regulatory requirements are delegated to 

CMS. However, the OIG has the 

authority to impose an exclusion and to 

prosecute cases involving exclusions 

that were delegated to CMS if CMS and 

the OIG jointly determine it to be in the 

interest of economy, efficiency, or 

effective coordination of activities. The 

determination may be made either on a 

case-by-case basis, or for all cases 

brought under a particular listed 

authority. 

On December 14, 1998, we published 

a final rule in the Federal Register (63 

FR 68687), delineating the procedures 

for pursuing civil money penalties 

(CMPs) and assessments. That final rule 

added a new part 402 to title 42, chapter 

IV of the Code of Federal Regulations 

(CFR) to incorporate our CMP and 

assessment authorities. We did not 

address exclusions in that final rule, but 

did reserve subpart C to incorporate this 

information at a future date. 

In the December 14, 1998 rule, we 

indicated that our procedures for 

imposing the CMPs and assessment 

authorities delegated to CMS were based 

on the procedures that the OIG has 

delineated in 42 CFR part 1003. We also 

made the OIG’s hearing and appeal 

procedures set forth in 42 CFR part 1005 

effective for the CMP, assessment, and 

exclusion authorities delegated to CMS. 

II. Provisions of the Proposed Rule

This proposed rule would amend part 

402, subpart C, Exclusions, to 

incorporate the rules concerning 

exclusions associated with the CMP 

violations identified in part 402. 

Subpart C contains the general 

requirements and procedures that are 

common to the imposition of an 

exclusion from Medicare, Medicaid, 

and, where applicable, other Federal 

health care programs. These regulations 

would not materially impact the hearing 

and appeal procedures currently 

available to any person on whom we 

could impose an exclusion. 

Specifically, we are proposing to add 

the following provisions to subpart C: 

• Section 402.200, Basis and purpose. 

[If you choose to comment on issues 

in this section, please include the 

caption ‘‘Basis and purpose’’ at the 

beginning of your comments.] 

This section provides the basis and 

purpose for the imposition of an 

exclusion from Medicare, Medicaid, 

and, where applicable, other Federal 

health care programs for noncompliance 

with the respective provisions of the Act 

specified in § 402.1(e). This subpart also 

sets forth the appeal rights of persons 

subject to exclusion, and the procedures 

for reinstatement following exclusion. 

This subpart is based on § 1003.102, 

§ 1003.105, § 1003.107, and § 1003.109 

of the OIG’s regulations. 

• Section 402.205, Length of 

exclusion. 

[If you choose to comment on issues 

in this section, please include the 

caption ‘‘Length of exclusion’’ at the 

beginning of your comments.] 

This section describes the duration of 

exclusion from Medicare, Medicaid, 

and, where applicable, other Federal 

health care programs for the applicable 

violation. Currently, there are four 

general categories for which violations 

may cause exclusions. These categories 

involve non-compliance with 

assignment billings, non-compliance 

with charge or service limits, failure to 

provide information or improperly 

providing information, or noncompliance with Medigap or Medicare 

Select. Some exclusion provisions 

provide that the exclusion is imposed in 

accordance with section 1842(j)(2) of the 

Act. Section 1842(j)(2) provides for 

exclusion from participation in the 

programs under the Act. These 

exclusions may not exceed 5 years. For 

these exclusion provisions, CMS 

proposes to use its discretion to set a 

duration for the exclusion, up to 5 years, 

after considering aggravating and 

mitigating circumstances as described in 

this proposed rule. By contrast, many 

other exclusion provisions extend to all 

Federal health care programs, and do 

not address the minimum or maximum 

duration of the exclusion, but instead 

simply refer to applying the provisions 

of section 1128A of the Act, or section 

1128(c) of the Act for imposition of the 

exclusion. However, neither section 

1128A, nor section 1128(c) addresses 

the specific duration of an exclusion for 

any of the title XVIII exclusion 

provisions described in this proposed 

rule. Therefore, where the duration of 

an exclusion is not specifically 

addressed by statute for a specific 

exclusion provision, CMS proposes to 

use its discretion to apply a time period 

it believes is justified, taking into 

account appropriate aggravating and 

mitigating factors as described in this 

proposed rule. 

While several provisions of title 18 of 

the Act refer on their face only to CMPs, 

they also make cross-references to 

section 1128A of the Act, from which 

we assert that our exclusion authority 

derives. For example, several provisions 

within section 1882 of the Act refer to 

CMPs. Each of these provisions 

incorporates by reference portions of 

section 1128A, articulating with precise 

specificity which provisions of section 

1128A are applicable. In each case, this 

includes section 1128A’s exclusion 

authority found in section 1877, though 

there the exclusion authority is made 

even more clear with the term 

‘‘exclusion’’ being found in the section 

heading. The applicable provision of 

section 1128A is that provision’s last 

sentence, explicitly made applicable to 

all the foregoing, which provides that 

the Secretary ‘‘may make a 

determination in the same [CMP] 

43958 Federal Register / Vol. 69, No. 141 / Friday, July 23, 2004 / Proposed Rules 

proceeding to exclude the person from 

participation in * * * Federal health 

care programs * * *’’

• Section 402.208, Factors considered 

in determining whether to exclude, and 

the length of exclusion.

[If you choose to comment on issues 

in this section, please include the 

caption ‘‘Factors considered’’ at the 

beginning of your comments.] 

The statute specifies the grounds for 

imposition of the various exclusions, 

but offers little detail regarding the 

adjudicatory processes inherent in 

administering them. Instead, the statute 

vests CMS with broad administrative 

discretion. We are sensitive to the fact 

that the nature of the grounds for 

imposition of exclusions vary widely.

This section describes the specific 

details of the aggravating or mitigating 

circumstances that may be considered. 

This section is based on corresponding 

sections of 42 CFR parts 1001 and 1003. 

We note that our application of 

aggravating and mitigating factors flows 

both as a natural result of a statutory 

scheme that contemplates exclusions of 

varying lengths, as well as the 

Secretary’s rulemaking authority 

specified in section 1871 of the Act. 

• Section 402.209, Scope and effect of 

exclusion.

[If you choose to comment on issues 

in this section, please include the 

caption ‘‘Scope and effect’’ at the 

beginning of your comments.] 

This section describes the general 

scope and effect of an exclusion. 

Generally, an excluded provider or 

supplier may not directly or indirectly 

submit claims, or cause claims to be 

submitted, to the Medicare program. 

Providers who submit, or cause to be 

submitted, claims during the course of 

an exclusion risk other possible 

sanctions, including criminal and civil 

liability. Medicare will not pay claims 

for beneficiaries who elect to see 

excluded providers, except, perhaps, for 

the first claim, which will be 

accompanied by a notification to the 

beneficiary that the provider/supplier 

has been excluded from participation in 

Medicare and that no further Medicare 

payments will be made on the 

beneficiary’s behalf. This section is 

based on § 1001.1901. We note that in 

§ 402.209(b)(3), whereas in some cases 

the maximum exclusion time limit may 

preclude us from applying the specified 

prohibited conduct as the basis for 

denying reinstatement to the Medicare 

program, the fact that an excluded 

provider has engaged in such prohibited 

conduct may give rise to a new 

exclusion action by the initiating agency 

(CMS or OIG), the practical effect of 

which would be to deny reinstatement 

into the Medicare program. 

• Section 402.210, Notice of 

exclusion.

[If you choose to comment on issues 

in this section, please include the 

caption ‘‘Notice of exclusion’’ at the 

beginning of your comments.] 

This section describes the contents of 

the respective notices, and, specifically 

the timing for release of (a) the written 

notice of intent to exclude (that is, the 

proposed determination), and (b) the 

written notice of exclusion. At a 

minimum, the written notice of intent to 

exclude provides the person with such 

information as to the reason why the 

person is noncompliant with the statute, 

the length of the proposed exclusion, 

and instructions for responding to this 

notice, including providing argument to 

the exclusion for the agency to consider. 

The written notice to exclude is sent to 

the person in the same manner as the 

written notice of intent to exclude if the 

agency determines the exclusion is 

warranted. This notice will also provide 

the person with information on their 

appeal rights to the exclusion. This 

section is based on the notices provided 

by the OIG in § 1001.2001, § 1001.2002, 

§ 1001.2003, and § 1003.109. 

• Section 402.212, Response to notice 

of proposed exclusion.

[If you choose to comment on issues 

in this section, please include the 

caption ‘‘Response to notice’’ at the 

beginning of your comments.] 

This section describes the general 

process and procedure for the 

respondent to follow when presenting 

an oral or written response to the notice 

of intent to exclude (that is, the 

proposed determination). The agency 

will accept for consideration any 

supportive information the respondent 

provides. The agency does not limit nor 

suggest what type of information should 

be presented. The burden to present 

convincing information is left to the 

discretion of the respondent. This 

section is based on the process and 

procedures delineated by the OIG in 

§ 1003.109. However, to encourage 

timely communication between the 

respondent and the initiating agency, 

we have added an additional element 

whereby the initiating agency will 

contact the respondent within 15 days 

of receipt of the respondent’s request to 

establish a mutually agreed upon time 

and place for the hearing of oral 

arguments.

• Section 402.214, Appeal of 

exclusion.

[If you choose to comment on issues 

in this section, please include the 

caption ‘‘Appeal of exclusion’’ at the 

beginning of your comments.] 

This section describes the general 

appeal process (as referenced in § 1005) 

for requesting a hearing before an 

administrative law judge and details the 

required elements of the written request 

for appeal. Generally, the elements of 

the written request must include the 

basis for the disagreement with the 

exclusion, the general basis for the 

defense of the respondent, reasons why 

the proposed length of exclusion should 

be modified. This section is based on 

§ 1001.2003 and § 1001.2007. 

• Section 402.300, Request for 

reinstatement.

[If you choose to comment on issues 

in this section, please include the 

caption ‘‘Request for reinstatement’’ at 

the beginning of your comments.] 

In proposed § 402.300, we discuss the 

request for reinstatement. In 

§ 402.300(a), we describe the written 

request for reinstatement. We discuss 

that an excluded person may submit a 

written request for reinstatement to the 

initiating agency no sooner than 120 

days prior to the terminal date of 

exclusion as specified in the notice of 

exclusion. The written request for 

reinstatement would be required to 

include documentation demonstrating 

that the person has met the standards 

set forth in § 402.302. We also state that 

obtaining or reactivating a Medicare 

provider number (or equivalent) would 

not constitute reinstatement. 

Section 402.300(b) discusses that, 

upon receipt of a written request for 

reinstatement, the initiating agency may 

require the person to furnish additional, 

specific information, and authorization 

to obtain information from private 

health insurers, peer review 

organizations, and others as necessary to 

determine whether reinstatement is 

granted. 

In § 402.300(c), we discuss that failure 

to submit a written request for 

reinstatement and/or to furnish the 

required information or authorization 

would result in the continuation of the 

exclusion, unless the exclusion had 

been in effect for 5 years. In that case, 

reinstatement would be automatic. 

Section 402.300(d) discusses that, if a 

period of exclusion is reduced on 

appeal (regardless of whether further 

appeal is pending), the excluded person 

would be permitted to request and 

apply for reinstatement within 120 days 

of the expiration of the reduced 

exclusion period. A written request for 

the reinstatement would include the 

same standards as noted in paragraph 

(b) of this section. This section is based 

on § 1001.3001. 

• Section 402.302, Basis for 

reinstatement.

Federal Register / Vol. 69, No. 141 / Friday, July 23, 2004 / Proposed Rules 43959

[If you choose to comment on issues 

in this section, please include the 

caption ‘‘Basis for reinstatement’’ at the 

beginning of your comments.] 

In § 402.302, we discuss that the 

initiating agency would authorize 

reinstatement if the agency determined 

that-

(1) The period of exclusion had 

expired; 

(2) There were reasonable assurances 

that the types of actions that formed the 

basis for the original exclusion did not 

recur and would not recur; and 

(3) There is no additional basis under 

title XVIII of the Act that would justify 

the continuation of the exclusion. 

We are also discussing that the 

initiating agency would not authorize 

reinstatement if it determined that 

submitting claims or causing claims to 

be submitted or payments to be made by 

the Medicare program for items or 

services furnished, ordered, or 

prescribed, would serve as a basis for 

denying reinstatement. This section 

would apply regardless of whether the 

excluded person had obtained a 

Medicare provider number (or 

equivalent), either as an individual or as 

a member of a group, before being 

reinstated. 

In making a determination regarding 

reinstatement, the initiating agency 

would consider—(1) The conduct of the 

excluded person occurring before the 

date of the notice of the exclusion, if 

that conduct was not known to the 

initiating agency at the time of the 

exclusion; (2) the conduct of the 

excluded person after the date of the 

exclusion; (3) whether all fines and all 

debts due and owing (including 

overpayments) to any Federal, State, or 

local government that relate to 

Medicare, Medicaid, or, where 

applicable, any Federal, State, or local 

health care program were paid in full, 

or satisfactory arrangements were made 

to fulfill these obligations; (4) whether 

the excluded person complied with, or 

had made satisfactory arrangements to 

fulfill, all of the applicable conditions of 

participation or conditions of coverage 

under the Medicare statutes and 

regulations; and (5) whether the 

excluded person had, during the period 

of exclusion, submitted claims, or 

caused claims to be submitted or 

payment to be made by Medicare, 

Medicaid, and, where applicable, any 

other Federal health care program, for 

items or services furnished, ordered, or 

prescribed, and the conditions under 

which these actions occurred. 

CMS proposes that reinstatement 

would not be effective until the 

initiating agency granted the request 

and provided notice under § 402.304. 

Reinstatement would be effective as 

provided in the notice. 

A determination for a denial of 

reinstatement would not be appealable 

or reviewable except as provided in 

§ 402.306. 

We also discuss that an ALJ cannot 

require reinstatement of an excluded 

person according to this chapter. The 

content of this section is based on the 

criteria provided by the OIG in 

§ 1001.3002. 

• Section 402.304, Approval of 

request for reinstatement.

[If you choose to comment on issues 

in this section, please include the 

caption ‘‘Approval of request’’ at the 

beginning of your comments.] 

In regard to approval of a request for 

reinstatement (§ 402.304), we discuss 

that, if the initiating agency would grant 

a request for reinstatement, the 

initiating agency would—

(1) Give written notice to the 

excluded person specifying the date of 

reinstatement; and 

(2) Notify appropriate Federal and 

State agencies, and, to the extent 

possible, all others that were originally 

notified of the exclusion, that the person 

had been reinstated into the Medicare 

program. 

A determination by the initiating 

agency to reinstate an excluded person 

would have no effect if Medicare, 

Medicaid, or, where applicable, any 

other Federal health care program had 

imposed a longer period of exclusion 

under its own authorities. The content 

of this section is based on the 

procedures provided by the OIG in 

§ 1001.3003. 

• Section 402.306, Denial of request 

for reinstatement.

[If you choose to comment on issues 

in this section, please include the 

caption ‘‘Denial of request’’ at the 

beginning of your comments.] 

In § 402.306, Denial of request for 

reinstatement, we discuss that, if a 

request for reinstatement is denied, the 

initiating agency would provide written 

notice to the excluded person. Within 

30 days of the date of this notice, the 

excluded person could submit to the 

initiating agency—

(1) Documentary evidence and a 

written argument challenging the 

reinstatement denial; or 

(2) A written request to present 

written evidence and/or oral argument 

to an official of the initiating agency. 

If this written request were received 

timely by the initiating agency, the 

initiating agency, within 15 days of 

receipt of the excluded person’s request, 

would initiate communication with the 

excluded person to establish a time and 

place for the requested meeting. 

In addition, we discuss that, after 

evaluating any additional evidence 

submitted by the excluded person (or at 

the end of the 30-day period described 

above, if no documentary evidence or 

written request were submitted), the 

initiating agency would send written 

notice to the excluded person either 

confirming the denial, or approving the 

reinstatement as set forth in § 402.304. 

If the initiating agency would elect to 

uphold its denial decision, the written 

notice would also indicate that a 

subsequent request for reinstatement 

would not be considered until at least 

1 year after the date of the written 

denial notice. 

The decision to deny reinstatement 

would not be subject to administrative 

review. The content of this section is 

based on the procedures provided by 

the OIG in § 1001.3004. 

III. Collection of Information 

Requirements

While this regulation contains 

information collection requirements, 

these requirements are exempt from the 

Paperwork Reduction Act as stipulated 

in 5 CFR 1320.4(a)(2) (collection of 

information to conduct a civil or 

administrative action, investigation, or 

audit involving an agency against 

specific individuals or entities). 

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 

[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 impacts of this 

proposed 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), 

Executive Order 13132 (August 4, 1999, 

Federalism), and the Unfunded 

Mandates Reform Act of 1995 (2 U.S.C. 

1532). 

Executive Order 12866 directs 

agencies taking ‘‘significant regulatory 

action’’ to reflect consideration of all 

43960 Federal Register / Vol. 69, No. 141 / Friday, July 23, 2004 / Proposed Rules 

costs and benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). A regulatory impact analysis 

(RIA) must be prepared for major rules 

with economically significant effects 

($100 million or more annually). This 

proposed rule is not a significant 

regulatory action as defined by section 

3(f) of Executive Order 12866. We 

believe that there are no significant 

costs associated with this proposed rule 

that would impose any mandates on 

State, local or tribal governments, or the 

private sector that would result in an 

expenditure of $100 million in any 

given year. We expect that all program 

participants would comply with the 

statutory and regulatory requirements 

making unnecessary the imposition of 

an exclusion from Medicare, Medicaid 

and, where applicable, other Federal 

health care programs. Therefore, we do 

not anticipate more than a de minimis

economic impact as a result of this 

proposed rule. Further, any impact that 

may occur would only affect those 

limited few individuals or entities that 

engage in prohibited behavior. We do 

not anticipate any savings or costs as a 

result of this proposed rule. 

The RFA (15 U.S.C. 603(a)), as 

modified by the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (SBREFA), requires agencies to 

determine whether the proposed rule 

would have a significant economic 

impact on a substantial number of small 

entities and, if so, to identify in the 

notice of proposed rulemaking any 

regulatory options that could mitigate 

the impact of the proposed regulation 

on small businesses. For purposes of the 

RFA, small entities include small 

businesses, nonprofit organizations and 

small government jurisdictions. Most 

hospitals and most other providers and 

suppliers are small entities, either by 

nonprofit status or by having revenues 

of $26 million or less annually. 

Individuals and States are not included 

in the definition of a small entity. We 

believe that any impact as a result of the 

proposed rule would be minimal, since, 

as mentioned above, the only 

individuals or entities affected would be 

those limited few who engage in 

prohibited conduct. Since the vast 

majority of program participants comply 

with statutory and regulatory 

requirements, any aggregate economic 

impact would not be significant. 

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 100 beds. We do not believe 

a regulatory impact analysis is required 

here because, for the reasons stated 

above concerning our obligations under 

the RFA and the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (SBREFA) (Pub. L. 104–121), this 

proposed rule would 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 $110 million. We 

believe that there are no significant 

costs associated with this technical rule 

that would impose any mandates on 

State, local, or tribal governments, or the 

private sector that would result in an 

expenditure of $110 million in any 

given year. As was previously 

mentioned, since the majority of 

program participants comply with 

statutory and regulatory requirements, 

any aggregate economic impact would 

not be significant. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it publishes 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. We have 

determined that this proposed rule 

would not significantly affect the rights, 

roles, or responsibilities of the States. 

This rule would not impose substantial 

direct requirement costs on State or 

local governments, preempt State law, 

or otherwise implicate Federalism. 

In accordance with the provisions of 

Executive Order 12866, this regulation 

was reviewed by the Office of 

Management and Budget.

List of Subjects in 42 CFR Part 402

Administrative practice and 

procedure, Health facilities, Health 

professions, Medicaid, Medicare, 

Penalties.

For the reasons stated in the 

preamble, the Centers for Medicare & 

Medicaid Services proposes to amend 

42 CFR chapter IV, part 402 as set forth 

below:

PART 402—CIVIL MONEY PENALTIES, 

ASSESSMENTS, AND EXCLUSIONS 

1. The authority citation for part 402 

continues to read as follows:

Authority: Secs. 1102 and 1871 of the 

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

1395hh).

Subpart A—General Provisions 

2. In § 402.3, the introductory text is 

republished and a new definition for 

‘‘initiating agency’’ is added in 

alphabetical order to read as follows:

§ 402.3 Definitions. 

For purposes of this part:

* * * * *

Initiating agency means whichever 

agency (CMS or the OIG) initiates the 

interaction with the person.

* * * * *

3. In part 402, a new subpart C is 

added to read as follows:

Subpart C—Exclusions 

Sec. 

402.200 Basis and purpose. 

402.205 Length of exclusion. 

402.208 Factors considered in determining 

whether to exclude, and the length of 

exclusion. 

402.209 Scope and effect of exclusion. 

402.210 Notice of exclusion. 

402.212 Response to notice of proposed 

exclusion. 

402.214 Appeal of exclusion. 

402.300 Request for reinstatement. 

402.302 Basis for reinstatement. 

402.304 Approval of request for 

reinstatement. 

402.306 Denial of request for reinstatement.

Subpart C—Exclusions

§ 402.200 Basis and purpose. 

(a) Basis. This subpart is based on the 

sections of the Act that are specified in 

§ 402.1(e). 

(b) Purpose. This subpart—

(1) Provides for the imposition of an 

exclusion from the Medicare and 

Medicaid programs (and, where 

applicable, other Federal health care 

programs) against persons that violate 

the provisions of the Act provided in 

§ 402.1(e) (and further described in 

§ 402.1(c)); and

(2) Sets forth the appeal rights of 

persons subject to exclusion and the 

procedures for reinstatement following 

exclusion.

§ 402.205 Length of exclusion. 

The length of exclusion from 

participation in Medicare, Medicaid, 

and, where applicable, other Federal 

health care programs is contingent on 

the specific violation of the Medicare 

statute. A full description of the specific 

violations identified in the sections of

Federal Register / Vol. 69, No. 141 / Friday, July 23, 2004 / Proposed Rules 43961

the Act are cross-referenced in the 

regulatory sections listed in the table 

below. 

(a) In no event will the period of 

exclusion exceed 5 years for violation of 

the following sections of the Act:

Social Security Act 

paragraph 

Code of Federal Regulations section 

1833(h)(5)(D) in repeated cases.§ 402.1(c)(1) 

1833(q)(2)(B) in repeated cases.§ 402.1(c)(3) 

1834(a)(11)(A) ........... § 402.1(c)(4) 

1834(a)(18)(B) ........... § 402.1(c)(5) 

1834(b)(5)(C) ............ § 402.1(c)(6) 

1834(c)(4)(C) ............. § 402.1(c)(7) 

1834(h)(3) ................. § 402.1(c)(8) 

1834(j)(4) ................... § 402.1(c)(10) 

1834(k)(6) .................. § 402.1(c)(31) 

1834(l)(6) ................... § 402.1(c)(32) 

1842(b)(18)(B) ........... § 402.1(c)(11) 

1842(k) ...................... § 402.1(c)(12) 

1842(l)(3) ................... § 402.1(c)(13) 

1842(m)(3) ................ § 402.1(c)(14) 

1842(n)(3) ................. § 402.1(c)(15) 

1842(p)(3)(B) in repeated cases.§ 402.1(c)(16) 

1848(g)(1)(B) in repeated cases.§ 402.1(c)(17) 

1848(g)(3)(B) ............. § 402.1(c)(18) 

1848(g)(4)(B)(ii) in repeated cases.§ 402.1(c)(19) 

1879(h) ...................... § 402.1(c)(23) 

(b) For violation of the following 

sections, there is no maximum time 

limit for the period of exclusion.

Social Security Act 

paragraph 

Code of Federal Regulations section 

1834(a)(17)(c) for a 

pattern of contacts.

§ 402.1(e)(2)(i) 

1834(h)(3) for a pattern of contacts.§ 402.1(e)(2)(ii) 

1877(g)(5) ................. § 402.1(c)(22) 

1882(a)(2) ................. § 402.1(c)(24) 

1882(p)(8) ................. § 402.1(c)(25) 

1882(p)(9)(C) ............ § 402.1(c)(26) 

1882(q)(5)(C) ............ § 402.1(c)(27) 

1882(r)(6)(A) ............. § 402.1(c)(28) 

1882(s)(4) .................. § 402.1(c)(29) 

1882(t)(2) .................. § 402.1(c)(30) 

(c) For a person excluded under any 

of the grounds specified in paragraph (a) 

of this section, notwithstanding any 

other requirements in this section, 

reinstatement occurs—

(1) At the expiration of the period of 

exclusion, if the exclusion was imposed 

for a period of 5 years; or

(2) At the expiration of 5 years from 

the effective date of the exclusion, if the 

exclusion was imposed for a period of 

less than 5 years and the initiating 

agency did not receive the appropriate 

written request for reinstatement as 

specified in § 402.300.

§ 402.208 Factors considered in 

determining whether to exclude, and the 

length of exclusion. 

(a) General factors. In determining 

whether to exclude a person and the 

length of exclusion, the initiating 

agency considers the following: 

(1) The nature of the claims and the 

circumstances under which they were 

presented. 

(2) The degree of culpability, the 

history of prior offenses, and the 

financial condition of the person 

presenting the claims. 

(3) The total number of acts in which 

the violation occurred. 

(4) The dollar amount at issue 

(Medicare Trust Fund dollars and/or 

beneficiary out-of-pocket expenses). 

(5) The prior history of the person 

insofar as its willingness or refusal to 

comply with requests to correct said 

violations. 

(6) Any other facts bearing on the 

nature and seriousness of the person’s 

misconduct. 

(7) Any other matters that justice may 

require. 

(b) Criteria to be considered. As a 

guideline for taking into account the 

general factors listed in paragraph (a) of 

this section, the initiating agency may 

consider any one or more of the 

circumstances listed in paragraphs (b)(1) 

and (b)(2) of this section, as applicable. 

The respondent, in his or her written 

response to the notice of intent to 

exclude (that is, the proposed 

exclusion), may provide information 

concerning potential mitigating 

circumstances: 

(1) Aggravating circumstances. An 

aggravating circumstance may be any of 

the following: 

(i) The services or incidents were of 

several types and occurred over an 

extended period of time. 

(ii) There were numerous services or 

incidents, or the nature and 

circumstances indicate a pattern of 

claims or requests for payment or a 

pattern of incidents, or whether a 

specific segment of the population was 

targeted. 

(iii) Whether the person was held 

liable for criminal, civil, or 

administrative sanctions in connection 

with a program covered by this part or 

any other public or private program of 

payment for health care items or 

services at any time before the incident 

or whether the person presented any 

claim or made any request for payment 

that included an item or service subject 

to a determination under § 402.1. 

(iv) There is proof that the person 

engaged in wrongful conduct, other than 

the specific conduct upon which 

liability is based, relating to government 

programs and in connection with the 

delivery of a health care item or service. 

The statute of limitations governing 

civil money penalty proceedings at 

section 1128A(c)(1) of the Act, does not 

apply to proof of other wrongful 

conducts as an aggravating 

circumstance. 

(v) The wrongful conduct had an 

adverse impact on the financial integrity 

of the Medicare program or its 

beneficiaries. 

(vi) The person was the subject of an 

adverse action by any other Federal, 

State, or local government agency or 

board, and the adverse action is based 

on the same set of circumstances that 

serves as a basis for the imposition of 

the exclusion. 

(vii) The noncompliance resulted in a 

financial loss to the Medicare program 

of at least $5,000. 

(viii) The number of instances for 

which full, accurate, and complete 

disclosure was not made as required, or 

provided as requested, and the 

significance of the undisclosed 

information. 

(2) Mitigating circumstances. A 

mitigating circumstance may be any of 

the following: 

(i) All incidents of noncompliance 

were few in nature and of the same type, 

occurred within a short period of time, 

and the total amount claimed or 

requested for the items or services 

provided was less than $1,500. 

(ii) The claim(s) or request(s) for 

payment for the item(s) or service(s) 

provided by the person were the result 

of an unintentional and unrecognized 

error in the person’s process for 

presenting claims or requesting 

payment, and the person took corrective 

steps promptly after the error was 

discovered. 

(iii) Previous cooperation with a law 

enforcement or regulatory entity 

resulted in convictions, exclusions, 

investigations, reports for weaknesses, 

or civil money penalties against other 

persons. 

(iv) Alternative sources of the type of 

health care items or services furnished 

by the person are not available to the 

Medicare population in the person’s 

immediate area.

(v) The person took corrective action 

promptly upon learning of the 

noncompliance from the person’s 

employee or contractor, or by the 

Medicare contractor. 

(vi) The person had a documented 

mental, emotional, or physical 

condition before or during the 

commission of the noncompliant act(s) 

and that condition reduces the person’s 

culpability for the acts in question. 

43962 Federal Register / Vol. 69, No. 141 / Friday, July 23, 2004 / Proposed Rules 

(vii) The completeness and timeliness 

of refunding to the Medicare Trust Fund 

or Medicare beneficiaries any 

inappropriate payments. 

(viii) The degree of culpability of the 

person in failing to provide timely and 

complete refunds. 

(3) Other matters as justice may 

require. Other circumstances of an 

aggravating or mitigating nature are 

taken into account if, in the interest of 

justice, those circumstances require 

either a reduction or increase in the 

sanction in order to ensure achievement 

for the purposes of this subpart. 

(c) Limitations. (1) The standards set 

forth in this section are binding on the 

person, except to the extent that their 

application results in an imposition of 

an amount that exceeds the limits 

imposed by the United States 

Constitution. 

(2) Nothing in this section limits the 

authority of the initiating agency to 

settle any issue or case as provided by 

§ 402.17, or to compromise any penalty 

and assessment as provided by 

§ 402.115.

§ 402.209 Scope and effect of exclusion. 

(a) Scope of exclusion. Under this 

title, persons may be excluded from the 

Medicare, Medicaid, and, where 

applicable, any other Federal health 

care programs. 

(b) Effect of exclusion on a person(s).

(1) Unless and until an excluded person 

is reinstated into the Medicare program, 

no payment is made by Medicare, 

Medicaid, and, where applicable, any 

other Federal health care programs for 

any item or service furnished by the 

excluded person or at the direction or 

request of the excluded person when the 

person furnishing the item or service 

knew or had reason to know of the 

exclusion, on or after the effective date 

of the exclusion as specified in the 

notice of exclusion. 

(2) An excluded person may not take 

assignment of a Medicare beneficiary’s 

claim on or after the effective date of the 

exclusion. 

(3) An excluded person that submits, 

or causes to be submitted, claims for 

items or services furnished during the 

exclusion period is subject to civil 

money penalty liability under section 

1128A(a)(1)(D) of the Act, and criminal 

liability under section 1128B(a)(3) of the 

Act. In addition, submission of claims, 

or the causing of claims to be submitted 

for items or services furnished, ordered, 

or prescribed, by an excluded person 

may serve as the basis for denying 

reinstatement to the Medicare program. 

(c) Exceptions to paragraph (b)(1) of 

this section. (1) If a Medicare beneficiary 

or other person (including a supplier) 

submits an otherwise payable claim for 

items or services furnished by an 

excluded person, or under the medical 

direction or on the request of an 

excluded person after the effective date 

of the exclusion, CMS pays the first 

claim submitted by the beneficiary or 

other person and immediately notify the 

claimant of the exclusion. CMS does not 

pay a beneficiary or other person 

(including a supplier) for items or 

services furnished by, or under the 

medical direction of, an excluded 

person, more than 15 days after the date 

on the notice to the beneficiary or other 

person (including a supplier), or after 

the effective date of the exclusion, 

whichever is later. 

(2) Notwithstanding the other 

provisions of this section, payment may 

be made for certain emergency items or 

services furnished by an excluded 

person, or under the medical direction 

or on the request of an excluded person 

during the period of exclusion. To be 

payable, a claim for the emergency 

items or services must be accompanied 

by a sworn statement of the person 

furnishing the items or services, 

specifying the nature of the emergency 

and the reason that the items or services 

were not furnished by a person eligible 

to furnish or order the items or services. 

No claim for emergency items or 

services is payable if those items or 

services were provided by an excluded 

person that, through employment, 

contractual, or under any other 

arrangement, routinely provides 

emergency health care items or services.

§ 402.210 Notice of exclusion. 

(a) Notice of proposed determination.

When the initiating agency proposes to 

exclude a person from participation in 

a Federal health care program in 

accordance with this part, notice of the 

intent to exclude must be given in 

writing, and delivered or sent by 

certified mail, return receipt requested. 

The written notice must include, at a 

minimum, the following: 

(1) Reference to the statutory basis for 

the exclusion. 

(2) A description of the claims, 

requests for payment, or incidents for 

which the exclusion is proposed.

(3) The reason why those claims, 

requests for payments, or incidents 

subject the person to an exclusion. 

(4) The length of the proposed 

exclusion. 

(5) A description of the circumstances 

that were considered when determining 

the period of exclusion. 

(6) Instructions for responding to the 

notice, including a specific statement of 

the person’s right to submit 

documentary evidence and a written 

response concerning whether the 

exclusion is warranted, and any related 

issues such as potential mitigating 

circumstances. The notice must specify 

that—

(i) The person has the right to request 

an opportunity to present oral argument 

to an official of the initiating agency. 

(ii) The request for oral argument 

must be submitted within 30 days of the 

receipt of the notice of intent to exclude. 

(7) If a person fails, within the time 

permitted under § 402.212, to exercise 

the right to respond to the notice of 

intent to exclude, the initiating agency 

may initiate actions for the imposition 

of the exclusion. 

(b) Notice of exclusion. Once the 

initiating agency determines that an 

exclusion is warranted, a written notice 

of exclusion is sent to the person in the 

same manner as described in paragraph 

(a) of this section. The exclusion is 

effective 20 days from the date of the 

notice. The written notice must include, 

at a minimum, the following: 

(1) The basis for the exclusion. 

(2) The length of the exclusion and, 

when applicable, the factors considered 

in setting the length. 

(3) The effect of exclusion. 

(4) The earliest date on which the 

initiating agency considers a request for 

reinstatement. 

(5) The requirements and procedures 

for reinstatement. 

(6) The appeal rights available to the 

excluded person under part 1005 of this 

title. 

(c) Amendment to the notice. No later 

than 15 days before the final exhibit 

exchanges required under § 1005.8 of 

this title, the initiating agency may 

amend the notice of exclusion if 

information becomes available that 

justifies the imposition of a period of 

exclusion other than the one proposed 

in the original written notice.

§ 402.212 Response to notice of proposed 

exclusion. 

(a) A person that receives a notice of 

intent to exclude (that is, the proposed 

determination) as described in 

§ 402.210, may present to the initiating 

agency a written response arguing 

whether the proposed exclusion is 

warranted, and may present additional 

supportive documentation. The person 

must submit this response within 60 

days of the receipt of notice. The 

initiating agency reviews the materials 

presented and initiate a response to the 

person regarding the argument 

presented, and any changes to the 

determination, if appropriate. 

(b) The person is also afforded an 

opportunity to be heard by the initiating 

agency in order to present oral argument 

Federal Register / Vol. 69, No. 141 / Friday, July 23, 2004 / Proposed Rules 43963

concerning whether the proposed 

exclusion is warranted and any related 

matters. The person must submit this 

request within 60 days of the receipt of 

notice. Within 15 days of receipt of the 

person’s request, the initiating agency 

initiates communication with the 

person to establish a mutually agreed 

upon time and place for the requested 

hearing.

§ 402.214 Appeal of exclusion. 

(a) The procedures in part 1005 of this 

title apply to all appeals of exclusions. 

References to the Inspector General in 

that part apply to the initiating agency. 

(b) A person excluded under this 

subpart may file a request for a hearing 

before an administrative law judge (ALJ) 

only on the issues of whether—

(1) The basis for the imposition of the 

exclusion exists; and 

(2) The duration of the exclusion is 

unreasonable. 

(c) When the initiating agency 

imposes an exclusion for a period of 1 

year or less, paragraph (b)(2) of this 

section does not apply. 

(d) The excluded person must file a 

request for a hearing within 60 days 

from the receipt of notice of exclusion. 

The effective date of an exclusion is not 

delayed beyond the date stated in the 

notice of exclusion simply because a 

request for a hearing is timely filed (see 

paragraph (g) of this section). 

(e) A timely filed written request for 

a hearing must include—

(1) A statement as to the specific 

issues or findings of fact and 

conclusions of law in the notice of 

exclusion with which the person 

disagrees. 

(2) Basis for the disagreement. 

(3) The general basis for the defenses 

that the person intends to assert. 

(4) Reasons why the proposed length 

of exclusion should be modified. 

(5) Reasons, if applicable, why the 

health or safety of Medicare 

beneficiaries receiving items or services 

does not warrant the exclusion going 

into or remaining in effect before the 

completion of an ALJ proceeding in 

accordance with part 1005 of this title. 

(f) If the excluded person does not file 

a written request for a hearing as 

provided in paragraph (d) of this 

section, the initiating agency notifies the 

excluded person, by certified mail, 

return receipt requested, that the 

exclusion goes into effect or continues 

in accordance with the notice of 

exclusion. The excluded person has no 

right to appeal the exclusion other than 

as described in this section. 

(g) If the excluded person files a 

written request for a hearing, and asserts 

in the request that the health or safety 

of Medicare beneficiaries does not 

warrant the exclusion going into or 

remaining in effect before completion of 

an ALJ hearing, then the initiating 

agency may make a determination as to 

whether the exclusion goes into effect or 

continues pending the outcome of the 

ALJ hearing.

§ 402.300 Request for reinstatement. 

(a) An excluded person may submit a 

written request for reinstatement to the 

initiating agency no sooner than 120 

days prior to the terminal date of 

exclusion as specified in the notice of 

exclusion. The written request for 

reinstatement must include 

documentation demonstrating that the 

person has met the standards set forth 

in § 402.302. Obtaining or reactivating a 

Medicare provider number (or 

equivalent) does not constitute 

reinstatement. 

(b) Upon receipt of a written request 

for reinstatement, the initiating agency 

may require the person to furnish 

additional, specific information, and 

authorization to obtain information from 

private health insurers, peer review 

organizations, and others as necessary to 

determine whether reinstatement is 

granted. 

(c) Failure to submit a written request 

for reinstatement and/or to furnish the 

required information or authorization 

results in the continuation of the 

exclusion, unless the exclusion has been 

in effect for 5 years. In this case, 

reinstatement is automatic. 

(d) If a period of exclusion is reduced 

on appeal (regardless of whether further 

appeal is pending), the excluded person 

may request and apply for reinstatement 

within 120 days of the expiration of the 

reduced exclusion period. A written 

request for the reinstatement includes 

the same standards as noted in 

paragraph (b) of this section.

§ 402.302 Basis for reinstatement. 

(a) The initiating agency authorizes 

reinstatement if it determines that—

(1) The period of exclusion has 

expired; 

(2) There are reasonable assurances 

that the types of actions that formed the 

basis for the original exclusion did not 

recur and will not recur; and 

(3) There is no additional basis under 

title XVIII of the Act that justifies the 

continuation of the exclusion. 

(b) The initiating agency does not 

authorize reinstatement if it determines 

that submitting claims or causing claims 

to be submitted or payments to be made 

by the Medicare program for items or 

services furnished, ordered, or 

prescribed, may serve as a basis for 

denying reinstatement. This section 

applies regardless of whether the 

excluded person has obtained a 

Medicare provider number (or 

equivalent), either as an individual or as 

a member of a group, before being 

reinstated. 

(c) In making a determination 

regarding reinstatement, the initiating 

agency considers the following—

(1) Conduct of the excluded person 

occurring before the date of the notice 

of the exclusion, if that conduct was not 

known to the initiating agency at the 

time of the exclusion; 

(2) Conduct of the excluded person 

after the date of the exclusion; 

(3) Whether all fines and all debts due 

and owing (including overpayments) to 

any Federal, State, or local government 

that relate to Medicare, Medicaid, or, 

where applicable, any Federal, State, or 

local health care program are paid in 

full, or satisfactory arrangements are 

made to fulfill these obligations; 

(4) Whether the excluded person 

complies with, or has made satisfactory 

arrangements to fulfill, all of the 

applicable conditions of participation or 

conditions of coverage under the 

Medicare statutes and regulations; and 

(5) Whether the excluded person has, 

during the period of exclusion, 

submitted claims, or caused claims to be 

submitted or payment to be made by 

Medicare, Medicaid, and, where 

applicable, any other Federal health 

care program, for items or services 

furnished, ordered, or prescribed, and 

the conditions under which these 

actions occurred. 

(d) Reinstatement is not effective until 

the initiating agency grants the request 

and provide notices under § 402.304. 

Reinstatement is effective as provided in 

the notice. 

(e) A determination for a denial of 

reinstatement is not appealable or 

reviewable except as provided in 

§ 402.306. 

(f) An ALJ may not require 

reinstatement of an excluded person in 

accordance with this chapter.

§ 402.304 Approval of request for 

reinstatement. 

(a) If the initiating agency grants a 

request for reinstatement, the initiating 

agency—

(1) Gives written notice to the 

excluded person specifying the date of 

reinstatement; and 

(2) Notifies appropriate Federal and 

State agencies, and, to the extent 

possible, all others that were originally 

notified of the exclusion, that the person 

is reinstated into the Medicare program. 

(b) A determination by the initiating 

agency to reinstate an excluded person 

has no effect if Medicare, Medicaid, or, 

43964 Federal Register / Vol. 69, No. 141 / Friday, July 23, 2004 / Proposed Rules 

where applicable, any other Federal 

health care program has imposed a 

longer period of exclusion under its 

own authorities.

§ 402.306 Denial of request for 

reinstatement. 

(a) If a request for reinstatement is 

denied, the initiating agency provides 

written notice to the excluded person. 

Within 30 days of the date of this notice, 

the excluded person may submit to the 

initiating agency—

(1) Documentary evidence and a 

written argument challenging the 

reinstatement denial; or 

(2) A written request to present 

written evidence and/or oral argument 

to an official of the initiating agency. 

(b) If a written request as described in 

paragraph (a)(2) of this section is 

received timely by the initiating agency, 

the initiating agency, within 15 days of 

receipt of the excluded person’s request, 

initiates communication with the 

excluded person to establish a time and 

place for the requested meeting. 

(c) After evaluating any additional 

evidence submitted by the excluded 

person (or at the end of the 30-day 

period described in paragraph (a) of this 

section, if no documentary evidence or 

written request is submitted), the 

initiating agency sends written notice to 

the excluded person either confirming 

the denial, or approving the 

reinstatement in the manner set forth in 

§ 402.304. If the initiating agency elects 

to uphold its denial decision, the 

written notice also indicates that a 

subsequent request for reinstatement 

will not be considered until at least 1 

year after the date of the written denial 

notice. 

(d) The decision to deny 

reinstatement is not subject to 

administrative review.

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program)

Dated: September 5, 2003. 

Thomas A. Scully, 

Administrator, Centers for Medicare and 

Medicaid Services.

Dated: March 15, 2004. 

Tommy G. Thompson, 

Secretary.

[FR Doc. 04–16791 Filed 7–22–04; 8:45 am] 

BILLING CODE 4120–01–U

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service 

50 CFR Part 32

RIN 1018–AT40

2004–2005 Refuge-Specific Hunting 

and Sport Fishing Regulations; 

Correction

AGENCY: Fish and Wildlife Service, 

Interior.

ACTION: Correction to proposed 

regulations. 

SUMMARY: This document contains 

corrections to the proposed regulations 

which were published June 30, 2004, 

(69 FR 39552). The proposed regulations 

related to the addition of 10 refuges and 

wetland management districts to the list 

of areas open for hunting and/or sport 

fishing programs and increase the 

activities available at 7 other refuges. 

We also develop pertinent refugespecific regulations for those activities 

and amend certain regulations on other 

refuges that pertain to migratory game 

bird hunting, upland game hunting, big 

game hunting, and sport fishing for the 

2004–2005 season.

DATES: We must receive your comments 

on or before July 30, 2004.

FOR FURTHER INFORMATION CONTACT:

Leslie Marler, (703) 358–2397.

SUPPLEMENTARY INFORMATION: 

Background 

We issue refuge-specific regulations 

when we open wildlife refuges to 

migratory game bird hunting, upland 

game hunting, big game hunting, or 

sport fishing. These regulations list the 

wildlife species that you may hunt or 

fish, season, bag or creel limits, methods 

of hunting or sport fishing, descriptions 

of areas open to hunting or sport fishing, 

and other provisions as appropriate. The 

regulations that are the subject of these 

corrections increase opportunity to hunt 

upland game only at Big Oaks National 

Wildlife Refuge in the State of Indiana. 

Need for Correction 

We provided information in the 

SUPPLEMENTARY INFORMATION section 

indicating that Big Oaks National 

Wildlife Refuge was opening for the first 

time to migratory bird and upland game. 

The refuge is not opening to migratory 

bird hunting. The ‘‘X’’ will be removed 

from the chart in the SUPPLEMENTARY

INFORMATION on page 39553 under 

migratory bird hunting, and the 

amendatory text under § 32.33 for that 

refuge should continue to reflect that 

migratory bird hunting is reserved and 

that we are opening to upland game 

hunting. 

Correction of Publication 

Accordingly, the publication on June 

30, 2004, of the proposed regulations is 

corrected as follows:

PART 32—[CORRECTED]

§ 32.33 [Corrected] 

1. Direction #15 on page 39595 in the 

third column is corrected by adding 

instruction c. as follows: c. Revising 

paragraph B. of ‘‘Big Oaks National 

Wildlife Refuge.’’

2. The listing for Big Oaks National 

Wildlife Refuge should be inserted on 

page 39595 in the third column in 

§ 32.33 before the listing for 

‘‘Muscatatuck National Wildlife 

Refuge’’. The listing reads as follows: 

Big Oaks National Wildlife Refuge 

***

B. Upland Game Hunting. We allow 

hunting of squirrel in accordance with 

State regulations subject to the 

following condition: We require a refuge 

permit.

* * * * *

Dated: July 19, 2004. 

Susan Wilkinson, 

Fish and Wildlife Service, Federal Register 

Liaison.

[FR Doc. 04–16763 Filed 7–22–04; 8:45 am] 

BILLING CODE 4310–55–P