Federal Register / Vol. 70, No. 149 / Thursday, August 4, 2005 / Proposed Rules 44879

developing the Copyright Office’s 

system for online preregistration, it is 

not entirely clear whether the system 

will be compatible with web browsers 

other than Microsoft Internet Explorer 

versions 5.1 and higher. Filers of 

preregistration applications will be able 

to employ these Internet Explorer 

browsers successfully. Support for 

Netscape 7.2, Firefox 1.0.3, and Mozilla 

1.7.7 is planned but will not be 

available when preregistration goes into 

effect. Present users of these browsers 

may experience problems when filing 

claims.

In order to ensure that preregistration 

can be implemented in a smoothly 

functioning and timely manner, the 

Office now seeks comments that will 

assist it in determining whether any 

eligible parties will be prevented from 

preregistering a claim due to browser 

requirements of the preregistration 

system. Therefore, this notice seeks 

information whether any potential 

preregistration filers would have 

difficulties using Internet Explorer 

(version 5.1 or higher) to file 

preregistration claims, and if so, why. 

More generally, in the interest of 

achieving support for browsers in the 

Office’s preregistration processing 

environment, this notice inquires 

whether (and why) an eligible party 

who anticipates preregistering a claim 

on the electronic–only form will not be 

able to use Internet Explorer to do so, 

or will choose not to preregister if it is 

necessary to use Internet Explorer.

The Office requests that responses to 

this supplemental notice of inquiry be 

made part of the responders’ comments 

on the July 22nd Notice of Proposed 

Rulemaking. Whether or not 

accompanied by comments on the 

proposed rule, the response to this 

notice of inquiry should be submitted 

by the due dates for comment on the 

Notice of Proposed Rulemaking, i.e., no 

later than August 22, 2005, with reply 

comments due no later than September 

7, 2005.

Dated: August 1, 2005.

Tanya Sandros,

Associate General Counsel.

[FR Doc. 05–15458 Filed 8–3–05; 8:45 am]

BILLING CODE 1410–30–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 402 

[CMS–6019–P] 

RIN 0938–AN48 

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 sets forth 

the general requirements and 

procedures that would allow certain 

entities who are identified for exclusion 

from the Medicare program to request 

that CMS act on their behalf to 

recommend to the Inspector General 

that their exclusion from Medicare be 

waived because of a hardship that 

would result on Medicare beneficiaries. 

This proposed rule would implement 

section 949 of the Medicare Prescription 

Drug, Improvement, and Modernization 

Act of 2003 (MMA).

DATES: To be assured consideration, 

comments must be received at the 

appropriate address, as provided below, 

no later than 5 p.m. on October 3, 2005.

ADDRESSES: In commenting, please refer 

to file code CMS–6019–P. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

three ways (no duplicates, please): 

1. Electronically. You may submit 

electronic comments on specific issues 

in this regulation to http://

www.cms.hhs.gov/regulations/

ecomments. (Attachments should be in 

Microsoft Word, WordPerfect, or Excel; 

however, we prefer Microsoft Word.) 

2. By 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–6019–P, P.O. 

Box 8010, Baltimore, MD 21244–8010. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. 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–

9994 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 stamp in and 

retaining an extra copy of the comments 

being filed. 

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–6019–P 

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. CMS posts all electronic 

comments received before the close of 

the comment period on its public 

website as soon as possible after they 

have been received. Hardcopy 

comments received timely will 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.

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.gpoaccess.gov/fr/index.html. 

44880 Federal Register / Vol. 70, No. 149 / Thursday, August 4, 2005 / Proposed Rules 

I. Background

[If you choose to comment on issues in this 

section, please include the caption 

‘‘BACKGROUND’’ at the beginning of your 

comments.]

Section 1128A of the Social Security 

Act (the Act) authorizes the Secretary of 

Health and Human Services to impose 

civil money penalties (CMPs), 

assessments, and/or exclusion from the 

Medicare program for certain health 

care facilities, practitioners, suppliers or 

other entities under prescribed 

circumstances. Exclusion, as defined in 

42 CFR 402.3, 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. 

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 

the Inspector General (OIG) or the 

Centers for Medicare & Medicaid 

Services (CMS). The exclusion 

authorities delegated to the OIG address 

fraud, misrepresentation, or 

falsification, while those delegated to us 

address noncompliance with 

programmatic or regulatory 

requirements. However, the OIG has the 

authority to impose an exclusion and to 

prosecute cases involving exclusions 

that were delegated to us, 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 (63 FR 68687) delineating 

the procedures for pursuing 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 we did 

reserve subpart C to incorporate this 

information in the future. 

In the December 14, 1998 final rule, 

we indicated that our procedures for 

imposing the CMPs and assessment 

authorities delegated to us were based 

on the procedures that the OIG 

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. 

On July 23, 2004, we published a 

proposed rule in the Federal Register

(69 FR 43956), delineating the 

procedures for pursuing exclusions. It is 

our intent to respond to the public 

comments we received from the July 3, 

2004 proposed rule and this rule in a 

single final rule. 

Section 949 of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA) (Pub. 

L. 108–173) amended section 

1128(c)(3)(B) of the Act to indicate that, 

‘‘Subject to subparagraph (g), in the case 

of an exclusion under subsection (a), the 

minimum period of exclusion shall not 

be less than 5 years, except that, upon 

the request of the administrator of a 

Federal health care program (as defined 

in section 1128B(f)) who determines 

that the exclusion would impose a 

hardship on individuals entitled to 

benefits under Part A of title XVIII or 

enrolled under Part B of such title, or 

both, the Secretary may, after consulting 

with the Inspector General of the 

Department of Health and Human 

Services, waive the exclusion under 

subsection (a)(1), (a)(3), or (a)(4) with 

respect to that program in the case of an 

individual or entity that is the sole 

community physician or sole source of 

essential specialized services in the 

community.’’ The Conference 

Agreement accompanying the MMA 

clarifies the intent of the statutory 

requirement that a hardship 

determination be made before a waiver 

is approved. 

II. Provisions of the Proposed Rule

[If you choose to comment on issues in this 

section, please include the caption 

‘‘PROVISIONS OF THE PROPOSED RULE’’

at the beginning of your comments.]

This proposed rule would amend part 

402, by adding to subpart C, a new 

section that establishes the general 

requirements and procedures 

concerning our authority to request a 

waiver of exclusion, for an excluded 

person, from Medicare exclusions that 

are imposed by the OIG. 

Specifically, we are proposing to add 

the following provision to subpart C: 

• Section 402.308, Waivers of 

Exclusions. 

This section provides the basis and 

purpose for the excluded person to 

make a request to us. This subpart also 

sets forth the requirements that must be 

met by the excluded person in order for 

us to make a request to the OIG of a 

waiver to the exclusion. The statute 

specifies the basis upon which a request 

of waiver for an exclusion must be 

based, but provides few details 

regarding the administrative decisionmaking process. 

We will consider any supportive 

information submitted by the 

respondent. We will not limit nor 

suggest what type of information may be 

presented. However, while the burden 

to present convincing information is left 

to the discretion of the respondent, we 

will initiate our own validation of the 

facts presented. During this analysis, we 

may require the person to furnish 

additional, specific information, and 

authorization to obtain information from 

private health insurers, peer review 

organizations (including, but not limited 

to, Quality Improvement Organizations), 

and others as necessary to determine the 

validity of the facts provided. 

It is our interpretation that unless a 

hardship (defined for purposes of 

§ 402.308 as something that negatively 

affects Medicare beneficiaries and 

results from the imposition of an 

exclusion, because the excluded person 

is the sole community physician or sole 

source of essential specialized services 

in the Medicare community) is met, no 

requests for a waiver of Medicare 

exclusion will be considered or 

forwarded to the OIG by CMS. Our 

decision is not subject to administrative 

or judicial review. Furthermore, a 

request made by CMS to the OIG does 

not automatically grant a waiver. The 

final decision is that of the OIG as 

defined in § 1001.1801 of the OIG’s 

regulations. 

III. Collection of Information 

Requirements 

The collection of information 

requirements at 5 CFR part 1320 are 

applicable to requirements affecting 10 

or more entities. While this proposed 

rule contains information collection 

requirements, because we believe that 

these requirements will affect less than 

10 entities, we believe that these 

collection requirements are exempt from 

OMB for review and approval, as 

specified at 5 CFR 1320.3(c)(4). 

Consequently, this proposed rule need 

not be reviewed by the Office of 

Management and Budget under the 

authority of the Paperwork Reduction 

Act of 1995. 

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 

Federal Register / Vol. 70, No. 149 / Thursday, August 4, 2005 / Proposed Rules 44881

respond to the major comments in the 

preamble to that document.

V. Regulatory Impact Statement 

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 

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 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. Since most program 

participants 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, 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) (Pub. L. 104–121), 

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 have engaged in 

prohibited conduct and were excluded 

from the Medicare program by the OIG. 

Since the vast majority of program 

participants comply with statutory and 

regulatory requirements and are not 

excluded from the Medicare program, 

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 SBREFA, 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 and are not excluded from 

the Medicare program, 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, the Office of 

Management and Budget reviewed this 

regulation.

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 as set forth below:

PART 402—CIVIL MONEY PENALTIES, 

ASSESSMENTS, AND EXCLUSIONS

Subpart C—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).

2. Part 402, subpart C is amended by 

adding § 402.308 to read as follows:

§ 402.308 Waivers of exclusions. 

(a) Basis. Section 1128(c)(3)(B) of the 

Act specifies that in the case of an 

exclusion from participation in the 

Medicare program based upon section 

1128(a)(1), (a)(3), or (a)(4) of the Act, the 

individual may request that CMS 

present, on his or her behalf, a request 

to the OIG for a waiver of the exclusion. 

(b) Definition. For purposes of this 

part: 

(1) Excluded person has the same 

meaning as a ‘‘person’’ as defined in 

§ 402.3 who meets for the purposes of 

this subpart, the definition of the term 

‘‘exclusion’’ in § 402.3. 

(2) Hardship for purposes of this 

section means something that negatively 

affects Medicare beneficiaries and 

results from the imposition of an 

exclusion, because the excluded person 

is the sole community physician or sole 

source of essential specialized services 

in the Medicare community. 

(c) General rule. If CMS determines 

that a hardship as defined in paragraph 

(b)(2) of this section results from 

exclusion of an affected person from the 

Medicare program, CMS may consider 

and may make a recommendation to the 

Inspector General for waiver of the 

Medicare exclusion. 

(d) Submission and content of a 

waiver of exclusion request. An 

excluded person must submit a request 

for waiver of exclusion in writing to 

CMS that includes the following: 

44882 Federal Register / Vol. 70, No. 149 / Thursday, August 4, 2005 / Proposed Rules 

(1) A copy of the exclusion notice 

from the OIG. 

(2) A statement requesting that CMS 

present a waiver of exclusion request to 

the OIG on his or her behalf. 

(3) A statement that he or she is the 

sole community physician or sole 

source of essential specialized services 

in the community. 

(4) Documentation to support the 

statement in paragraph (d)(3) of this 

section. 

(e) Processing of waiver of exclusion 

requests. CMS processes a request for a 

waiver of exclusion as follows: 

(1) Notifies the submitter that the 

waiver of exclusion request has been 

received. 

(2) Reviews and validates all 

submitted documents. 

(3) During its analysis, CMS may 

require additional, specific information, 

and authorization to obtain information 

from private health insurers, peer 

review organizations (including, but not 

limited to, Quality Improvement 

Organizations), and others as necessary 

to determine validity. 

(4) Makes a determination regarding 

whether or not to submit the waiver of 

exclusion request to the OIG based on 

review and validation of the submitted 

documents. 

(5) If CMS elects to submit the waiver 

of exclusion request to the OIG, CMS 

copies the excluded person on the 

request. 

(6) If CMS denies the request, then 

CMS notifies the excluded person of the 

decision and specifies the reason(s) for 

the decision. 

(f) Administrative or judicial review.

A determination rendered under 

paragraph (e)(3) of this section is not 

subject to administrative or judicial 

review.

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program)

Dated: April 8, 2005. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Dated: April 15, 2005. 

Michael O. Leavitt, 

Secretary.

[FR Doc. 05–15291 Filed 8–3–05; 8:45 am] 

BILLING CODE 4120–01–P