[Federal Register Volume 64, Number 140 (Thursday, July 22, 1999)]
[Rules and Regulations]
[Pages 39420-39429]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-18515]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of Inspector General

42 CFR Parts 1001, 1002 and 1003

RIN 0991-AA95


Health Care Programs: Fraud and Abuse; Revised OIG Sanction 
Authorities Resulting From Public Law 105-33

AGENCY: Office of Inspector General (OIG), HHS.

ACTION: Final rule.

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SUMMARY: This rulemaking revises the OIG's exclusion and civil money 
penalty authorities set forth in 42 CFR parts 1001, 1002 and 1003, as a 
result of the Balanced Budget Act of 1997, Public Law 105-33. These 
revisions are intended to protect Medicare and other Federal health 
care programs by enhancing the OIG's administrative sanction authority 
through new or revised exclusion and civil money penalty provisions.

EFFECTIVE DATE: This rule is effective on July 22, 1999.

FOR FURTHER INFORMATION CONTACT: Joel Schaer, (202) 619-0089, OIG 
Regulations Officer.

SUPPLEMENTARY INFORMATION:

I. Background

A. The Health Insurance Portability and Accountability Act

    The Health Insurance Portability and Accountability Act (HIPAA) of 
1996, Public Law 104-191, was enacted on August 21, 1996, and set forth 
a number of significant amendments to the OIG's exclusion and civil 
money penalty (CMP) authorities. Among the various provisions related 
to the program exclusion authority, HIPAA: (1) Expanded the OIG's 
minimum 5-year mandatory exclusion authority to cover any felony 
conviction under Federal, State or local law relating to health care 
fraud, even if governmental programs were not involved; (2) established 
minimum periods of exclusion from 1 to 3 years for certain permissive 
exclusions; and (3) established a new permissive exclusion authority 
applicable to individuals who have a

[[Page 39421]]

majority ownership in, or have significant control over the operations 
of an entity that has been convicted of a program-related offense. 
Proposed regulations addressing these revised or expanded OIG exclusion 
authorities were published in the Federal Register on September 8, 1997 
(62 FR 47182) and final regulations were issued on September 2, 1998 
(63 FR 46676).
    In addition, HIPAA revised and strengthened the OIG's existing CMP 
authorities, and extended the application of the CMP provisions beyond 
those programs funded by the Department to include all Federal health 
care programs. Separate OIG proposed rulemaking addressing the revised 
or expanded CMP provisions resulting from HIPAA were published in the 
Federal Register on March 25, 1998 (63 FR 14393).

B. The Balanced Budget Act of 1997

    In conjunction with many of the HIPAA fraud and abuse authorities, 
the Balanced Budget Act (BBA) of 1997, enacted on August 5, 1997, 
contained a number of provisions designed to further protect the 
integrity of Medicare, Medicaid and all other Federal health care 
programs for current and future beneficiaries, and combat fraudulent 
and abusive program activities. Specifically, the fraud and abuse 
provisions of BBA serve to strengthen the OIG's exclusion and CMP 
authorities with respect to Federal health care programs.
    While the new exclusion and CMP authorities under BBA were 
effective for violations occurring on or after August 5, 1997, since 
the statutory provisions allowed the Department some policy discretion 
in their implementation, the OIG developed and issued a proposed 
rulemaking on September 2, 1998, that solicited public comments on 
proposed exclusion and CMP regulatory revisions resulting from BBA (63 
FR 46736).

II. Summary of the Proposed Rule

    In accordance with the Department's expanded and revised exclusion 
and CMP authorities resulting from BBA, the proposed regulations were 
designed to codify in 42 CFR parts 1001, 1002 and 1003 as follows:

A. Revised Exclusion Authorities Resulting From BBA

    1. OIG authority to direct exclusions from State health care 
programs, and to extend application of OIG exclusions to all Federal 
health care programs--Prior to BBA, the OIG was authorized under 
section 1128 of the Act to impose exclusions from participation in 
Medicare under its own authority, but could not impose other health 
care program exclusions directly. Instead, the OIG directed State 
health care programs (such as Medicaid) to impose parallel exclusions, 
but had no authority with respect to the exclusion from State health 
care programs, as listed in section 1128(i) of the Act. Section 4331(c) 
of BBA specifically amended sections 1128(a) and (b) of the Act to 
extend the scope of an OIG exclusion beyond the Medicare and State 
health care programs to all Federal health care programs (as defined in 
section 1128B(f) of the Act), and to enable the OIG to impose 
exclusions from all Federal health care programs directly. We proposed 
amending various sections of 42 CFR part 1001 to reflect this expanded 
authority.
    The proposed regulations also addressed the effect of this expanded 
exclusion authority on the employment of excluded individuals, and 
program reimbursement for items and services they may provide to other 
Federal health care programs. Prior to BBA, with limited exceptions, no 
payment could be made under Medicare and the State health care programs 
for any health care item or service furnished, ordered or prescribed by 
an excluded individual. However, an individual excluded from Medicare 
and the State health care programs could still be employed or receive 
payment from other Federal health care programs, such as Tricare or the 
Department of Veterans Affairs. With the expanded scope of the 
exclusion authority, the proposed rule stated that Federal health care 
agencies may neither reimburse for items and services which excluded 
individuals provide, order or prescribe, nor pay the salaries or 
expenses of such persons using Federal funds. As indicated in the 
proposed rule, in accordance with the BBA provision, with limited 
exceptions, an exclusion would effectively preclude the employment of 
an excluded individual in any capacity by a Federal or State agency, or 
other entity, where payment is made by any Federal health care program.
    2. Permanent exclusions for individuals convicted of 3 or more 
health care-related crimes, and 10 year exclusions for individuals 
convicted of 2 health care-related crimes--Most excluded health care 
providers become eligible for reinstatement in the Federal and State 
health care programs after a specified exclusion period. Section 4301 
of BBA established a mandatory exclusion period of not less than 10 
years for individuals who have been twice convicted of mandatory 
exclusion offenses under section 1128(a) of the Act. In addition, a 
permanent program exclusion must be imposed against those individuals 
who have been convicted on 3 or more occasions of such mandatory 
exclusion offenses. Accordingly, we proposed to amend Sec. 1001.102 to 
reflect these new mandatory exclusion periods.
    3. Exclusion of entities controlled by family or household members 
of sanctioned individuals--The OIG is authorized to exclude entities 
owned or controlled by an individual who has been convicted of a health 
care related offense, or who has been sanctioned by the OIG. However, 
some excluded individuals have been able to circumvent the impact of an 
exclusion and retain silent control of operating health care entities 
by engaging in paper transfers of their ownership and control interests 
to family or household members. To address the problem of excluded 
individuals retaining ``silent'' control of participating entities, 
section 4303 of BBA allowed for the exclusion of entities owned or 
controlled by the family or household members of excluded individuals 
when the transfer of ownership or control interest in the entity was 
made in anticipation of, or following, a conviction, CMP or exclusion. 
We proposed to amend Sec. 1001.1001(a) to reflect this new authority.

B. Revised CMP Authorities Resulting From BBA

    1. CMPs against institutional health care providers that employ or 
enter into contracts for medical services with excluded individuals--In 
some instances, individuals who have been excluded from Medicare or the 
State health care programs have been able to obtain (or retain) 
employment, staff privileges or other affiliations with various health 
care entities that then bill the programs for their services. CMP 
authority has existed for health maintenance organizations that submit 
claims for items or services furnished by excluded employees or other 
excluded individuals with whom they contract, but no parallel sanction 
authority existed with respect to a group medical practice, hospital, 
nursing home, home health agency, hospice or other provider that failed 
to check the credentials of individuals whose services they utilize and 
bill to Medicare or State health care programs. In accordance with new 
authority set forth in section 4304(a) of BBA, we proposed amending 
Secs. 1003.102(a) and 1003.103(a) to allow the OIG to impose a CMP of 
up to $10,000 against any entity that submits, or causes to be 
submitted, claims for items or services rendered by employees or other 
individuals with whom they

[[Page 39422]]

contract, and whom they know, or should know, have been excluded from 
participation in the Federal health care programs.
    2. CMP for failure to report information to the Healthcare 
Integrity and Protection Data Bank--Section 221 of HIPAA established a 
national health care fraud and abuse data collection program, the 
Healthcare Integrity and Protection Data Bank (HIPDB), for the 
reporting of final adverse actions (such as convictions, exclusions and 
licensing restrictions) against health care providers, suppliers and 
practitioners.1 While this authority mandated that private 
health plans, as well as certain State and Federal entities, report 
adverse actions to the HIPDB, no penalty provision was included to 
address failure by a health care plan to comply with the reporting 
requirements. In accordance with section 4331(d) of BBA, 
Sec. 1003.102(b) of the proposed regulations set forth a new CMP of not 
more than $25,000 against any health plan that fails to report a final 
adverse action to HIPDB as required by the statute and regulations.
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    \1\  Proposed regulations setting forth the policies and 
procedures for implementing the new HIPDB were published in the 
Federal Register on October 29, 1998 (63 FR 58341).
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    3. CMPs for health care providers who violate the anti-kickback 
statute--Prior to BBA, criminal penalties or program exclusions were 
the only remedies available against those who offered or received 
remuneration in return for the referral of business paid for by Federal 
health care programs, in violation of the anti-kickback statute. Since 
both remedies are potentially quite severe, section 4304 of BBA set 
forth an alternative remedy, i.e., a new CMP for violations of the 
anti-kickback statute. In accordance with this new statutory provision, 
we proposed to amend Secs. 1003.102(b), 1003.103(h) and 1003.104 to 
implement a CMP of not more than $50,000 for each kickback violation, 
and an assessment of up to 3 times the total amount of remuneration 
offered, paid, solicited or received without regard to whether a 
portion of such remuneration was offered, paid, solicited or received 
for a lawful purpose.

C. Additional Technical and Other Revisions to 42 CFR Parts 1001 and 
1003

    1. Technical revisions--A number of proposed technical revisions 
consistent with the policy provisions resulting from BBA and the 
proposed regulatory amendments were also indicated in the notice of 
proposed rulemaking. Specifically, we proposed to amend the authority 
citation cites for parts 1001 and 1003, Secs. 1001.302 (Basis for 
reinstatement), 1003.100 (Basis and purpose), and 1003.114 (Collateral 
estoppel) to reflect the revisions being proposed in accordance with 
the revised BBA exclusion and CMP authorities. In addition, we proposed 
a revision to Sec. 1003.109(a)(3), to delete the phrase ``the amount of 
the proposed penalty, assessment and the period of proposed exclusion 
(where applicable).'' This language appears in paragraph (a)(4) of this 
section, and appears inadvertently in paragraph (a)(3).
    2. Proposed revision to OIG reinstatement considerations--We also 
proposed to add two new elements to Sec. 1001.3002(b), pertaining to 
the OIG's review of an individual's or entity's request for 
reinstatement in the Federal health care programs after the 
individual's or entity's exclusion period. The first new proposed 
element was designed to address the OIG's expectation that excluded 
parties adequately and promptly inform all their clients or patients of 
the exclusion so that the clients or patients will have a clear 
understanding that items and services provided, directed or ordered by 
that individual or entity will not be paid for under any Federal health 
care program. Under Sec. 1001.1901(b) of the proposed regulations, 
Medicare reimbursement is authorized to a beneficiary for the first 
claim submitted for an item or service provided by the excluded party, 
at which time the beneficiary is notified that future claims will be 
denied due to the provider's excluded status. (We did not believe that 
notification only after the submission of a claim provides adequate 
protection for program beneficiaries.) By stating in the proposed 
regulations that the OIG, in making its reinstatement decisions, would 
consider whether a provider has adequately and promptly informed 
clients or patients of an exclusion, we hoped to offer an incentive for 
providers to give the earliest possible notification to beneficiaries 
of their exclusion.
    A second proposed reinstatement element was designed to codify 
existing OIG policy which, in making reinstatement decisions, considers 
whether the individual or entity has, during the period of exclusion, 
submitted claims or caused claims to be submitted, or payments to be 
made by any Federal health care program for items or services the 
excluded party furnished, ordered or prescribed, including health care 
administrative services during the period of exclusion. By setting 
forth this regulatory clarification, we hoped to make clear that the 
submission of claims for payment to any Federal health care program 
during a provider's period of exclusion will jeopardize the provider's 
reinstatement into the programs.

III. Responses to Comments and Summary of Revisions

    In response to the notice of proposed rulemaking, the OIG received 
a total of five timely-filed public comments from various health care 
associations and other interested parties. Set forth below is a 
synopsis of the various comments and recommendations received, our 
response to those concerns, and a summary of the specific revisions and 
clarifications being made to the regulations.

Section 1001.102 Factors in Length of Exclusion

    Comment: Two commenters raised concern over the language in 
proposed Sec. 1001.102(b)(6), one of the possible aggravating factors 
which would provide a basis for lengthening the period of exclusion. 
The provision would consider whether the ``individual or entity has at 
any time been overpaid a total of $1,500 or more by Medicare, Medicaid 
or any Federal health care program as a result of improper billings.'' 
The commenters indicated that this language was too general and gives 
no clear indication of what constitutes ``improper billings.'' The 
commenters stated that any overpayments of $1,500 or more, whether part 
of the same circumstance that led to the exclusion in the first place, 
or ones that are billing error mistakes or simple negligence, could be 
deemed an aggravating circumstance. The commenters indicated that 
aggravating factors should serve as valid predictors of future 
violations of Medicare and other Federal program statutes and 
regulations and, therefore, urged that the OIG delete the $1,500 
threshold.
    Response: It is not our intention to consider overpayment of $1,500 
or more based on inadvertent billing errors as an aggravating 
circumstance. We agree with the commenters that the $1,500 threshold 
for overpayments needs to be related to improper conduct, such as the 
submission of false, fraudulent or otherwise improper claims for 
payment. This criterion with respect to determining aggravating 
circumstances has been included in the OIG's regulations since 1992 and 
has not been identified as a problem by either providers or the OIG. 
Therefore, this provision, which was not proposed for

[[Page 39423]]

any revision in our proposed rule, will not be revised at this time.

Section 1001.3002(b)(5)  Basis for Reinstatement

    Comment: Two commenters raised concern over the proposed language 
in Sec. 1001.3002(b)(5) that would add a new factor in determining 
whether an individual or entity can be reinstated to participate in 
Federally-funded health care programs. Specifically, we indicated that 
the OIG would consider ``whether the individual or entity, during the 
period of exclusion, has adequately and promptly informed its clients 
or patients that any items or services provided will not be 
reimbursable under any Federal health care program.'' One commenter 
requested that the OIG clarify both the terms ``adequate'' and 
``prompt'' so that an excluded individual can be aware of whether they 
have met the criteria for reinstatement. The commenter also asked for 
additional clarification what is meant by a physician's or entity's 
``clients and patients.''
    A second commenter recommended that the language in this paragraph 
be deleted entirely, stating that an excluded party's unwillingness to 
notify those affected should not have a bearing on his or her fitness 
to be readmitted to the health care programs.
    Response: We have considered the comments regarding this proposed 
factor for reviewing reinstatement requests, and agree that this factor 
may impose an additional burden on excluded individuals and entities 
with respect to notification of patients and clients and that this 
notification obligation is not mandated by law. In addition, we are 
persuaded by the fact that beneficiaries are adequately protected, 
since the current procedures provide for payment of the first claim 
submitted by or on behalf of a beneficiary for services furnished, 
ordered or prescribed by an excluded provider or practitioner, and 
simultaneous notification regarding the exclusion. Moreover, we believe 
that it would be very difficult to monitor such notifications by 
excluded individuals and entities in order to assess their 
trustworthiness for purposes of future participation in Federal health 
care programs. Based on these reasons, we are deleting this proposed 
factor from those to be evaluated in assessing a reinstatement request.

Section 1003.102(a)  CMP for Relationships With Excluded Individuals

    Comment: A commenter was concerned that the OIG misinterpreted the 
statute (42 U.S.C. 1320a-7a(a)(6)) and congressional intent with regard 
to the basis for CMPs arising from relationships with excluded 
individuals. They indicated that the proposed regulations imply the 
existence of an affirmative duty on providers to monitor, on an ongoing 
basis, the eligibility of employees and others with whom they enter 
into contracts to participate in the Federal health care programs. The 
commenter believed that the conditional phrase ``or should have known'' 
in proposed Sec. 1003.102(a)(2) would effectively impose a duty upon 
contracting providers to monitor the list of excluded individuals and 
entities on a regular basis or risk imposition of a CMP. The commenter 
raised questions regarding (1) how often should they check on employees 
and contracting parties, e.g., when employees are hired and when 
contracting parties enter into a contract, or rechecked at regular 
intervals), and (2) which persons should be checked, e.g., ongoing 
contracts, subcontractors or employees of a corporation with whom they 
are contracting. The commenter believed the appropriate burden should 
be on the OIG or the excluded individual or entity to notify 
contracting providers with whom they have employment or other 
contractual relationships of their exclusion from the Federal health 
care programs.
    Response: Providers and contracting parties have a duty to check 
the sanction report on the OIG web site prior to entering into 
employment or contractual arrangements with new hires or run the risk 
of CMP liability if they fail to do so. All exclusion information is 
maintained on the OIG web site (www.dhhs.gov/progorg/oig) and updated 
on a regular basis. While it is not possible for the OIG to be aware of 
every employment arrangement being entered into by providers and 
excluded individuals or entities, the OIG does notify and inform 
employers of excluded individuals and entities when such pending 
employment arrangements are specifically known to the OIG. In addition, 
hospitals are under an affirmative obligation to query the National 
Practitioner Data Bank (NPDB) when they grant privileges, and 
subsequently at 2-year intervals, to determine whether any actions have 
been taken against physicians that they employ. Information on 
exclusions is contained in the NPDB.
    Comment: Another commenter contended that use of the OIG's Sanction 
Report posted on the Internet is confusing and inadequate. The 
commenter stated that the current information contained on the OIG web 
site is not easily accessible, requiring providers to create their own 
``cumulative list'' and to manually input data which could leave 
providers open to fraud and abuse claims because of simple mistakes or 
errors. In light of the new CMP authority under BBA for providers 
contracting with or employing an individual or entity that is excluded 
from the Federal health care programs, the commenter requested that the 
OIG reevaluate the current Sanction Report to create a ``cumulative 
list'' of excluded individuals and entities that providers can easily 
access and use.
    Response: We believe that the current OIG web site containing the 
Cumulative Sanction Report is accessible, with large numbers of users 
of this web site having no problems in obtaining the information 
needed. However, we have also been aware that some users want to be 
able to do an on-line search for a single individual or entity, and 
agree that the sanction report on the web site needs to be modified to 
be more user-friendly in order to permit parties to look for one name 
at a time. Early in 1999, the OIG web site was modified so that parties 
can search by either name or location in order to ascertain an 
individual's or entity's exclusion status, as well as being able to 
download the entire file.
    It should also be pointed out that the OIG's web site is not the 
sole source of information regarding sanctioned individuals and 
entities. The NPDB, which hospitals are required to query, contains 
information on our sanctioned providers. In addition, the exclusion 
information is also available on the GSA list of ``Parties Excluded 
from Federal Procurement and Nonprocurement Programs'' and is on-line 
searchable.2 Furthermore, the new HIPDB will contain the OIG 
exclusion information. With the various avenues of information on 
excluded individuals and entities available, we believe parties will be 
able to readily obtain the necessary information on current Federal 
health care program exclusions.
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    \2\ See http://anet.gov/epls/.
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    Comment: The preamble discussion of the proposed rule stated the 
OIG's concern that ``individuals who have been excluded from Medicare 
or State health care program participation have, nonetheless, been able 
to obtain (or retain) employment, staff privileges or other affiliation 
with various health care entities * * *.'' A commenter emphasized that 
it is both possible and common for a physician to have medical staff 
privileges at a hospital without having either an employment or a 
contractual relationship with the

[[Page 39424]]

hospital, particularly in States that prohibit the corporate practice 
of medicine. The commenter further stated that a physician's medical 
staff privileges at a hospital and his or her provision of items and 
services covered by Medicare mean that the hospital and the physician 
are ``arranging'' for the provision of such services.
    Response: We agree with the commenter's point regarding the 
reference to staff privileges. A medical staff relationship, in the 
absence of any employment or contractual relationship or arrangement, 
in and of itself, remains outside the scope of these regulations. 
However, when claims are generated by physicians having privileges in 
the hospital for services they furnish, order or prescribe, the 
hospital must be held accountable if the items or services are provided 
by excluded physicians. Clearly, an excluded physician cannot have any 
Federal or State health care program payments made for items and 
services that they furnish, order or prescribe; not to hold a hospital 
or other organization accountable for allowing such a person to 
generate bills to the programs would be inappropriate.

Section 1003.102(b)  CMP for Failure To Report Information to the HIPDB

    Comment: One commenter believed that the OIG should not proceed 
with regulations relating to the new CMP for failure to report 
information to the HIPDB until the implementing regulations for the new 
data bank have been finalized.
    Response: The OIG published proposed regulations in the Federal 
Register on October 30, 1998 (63 FR 58341) addressing policies and 
procedures for implementing the new HIPDB. Those proposed regulations 
are designed to address, among other things, how and when specific 
information is to be reported to the data bank; the requirements for 
the disclosure and confidentiality of information received by the 
HIPDB; applicable fees when requesting data bank information; and the 
process for disputing the accuracy of HIPDB information. The HIPDB is 
not expected to be operational until final regulations are in place 
some time later this year. The OIG will take no CMP action for failure 
to report information to the HIPDB until the issuance of final 
implementing regulations regarding reporting to he HIPDB.

Section 1003.103  Amount of Penalty

    Comment: One commenter indicated that the proposed regulatory 
language in Sec. 1003.103(h)(1), that indicates that the OIG may impose 
``a penalty of $50,000'' against persons who commit an act in violation 
of the anti-kickback statute, is not consistent with the statutory 
language set forth in BBA. The statutory language (42 U.S.C. 1320a-
7a(a)) indicates that a person may be subject to a civil money penalty 
of not more than * * * $50,000 for each such act.'' The commenter 
recommended that the rule be modified to comport with the statutory 
language.
    Response: We agree that the proposed language was inconsistent, and 
are amending paragraph (h)(1) of this section to indicate that the OIG 
may not impose ``a penalty of not more than $50,000'' (emphasis added).

Section 1003.106  Factors in Calculating CMPs

    Comment: One commenter cited an ambiguity in the preamble and 
proposed regulations text at Sec. 1003.106(a)(1)(vii) with regard to 
determinations on the amount of a penalty. The commenter states that 
the preamble discussion indicates one of the criteria for determining 
the appropriate amount of penalty would be ``whether the contracting 
provider knew or should have known of the exclusion.'' Also, the 
commenter indicates that the proposed language in 
Sec. 1003.106(a)(1)(vii) describes this factor as ``whether the 
contracting provider knew of the exclusion when employing or otherwise 
contracting with an excluded individual or entity.'' The commenter 
recommended adding the word ``actually'' before the word ``knew'' in 
this paragraph.
    The commenter also believed a number of additional factors relating 
to the overall culpability of a contracting party should be considered. 
They included (i) the volume or value of items or services provided by 
an excluded individual or entity with which the contracting provider 
has an employment or contractual relationship; (ii) whether the 
contracting provider has in place an effective compliance program; and 
(iii) the length of time between when the provider knew or should have 
known of the exclusion, and when the provider terminated the employment 
or other contractual relationship with the excluded individual or 
entity.
    Response: In making any determinations regarding the amount of 
penalty, the OIG intends to draw clear distinctions between cases where 
there was actual versus constructive knowledge. As a result, we are 
amending the language in Sec. 1003.106(a)(1)(vii) to indicate that in 
determining the amount of any penalty in accordance with this 
provision, we will take into account whether ``the contracting provider 
actually knew of the exclusion when employing or otherwise contracting 
with an excluded individual or entity * * *'' (emphasis added).
    Comment: Two commenters raised objection to the existing factor, 
being redesignated as paragraph (a)(1)(ix) in this section, which 
allows the OIG to assess penalties in accordance with ``[S]uch other 
matters as justice may require.'' The commenters believe that this 
language is unacceptably vague wide-ranging.
    Response: The language in Sec. 1003.106(a)(1)(ix), among other 
places in part 1003, is not new, and is intended to encompass other 
mitigating and aggravating factors that may arise on a case-by-case 
basis. It was included in the CMP statutory authority when initially 
enacted in 1981. This phrase allows for the consideration of individual 
factors, both aggravating and mitigating, that may be meaningful to one 
distinct case. For example, the additional factors cited by a commenter 
and referenced above, relating to the overall culpability of a 
contracting party, may be considered under this factor.

IV. Provisions of the Final Rule

    For the most part, this final rule incorporates the provisions of 
the September 2, 1998 proposed rule. A brief description of the 
provisions of this final rule follow.
     In Sec. 1001.2, we are adding a definition for the term 
``Federal health care program,'' and are making conforming changes to 
include the term ``and other Federal health care programs'' in 
Secs. 1001.1(a), 1001.201(b)(3)(iii)(A), 1001.301(b)(2)(ii), 
1001.401(c)((2)(ii), 1001.1301(b)(2)(iii), 1001.1401.(b)(1) and (b)(4), 
1001.1501(a)(3), 1001.1901(b)(1), 1001.3003, 1001.303 and 1002.2(a). 
Similar proposed revisions to Secs. 1001.301(b)(3)(ii)(A) and 
1001.401(c)(3)(i)(A) have already been addressed in the OIG final 
regulations published on September 2, 1998 (63 FR 46676) addressing 
revised OIG exclusion authorities resulting from Public Law 104-191.
     In the proposed rule, we set forth in Sec. 1001.2, 
Definitions, a revised definition for the term ``exclusion.'' A revised 
definition of the term was promulgated in the OIG final regulations 
published on September 2, 1998 (63 FR 46676) addressing revised OIG 
exclusion authorities resulting from Public Law 104-191. We are 
retaining that definition of the term ``exclusion,'' set forth in the 
September 2, 1998 final

[[Page 39425]]

rule, in these final regulations as well. We are also adding a 
definition in Sec. 1001.2 for the term ``Federal health care program.''
     The proposed rule indicated our intention to amend 
Sec. 1001.102(b) by revising paragraphs (b)(5) and (b)(6), and by 
adding a new paragraph (b)(7). However, in the proposed rule, we 
inadvertently deleted existing paragraph (b)(5). In addition, final OIG 
regulations published on September 2, 1998 (63 FR 46676) added a new 
paragraph (b)(8). As a result, in these final regulations we are 
revising current paragraphs (b)(6) and (b)(7) (and not (b)(5) and 
(b)(6) as the proposed rule indicated); redesignating the recently-
added paragraph (b)(8) as new paragraph (b)(9); and adding a new 
paragraph (b)(8) (designated as new (b)(7) in the proposed rule). We 
are also adding a new Sec. 1001.102(d) to reflect the new mandatory 
lengths of exclusion.
     We are amending Sec. 1001.1001(a) to reflect the statutory 
authority that allows for the exclusion of entities controlled by 
family or household members of sanctioned individuals. In 
Sec. 1001.1001(a)(2), we are also adding definitions for the terms 
``immediate family member'' and ``member of household,'' consistent 
with the statute.
     To reflect the revised scope of exclusions under title XI 
of the Act, that allows the Secretary, through the OIG, to direct the 
imposition of exclusions from all Federal health care programs and to 
directly impose exclusions from all Federal health care programs, we 
are revising Sec. 1001.1901(a), (b)(1), introductory paragraph (c)(3) 
and (c)(5)(i). While the proposed rule indicated our intention of 
revising paragraph (c)(4)(i) (and not (c)(5)(i)) of this section, the 
OIG final regulations published on September 2, 1998 (63 FR 46676) 
amended paragraph (b)(1), and redesignated paragraph (c)(4) as (c)(5) 
and added a new paragraph (c)(4) in its place. The changes being made 
in Sec. 1001.1901 in this rule reflect the revisions and redesignation 
made in the September 2, 1998 final rule.
     With respect to considerations in the OIG's review of an 
individual's or entity's request for reinstatement in the Federal 
health care programs after the individual's or entity's exclusion 
period, we are not including the language proposed for a new 
Sec. 1001.3002(b)(5) as indicated in the proposed rule. However, we are 
adopting the language proposed for new paragraph (b)(6) of this 
section, and are now designating this as new paragraph (b)(5). 
Technical revisions to Sec. 1001.3002(b)(3) and (b)(4) are also being 
made.
     Sections 1003.102(a)(2) and 1003.103(a) are being revised 
to reflect the new CMP authority against entities that submit, or cause 
to be submitted, claims for health care services rendered by employees 
or other individuals under contract whom they know, or should know, 
have been excluded from participation in the Federal health care 
programs. We are also revising Sec. 1003.106(a)(1) to set forth five 
criteria to be considered in determining the penalty amount.
     We are amending Sec. 1003.102(b)(5) to address CMPs 
imposed against any health plan that fails to report information on an 
adverse action required to be reported to the new HIPDB. Section 
1003.103(g) is being added to set forth the penalty amount for such 
violations.
     A new Sec. 1003.102(b)(11)--to codify the CMP authority 
for health care providers who violate the anti-kickback statute, and a 
new Sec. 1003.103(h), as revised in accordance with the discussion 
above, to address the maximum penalty amount--are being added. Section 
1003.104 is also being revised to address assessments of not more than 
three times the amount of remuneration offered, paid, solicited or 
received with regard to this violation.
     Technical amendments are also being made in 
Secs. 1001.302, 1003.100 and 1003.114 to reflect the regulatory changes 
set forth in the OIG's revised exclusion and CMP authorities revisions 
in accordance with BBA.

V. Regulatory Impact Statement

Executive Order 12866 and Regulatory Flexibility Act

    The Office of Management and Budget (OMB) has reviewed this final 
rule in accordance with the provisions of Executive Order 12866 and the 
Regulatory Flexibility Act (5 U.S.C. 601-612), and has determined that 
it does not meet the criteria for a significant regulatory action. 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when rulemaking is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health, safety distributive 
and equity effects). In addition, under the Regulatory Flexibility Act, 
if a rule has a significant economic effect on a substantial number of 
small entities the Secretary must specifically consider the economic 
effect of a rule on small entities and analyze regulatory options that 
could lessen the impact of the rule.
    The provisions set forth in this final rulemaking implement new or 
revised OIG statutory requirements set forth in Public Law 105-33. 
These provisions are designed both to broaden the scope of the OIG's 
authority to exclude individuals and entities from Medicare, Medicaid 
and all other Federal health care programs, and strengthen current 
legal authorities pertaining to the imposition of CMPs against 
individuals and entities engaged in prohibited actions and activities. 
These regulations implement the new statutory requirements by (1) 
expanding the application of the OIG's exclusions to all Federal health 
care programs; (2) implementing permanent exclusions for individuals 
convicted of three or more offenses for which an exclusion can be 
imposed under section 1128(a) of the Act, and 10 year exclusions for 
individuals convicted of two or more such offenses; (3) allowing for 
the exclusion of entities controlled by family or household members of 
sanctioned individuals; and (4) establishing new CMPs in three specific 
areas.
    With regard to the OIG's new exclusion authorities, the process for 
excluding individuals and entities who are convicted in accordance with 
these new provisions remains essentially the same, even though the 
types of convictions requiring mandatory exclusions have been 
broadened. While there may be a resulting increase in the number of 
mandatory and permissive exclusions imposed as a result of the expanded 
scope of the OIG's exclusion authority, we do not believe these 
increases will be significant. The clarification of exclusion authority 
in Sec. 1001.1001 regarding a sanctioned individual's transfer of 
ownership or control interest to a family or household member, for 
example, should not result in a significant increase in exclusion 
actions in accordance with section 1128(b)(8) of the Act since the 
provision is likely to act as an effective deterrent against the 
occurrence of such transfer arrangements. In addition, we do not 
foresee significant increases resulting from the implementation of 
section 4301 of BBA and Sec. 1001.102, regarding the permanent 
exclusion of individuals convicted of three or more health care related 
crimes. The authority for promulgating this exclusion is clear cut, and 
should limit the total number of repeat exclusions effectuated by the 
OIG against such fraudulent providers.
    The final regulations addressing the new OIG CMPs also remain 
consistent with the congressional intent of BBA and with the OIG's 
existing CMP authority which allows for imposition of

[[Page 39426]]

civil money penalties against individuals and entities who commit 
fraud. These CMPs are targeted to a limited group of individuals and 
entities; that is, those institutional health care providers that 
employ or enter into medical service contracts with excluded 
individuals, health care plans that fail to report information to the 
HIPDB, and health care providers who violate the anti-kickback statute.
    As indicated, these final regulations are narrow in scope and 
effect, comport with congressional and statutory intent, and strengthen 
the Department's legal authorities against those who defraud or 
otherwise act improperly against the Federal and State health care 
programs. Since the vast majority of individuals, organizations and 
entities involved in delivering health care do not engage in the 
prohibited activities and practices described in this rulemaking, we 
believe that the aggregate economic impact of these regulations will 
not be economically significant. Since there is minimal economic effect 
on the industry as a whole, there would be little likelihood of effect 
on Federal or State expenditures to implement these regulations.
    With regard to the effect of these regulations on a substantial 
number of small entities, the provisions are targeted specifically to 
those individuals and entities who would defraud or abuse the health 
care programs, rather than to the health care industry as a whole. 
While some of the perpetrators of fraud effected by this rule may be 
small entities, it is the nature of the violation and not the size of 
the entity that will induce action on the part of the OIG.
    In summary, we have concluded, and the Secretary certifies, that 
since this final rule will not have a significant economic impact on 
Federal, State or local economies and expenditures, nor have a 
significant economic impact on a substantial number of small entities, 
a regulatory flexibility analysis is not required.

Paperwork Reduction Act

    The provisions of these final regulations impose no new reporting 
or recordkeeping requirements necessitating clearance by OMB.

List of Subjects

42 CFR Part 1001

    Administrative practice and procedure, Fraud, Health facilities, 
Health professions, Medicaid, Medicare.

42 CFR Part 1002

    Fraud, Grant programs--health, Health facilities, Health 
professions, Medicaid, Reporting and recordkeeping.

42 CFR Part 1003

    Administrative practice and procedure, Fraud, Grant programs--
health, Health facilities, Health professions, Maternal and child 
health, Medicaid, Medicare, Penalties.
    Accordingly, 42 Parts 1001, 1002 and 1003 is amended as set forth 
below:

PART 1001--[AMENDED]

    1. The authority citation for part 1001 continues to read as 
follows:

    Authority: 42 U.S.C. 1302, 1320a-7, 1320a-7b, 1395u(h), 
1395u(j), 1395u(k), 1395y(d), 1395y(e), 1395cc(b)(2)(D), (E) and 
(F), and 1395hh; and sec. 2455, Pub.L. 103-355, 108 Stat. 3327 (31 
U.S.C. 6101 note).

    2. Section 1001.1 is amended by revising paragraph (a) to read as 
follows:


Sec. 1001.1  Scope and purpose.

    (a) The regulations in this part specify certain bases upon which 
individuals and entities may, or in some cases must, be excluded from 
participation in Medicare, Medicaid and all other Federal health care 
programs. They also state the effect of exclusion, the factors that 
will be considered in determining the length of any exclusion, the 
provisions governing notices of exclusions, and the process by which an 
excluded individual or entity may seek reinstatement into the programs.
* * * * *
    3. Section 1001.2 is amended by adding a definition for the term 
Federal health care program to read as follows:


Sec. 1001.2  Definitions.

* * * * *
    Federal health care program means any plan or program providing 
health care benefits, whether directly through insurance or otherwise, 
that is funded directly, in whole or part, by the United States 
Government (other than the Federal Employees Health Benefits Program), 
or any State health care program as defined in this section.
* * * * *
    4. Section 1001.102 is amended by revising paragraphs (b)(6) and 
(b)(7); redesignating existing paragraph (b)(8) as (b)(9); and by 
adding new paragraphs (b)(8) and (9) to read as follows:


Sec. 1001.102  Length of exclusion.

* * * * *
    (b) * * *
    (6) The convicted individual or entity has a prior criminal, civil 
or administrative sanction record;
    (7) The individual or entity has at any time been overpaid a total 
of $1,500 or more by Medicare, Medicaid or any other Federal health 
care programs as a result of intentional improper billings;
    (8) The individual or entity has previously been convicted of a 
criminal offense involving the same or similar circumstances; or
    (9) *  *  *
* * * * *
    (d) In the case of an exclusion under this subpart, based on a 
conviction occurring on or after August 5, 1997, an exclusion will be--
    (1) For not less than 10 years if the individual has been convicted 
on one other occasion of one or more offenses for which an exclusion 
may be effected under section 1128(a) of the Act (The aggravating and 
mitigating factors in paragraphs (b) and (c) of this section can be 
used to impose a period of time in excess of the 10-year mandatory 
exclusion); or
    (2) Permanent if the individual has been convicted on two or more 
other occasions of one or more offenses for which an exclusion may be 
effected under section 1128(a) of the Act.
    5. Section 1001.201 is amended by revising the heading and 
paragraph (b)(3)(iii)(A) to read as follows:


Sec. 1001.201  Conviction relating to program or health care fraud.

* * * * *
    (b) Length of exclusion. * * *
    (3) * * *
    (iii) * * *
    (A) Others being convicted or excluded from Medicare, Medicaid or 
any of the other Federal health care programs, or
* * * * *
    6. Section 1001.301 is amended by revising paragraphs (b)(2)(ii) to 
read as follows:


Sec. 1001.301  Conviction relating to obstruction of an investigation.

* * * * *
    (b) * * *
    (2) * * *
    (ii) The interference or obstruction had a significant adverse 
mental, physical or financial impact on program beneficiaries or other 
individuals or on the Medicare, Medicaid or other Federal health care 
programs;
* * * * *
    7. Section 1001.401 is amended by revising the heading and 
paragraph (c)(2)(ii) to read as follows:


Sec. 1001.401  Conviction relating to controlled substances.

* * * * *
    (c) * * *

[[Page 39427]]

    (2) * * *
    (ii) The acts that resulted in the conviction or similar acts had a 
significant adverse mental, physical or financial impact on program 
beneficiaries or other individuals or the Medicare, Medicaid or other 
Federal health care programs;
* * * * *
    8. Section 1001.1001 is amended by revising paragraph (a)(1)(ii); 
and by amending paragraph (a)(2) by adding definitions for the terms 
Immediate family member and Member of household to read as follows:


Sec. 1001.1001  Exclusion of entities owned or controlled by a 
sanctioned person.

    (a) * * *
    (1) * * *
    (ii) Such a person--
    (A)(1) Has a direct or indirect ownership interest (or any 
combination thereof) of 5 percent or more in the entity;
    (2) Is the owner of a whole or part interest in any mortgage, deed 
of trust, note or other obligation secured (in whole or in part) by the 
entity or any of the property assets thereof, in which whole or part 
interest is equal to or exceeds 5 percent of the total property and 
assets of the entity;
    (3) Is an officer or director of the entity, if the entity is 
organized as a corporation;
    (4) Is partner in the entity, if the entity is organized as a 
partnership;
    (5) Is an agent of the entity; or
    (6) Is a managing employee, that is, an individual (including a 
general manager, business manager, administrator or director) who 
exercises operational or managerial control over the entity or part 
thereof, or directly or indirectly conducts the day-to-day operations 
of the entity or part thereof, or
    (B) Was formerly described in paragraph (a)(1)(ii)(A) of this 
section, but is no longer so described because of a transfer of 
ownership or control interest to an immediate family member or a member 
of the person's household as defined in paragraph (a)(2) of this 
section, in anticipation of or following a conviction, assessment of a 
CMP, or imposition of an exclusion.
    (2) * * *
    Immediate family member means, a person's husband or wife; natural 
or adoptive parent; child or sibling; stepparent, stepchild, 
stepbrother or stepsister; father-, mother-, daughter-, son-, brother- 
or sister-in-law; grandparent or grandchild; or spouse of a grandparent 
or grandchild. * * *
    Member of household means, with respect to a person, any individual 
with whom they are sharing a common abode as part of a single family 
unit, including domestic employees and others who live together as a 
family unit. A roomer or boarder is not considered a member of 
household.
* * * * *
    9. Section 1001.1301 is amended by revising paragraph (b)(2)(iii) 
to read as follows:


Sec. 1001.1301  Failure to grant immediate access.

* * * * *
    (b) * * *
    (2) * * *
    (iii) The impact of the exclusion on Medicare, Medicaid or any of 
the other Federal health care programs, beneficiaries or the public; 
and
* * * * *
    10. Section 1001.1401 is amended by revising paragraphs (b)(1) and 
(b)(4) to read as follows:


Sec. 1001.1401  Violations of PPS corrective action.

* * * * *
    (b) * * *
    (1) The impact of the hospital's failure to comply on Medicare, 
Medicaid or any of the other Federal health care programs, program 
beneficiaries or other individuals;
* * * * *
    (4) The impact of the exclusion on Medicare, Medicaid or any of the 
other Federal health care programs, beneficiaries or the public; and
* * * * *
    11. Section 1001.1501 is amended by revising paragraph (a)(3) to 
read as follows:


Sec. 1001.1501  Default of health education loan or scholarship 
obligations.

    (a) * * *
    (3) The OIG will take into account access of beneficiaries to 
physicians' services for which payment may be made under Medicare, 
Medicaid or other Federal health care programs in determining whether 
to impose an exclusion.
* * * * *
    12. Section 1001.1901 is amended by revising paragraphs (a), 
(b)(1), (c)(3) introductory text and (c)(5)(i) to read as follows:


Sec. 1001.1901  Scope and effect of exclusion.

    (a) Scope of exclusion. Exclusions of individuals and entities 
under this title will be from Medicare, Medicaid and any of the other 
Federal health care programs, as defined in Sec. 1001.2.
    (b) Effect of exclusion on excluded individuals and entities. (1) 
Unless and until an individual or entity is reinstated into the 
Medicare, Medicaid and other Federal health care programs in accordance 
with subpart F of this part, no payment will be made by Medicare, 
Medicaid or any of the other Federal health care programs for any item 
or service furnished, on or after the effective date specified in the 
notice period, by an excluded individual or entity, or at the medical 
direction or on the prescription of a physician or other authorized 
individual who is excluded when the person furnishing such item or 
service knew or had reason to know of the exclusion. This section 
applies regardless of whether an individual or entity has obtained a 
program provider number or equivalent, either as an individual or as a 
member of a group, prior to being reinstated.
* * * * *
    (c) * * *
    (3) Unless the Secretary determines that the health and safety of 
beneficiaries receiving services under Medicare, Medicaid or any of the 
other Federal health care programs warrants the exclusion taking effect 
earlier, payment may be made under such program for up to 30 days after 
the effective date of the exclusion for--
* * * * *
    (5)(i) Notwithstanding the other provisions of this section, 
payment may be made under Medicare, Medicaid or other Federal health 
care programs for certain emergency items or services furnished by an 
excluded individual or entity, or at the medical direction or on the 
prescription of an excluded physician or other authorized individual 
during the period of exclusion. To be payable, a claim for such 
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 why the items or services could not have been 
furnished by an individual or entity eligible to furnish or order such 
items or services.
* * * * *
    13. Section 1001.3002 is amended by republishing introductory 
paragraph (b) introductory text, revising paragraphs (b)3) and (b)(4); 
adding new paragraph (b)(6); and by revising paragraph (c)(1) to read 
as follows:


Sec. 1001.3002  Basis for reinstatement.

* * * * *
    (b) In making the reinstatement determination, the OIG will 
consider--
* * * * *
    (3) Whether all fines, and all debts due and owing (including 
overpayments) to any Federal, State or local government that relate to

[[Page 39428]]

Medicare, Medicaid and all other Federal health care programs, have 
been paid or satisfactory arrangements have been made to fulfill 
obligations;
    (4) Whether HCFA has determined that the individual or entity 
complies with, or has made satisfactory arrangements to fulfill, all of 
the applicable conditions of participation or supplier conditions for 
coverage under the statutes and regulations; and
* * * * *
    (6) Whether the individual or entity has, during the period of 
exclusion, submitted claims, or caused claims to be submitted or 
payment to be made by any Federal health care program, for items or 
services the excluded party furnished, ordered or prescribed, including 
health care administrative services.
    (c) * * *
    (1) Has properly reduced his or her ownership or control interest 
in the entity below 5 percent;
* * * * *
    14. Section 1001.3003 is revised to read as follows:


Sec. 1001.3003  Approval of request for reinstatement.

    (a) If the OIG grants a request for reinstatement, the OIG will--
    (1) Give written notice to the excluded individual or entity 
specifying the date of reinstatement;
    (2) Notify HCFA of the date of the individual's or entity's 
reinstatement;
    (3) Notify appropriate Federal and State agencies that administer 
health care programs that the individual or entity has been reinstated 
into all Federal health care programs; and
    (4) To the extent applicable, give notice to others that were 
originally notified of the exclusion.
    (b) A determination by the OIG to reinstate an individual or entity 
has no effect if a Federal health care program has imposed a longer 
period of exclusion under its own authorities.
    15. Section 1001.3005 is amended by revising paragraphs (a) 
introductory text, (b) and (d) to read as follows:


Sec. 1001.3005  Reversed or vacated decisions.

    (a) An individual or entity will be reinstated into Medicare, 
Medicaid and other Federal health care programs retroactive to the 
effective date of the exclusion when such exclusion is based on--
* * * * *
    (b) If an individual or entity is reinstated in accordance with 
paragraph (a) of this section, HCFA and other Federal health care 
programs will make payment for services covered under such program that 
were furnished or performed during the period of exclusion.
* * * * *
    (d) An action taken by the OIG under this section will not require 
any other Federal health care program to reinstate the individual or 
entity if such program has imposed an exclusion under its own 
authority.

PART 1002--[AMENDED]

    1. The authority citation for part 1002 continues to read as 
follows:

    Authority: 42 U.S.C. 1302, 1320a-3, 1320a-5, 1320a-7, 
1396(a)(4)(A), 1396(p)(1), 1396a(30), 1396a(39), 1396b(a)(6), 
1396b(b)(3), 1396b(i)(2) and 1396b(q).

    2. Section 1002.2 is amended by revising paragraph (a) to read as 
follows:


Sec. 1002.2  General authority.

    (a) In addition to any other authority it may have, a State may 
exclude an individual or entity from participation in the Medicaid 
program for any reason for which the Secretary could exclude that 
individual or entity from participation in the Medicare, Medicaid and 
other Federal health care programs under sections 1128, 1128A or 
1866(b)(2) of the Social Security Act.
* * * * *

PART 1003--[AMENDED]

    1. The authority citation for part 1003 is revised to read as 
follows:

    Authority: 42 U.S.C. 1302, 1320-7, 1320a-7a, 1320a-7e, 1320b-10, 
1395dd(d)(1), 1395mm, 1395nn(g), 1395ss(d), 1396b(m), 11131(c) and 
11137(b)(2).

    2. Section 1003.100 is amended by revising paragraphs (a) and 
(b)(1)(iv), (viii), (x) and (xi) and adding paragraph (b)(1)(xii) to 
read as follows:


Sec. 1003.100  Basis and purpose.

    (a) Basis. This part implements sections 1128(c), 1128A, 1128E, 
1140, 1876(i)(6), 1877(g), 1882(d) and 1903(m)(5) of the Social 
Security Act, and sections 421(c) and 427(b)(2) of Public Law 99-660 
(42 U.S.C. 1320a-7, 1320a-7a, 1320a-7e, 1320a-7(c), 1320b(10), 1395mm, 
1395ss(d), 1396(m), 11131(c) and 11137(b)(2)).
    (b) * * *
    (1) * * *
    (iv)(A) Fail to report information concerning medical malpractice 
payments or who improperly disclose, use or permit access to 
information reported under part B of title IV of Public Law 99-660, and 
regulations specified in 45 CFR part 60, or
    (B) Are health plans and fail to report information concerning 
sanctions or other adverse actions imposed on providers as required to 
be reported to the Healthcare Integrity and Protection Data Bank 
(HIPDB) in accordance with section 1128E of the Act;
 * * * * *
    (viii) Have submitted, or caused to be submitted, certain 
prohibited claims, including claims for services rendered by excluded 
individuals employed by or otherwise under contract with such person, 
under one or more Federal health care programs;
* * * * *
    (x) Have collected amounts that they know or should know were 
billed in violation of Sec. 411.353 of this title and have not refunded 
the amounts collected on a timely basis;
    (xi) Are physicians or entities that enter into an arrangement or 
scheme that they know or should know has as a principal purpose the 
assuring of referrals by the physician to a particular entity which, if 
made directly, would violate the provisions of Sec. 411.353 of this 
title; or
    (xii) Violate the Federal health care programs' anti-kickback 
statute as set forth in section 1128B of the Act.
* * * * *
    3. Section 1003.102 is amended by revising paragraphs (a)(2) and 
(b)(5); and by adding a new paragraph (b)(11) to read as follows:


Sec. 1003.102  Basis for civil money penalties and assessments.

    (a) * * *
    (2) An item or service for which the person knew, or should have 
known, that the claim was false or fraudulent, including a claim for 
any item or service furnished by an excluded individual employed by or 
otherwise under contract with that person;
* * * * *
    (b) * * *
    (5) Fails to report information concerning--
    (i) A payment made under an insurance policy, self-insurance or 
otherwise, for the benefit of a physician, dentist or other health care 
practitioner in settlement of, or in satisfaction in whole or in part 
of, a medical malpractice claim or action or a judgment against such a 
physician, dentist or other practitioner in accordance with section 421 
of Public Law 99-660 (42 U.S.C. 11131) and as required by regulations 
at 45 CFR part 60; or
    (ii) An adverse action required to be reported to the Healthcare 
Integrity and Protection Data Bank as established by section 221 of 
Public Law 104-191 and set forth in section 1128E of the Act.
* * * * *

[[Page 39429]]

    (11) Has violated section 1128B of the Act by unlawfully offering, 
paying, soliciting or receiving remuneration in return for the referral 
of business paid for by Medicare, Medicaid or other Federal health care 
programs.
* * * * *
    4. Section 1003.103 is amended by revising paragraph (a); and by 
adding new paragraphs (g) and (h) to read as follows:


Sec. 1003.103  Amount of penalty.

    (a) Except as provided in paragraphs (b) and (d) through (h) of 
this section, the OIG may impose a penalty of not more than $10,000 for 
each item or service that is subject to a determination under 
Sec. 1003.102.
* * * * *
    (g) The OIG may impose a penalty of not more than $25,000 against a 
health plan for failing to report information on an adverse action 
required to be reported to the Healthcare Integrity and Protection Data 
Bank in accordance with section 1128E of the Act and 
Sec. 1003.102(b)(5)(ii).
    (h) For each violation of Sec. 1003.102(b)(11), the OIG may 
impose--
    (1) A penalty of not more than $50,000, and
    (2) An assessment of up to three times the total amount of 
remuneration offered, paid, solicited or received, as specified in 
Sec. 1003.104(b).
    5. Section 1003.104 is revised to read as follows:


Sec. 1003.104  Amount of assessment.

    (a) The OIG may impose an assessment, where authorized, in 
accordance with Sec. 1003.102 (except for Sec. 1003.102(b)(11)), of not 
more than three times the amount claimed for each item or service which 
was a basis for the penalty. The assessment is in lieu of damages 
sustained by the Department or a State because of that claim.
    (b) In accordance with Sec. 1003.102(b)(11), the OIG may impose an 
assessment of not more than three times the total amount of 
remuneration offered, paid, solicited or received, without regard to 
whether a portion of such remuneration was offered, paid, solicited or 
received for a lawful purpose.
    6. Section 1003.105 is amended by revising the section heading, 
paragraph (a)(1) introductory text and paragraph (b)(1) to read as 
follows:


Sec. 1003.105  Exclusion from participation in Medicare, Medicaid and 
other Federal health care programs.

    (a)(1) Except as set forth in paragraph (b) of this section, in 
lieu of or in addition to any penalty or assessment, the OIG may 
exclude from participation in Medicare, Medicaid and other Federal 
health care programs the following persons for a period of time 
determined under Sec. 1003.107--
* * * * *
    (b)(1)(i) With respect to determinations under Sec. 1003.102(b)(2) 
or (b)(3), a physician may not be excluded if the OIG determines that 
he or she is the sole community physician or the sole source of 
essential specialized services in a community.
    (ii) With respect to determinations under Sec. 1003.102(b)(5)(ii), 
no exclusion shall be imposed.
* * * * *
    7. Section 1003.106 is amended by redesignating paragraph 
(a)(1)(vii) as paragraph (a)(1)(ix); by adding new paragraphs 
(a)(1)(vii) and (a)(1)(viii); and by revising paragraphs (a)(1)(ii), 
(a)(1)(iii), (a)(1)(vi), (a)(2)(i), (a)(2)(ii) and (a)(2)(iii) to read 
as follows:


Sec. 1003.106  Determinations regarding the amount of the penalty and 
assessment.

    (a) * * *
    (1) * * *
    (ii) The degree of culpability of the contracting provider, or the 
person submitting the claim or request for payment, or giving the 
information;
    (iii) The history of prior offenses of the contracting provider (or 
principals of the contracting provider), or the person submitting the 
claim or request for payment, or giving the information;
* * * * *
    (vi) The amount of financial interest involved with respect to 
Sec. 1003.102(b)(10);
    (vii) Whether the contracting provider actually knew of the 
exclusion when employing or otherwise contracting with an excluded 
individual or entity in accordance with Sec. 1003.102(a)(2);
    (viii) The harm to patients or any Federal or State health care 
program which resulted or could have resulted from the provision of 
care by a person or entity with which the contracting provider is 
expressly prohibited from contracting under section 1128A(a)(6) of the 
Act; and
    (ix) * * *
    (2) * * *
    (i) The nature and circumstances of the failure to properly report 
information, or the improper disclosure of information, as required;
    (ii) The degree of culpability of the person in failing to provide 
timely and complete data or in improperly disclosing, using or 
permitting access to information, as appropriate;
    (iii) The materiality, or significance of omission, of the 
information to be reported, or the materiality of the improper 
disclosure of, or use of, or access to information, as appropriate;
* * * * *
    8. Section 1003.109 is amended by revising paragraph (a) 
introductory text and paragraph (a)(3) to read as follows:


Sec. 1003.109  Notice of proposed determination.

    (a) If the Inspector General proposes a penalty and, when 
applicable, an assessment, or proposes to exclude a respondent from 
participation in Medicare, Medicaid and any other Federal health care 
program, as applicable, in accordance with this part, he or she must 
deliver or send by certified mail, return receipt requested, to the 
respondent, written notice of his or her intent to impose a penalty, 
assessment and exclusion, as applicable. The notice includes--
* * * * *
    (3) The reason why such claims, requests for payments or incidents 
subject the respondent to a penalty, assessment and exclusion;
* * * * *
    9. Section 1003.114 is amended by revising paragraph (a) to read as 
follows:


Sec. 1003.114  Collateral estoppel.

    (a) Where a final determination pertaining to the respondent's 
liability under Sec. 1003.102 has been rendered in any proceeding in 
which the respondent was a party and had an opportunity to be heard, 
the respondent shall be bound by such determination in any proceeding 
under this part.
* * * * *

    Dated: February 4, 1999.
June Gibbs Brown,
Inspector General.

    Approved: April 8, 1999.
Donna E. Shalala,
Secretary.
[FR Doc. 99-18515 Filed 7-21-99; 8:45 am]
BILLING CODE 4150-04-P