[Federal Register Volume 63, Number 57 (Wednesday, March 25, 1998)]
[Proposed Rules]
[Pages 14393-14402]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7506]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of Inspector General

42 CFR Parts 1003, 1005 and 1006

RIN 0991-AA90


Health Care Programs: Fraud and Abuse; Revised OIG Civil Money 
Penalties Resulting From the Health Insurance Portability and 
Accountability Act of 1996

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

ACTION: Notice of proposed rulemaing.

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SUMMARY: This proposed rule would revise the OIG's civil money penalty 
(CMP) authorities, in conjunction with new and revised provisions set 
forth in the Health Insurance Portability and Accountability Act of 
1996. Among other provisions, this proposed rulemaking would codify new 
CMPs for: Excluded individuals retaining ownership or control interest 
in an entity; upcoding and claims for medically unnecessary services; 
offering inducements to beneficiaries; and false certification of 
eligibility for home health services. This rule would also codify a 
number of technical and conforming changes consistent with the OIG's 
existing sanction authorities.

DATES: To assure consideration, public comments must be delivered to 
the address provided below by no later than 5 p.m. on May 26, 1998.

ADDRESSES: Pleas mail or deliver your written comments to the following 
address: Office of Inspector General, Department of Health and Human 
Services, Attention: OIG-25-P, Room 5527 Cohen Building, 330 
Independence Avenue, S.W., Washington, D.C. 20201.

    Because of staffing and resource limitations, we cannot accept 
comments by facsimile (FAX) transmission. In commenting, please refer 
to file code OIG-25-P.
    Comments will be available for public inspection April 8, 1998 in 
Room 5524 of the Office of Inspector General at 330 Independence 
Avenue, S.W., Washington, D.C., on Monday through Friday of each week 
from 8 a.m. to 4:30 p.m., (202) 619-0089.

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

SUPPLEMENTARY INFORMATION:

I. Background

A. Overview of the OIG Civil Money Penalty Authorities

    In 1981, Congress enacted the civil money penalty (CMP) statute, 
section 1128A of the Social Security Act (the Act) (42 U.S.C. 1320a-
7a), as one of several administrative remedies to combat increases in 
health care fraud and abuse. The CMP law authorized the Secretary and 
the inspector General to impose CMPs, assessment and program exclusions 
on individuals and entities whose wrongdoing caused injury to 
Department programs or their beneficiaries. The statutory penalty and 
assessment amounts under section 1128A generally provided for a penalty 
of no more than $2,000 for each item or service at issue, and an 
assessment in lieu of damages of not more than twice the amount 
claimed.
    Since 1981, Congress has greatly expanded the CMP provisions to 
apply to numerous types of fraudulent and abusive activities related to 
Medicare and State health care programs. Specifically, new statutory 
provisions provided the Secretary and the OIG with the authority to 
sanction such improper practices as: (1) Hospitals paying physicians to 
reduce or limit services provided to program beneficiaries; (2) health 
maintenance organizations (HMOs) failing to provide medically necessary 
items and services; (3) individuals and entities engaging in certain 
misleading or fraudulent practices with respect to the marketing and 
selling of supplemental (Medigap) insurance policies; and (4) hospitals 
failing to examine and treat, or to properly transfer, emergency room 
patients (patient dumping).
    In 1987, the Medicare and Medicaid Patient and Program Protection 
Act (MMPPPA), Public Law 100-93, was enacted to improve the ability of 
the Department ``to protect the Medicare and Medicaid programs from 
fraud and abuse, and to protect the beneficiaries of these programs 
from incompetent practitioners and from inappropriate and inadequate 
care.'' The MMPPPA significantly revised and expanded the OIG's CMP and 
exclusion sanction authorities. Final OIG regulations addressing 
amendments to out exclusion and CMP authorities resulting from Public 
Law 100-93 were published in the Federal Register on January 29, 1992 
(57 FR 3298).

B. The Health Insurance Portability and Accountability Act of 1996

    In the first significant amendments to the OIG's sanction 
authorities since MMPPPA, the Health Insurance Portability and 
Accountability Act (HIPAA) of 1996, Public Law 104-191, sets forth a 
number of important improvements to the OIG's authorities intended to 
curtail and eliminate health care fraud and abuse. With regard to the 
sanction authorities, HIPAA expanded the scope of certain basic fraud 
authorities by extending the application of current CMP provisions 
beyond those funded by the Department to include all Federal health 
care programs. The HIPAA also significantly revised and strengthened 
the OIG's existing CMP authorities pertaining to violations under 
Medicare and the State health care programs.
    Among other provisions related to our CMP authority, HIPAA (1) 
increases the maximum penalty amounts per false claim from $2,000 to 
$10,000; (2) allows CMPs to be assessed for incorrect coding, medically 
unnecessary services, and persons offering remuneration to induce a 
program beneficiary to order from a particular provider or supplier 
receiving Medicare or State health care funds; and (3) establishes a 
new CMP for the false certification of eligibility for Medicare-covered 
home health services.
    While the majority of these revisions to the OIG's CMP authorities 
under section 1128A of the Act are effective on January 1, 1997,\1\ 
these provisions do allow the Department some policy discretion in 
their implementation. As a result, we are developing this proposed 
rulemaking to address these HIPAA penalty provisions, along with other 
technical revisions and conforming policy changes to the OIG's sanction 
authorities codified in 42 CFR parts 1003, 1005, and 1006.
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    \1\ Section 232 of HIPAA applies to certifications made on or 
after August 21, 1996, the enactment date of the statute.

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[[Page 14394]]

II. Provisions of the Proposed Rule

A. Extension of Current CMP Authority to All Federal Health Care 
Programs

    Section 231(a) of HIPAA amended section 1128A of the Act to allow 
for the Federal government-wide application of CMPs for false claims to 
other health care programs, as defined in section 1128B(f) of the Act. 
Specifically, under section 231(a), the Medicare and State health care 
programs' CMP authorities for specified fraud and abuse violations, 
like the Medicare criminal statutes, will now apply to similar 
violations involving all Federal health care programs, such as CHAMPUS, 
Veterans, and the Public Health Service programs. (The Federal Employee 
Health Benefits Plan is expressly excluded from this definition of 
``Federal health care program.'')
    As a result, we would amend Secs. 1003.100(b)(1)(i), 
1003.102(a)(3), 1003.109(a), as well as the definitions for the terms 
claim and exclusion set forth in Sec. 1003.101, to apply CMP coverage 
to all applicable Federal government health care programs. The 
definition for the term program currently set forth in Sec. 1003.101 
would also be deleted.

B. Increases in Civil Money Penalty Amounts

    Prior to HIPAA, many of the CMP and assessment amounts authorized 
by section 1128A of the Act, and codified in Sec. 1003.103 of the OIG 
regulations, remained consistent with the penalty and damage amounts 
contained in the False Claims Act (FCA) (31 U.S.C. 3729), and had not 
been revised since the 1986 amendments to that Act. Section 231(c) of 
HIPAA generally increases the amount of authorized CMPs from $2,000 to 
$10,000 per item or service improperly claimed or prohibited practice, 
and raises the authorized assessment amount from double to triple the 
amount claimed. This amendment to the OIG's authorized CMP amounts is 
consistent with the penalty and assessment amounts in the FCA which 
were increased by statute in 1986.
    In accordance with section 231(c) of HIPAA, we are proposing to 
amend Sec. 1003.103(a) to address the increased penalty amount, and 
Sec. 1003.104 to address the revised assessment amount.

C. Clarification of the Knowledge Standard for Civil Money Penalties

    The CMP statute was originally intended to provide an alternative 
administrative enforcement tool when injury to government programs and 
beneficiaries was not redressed through traditional civil or criminal 
remedies. Section 1128A of the Act and our implementing regulations 
have applied the ``knows or should know'' standard of proof for the 
Medicare and State health are programs' CMP provisions regarding false 
claims and other prohibited acts. The term ``should know'' has 
historically placed a duty on health care providers to use ``reasonable 
diligence'' to ensure that claims submitted to Medicare were true and 
accurate. The reason this standard was chosen was that the Medicare 
system relies heavily on the honesty and good faith of providers in 
submitting their claims. (The ``should know'' standard did not impose 
liability for honest mistakes; if the provider exercised reasonable 
diligence and still made a mistake, the provider was not liable.)
    However, to make the knowledge standard consistent with the FCA, 
section 231(d) of HIPAA defined the term ``should know'' to mean 
``reckless disregard'' or ``deliberate ignorance'' of the truth, with 
no proof of specific intent required. Under the newly defined ``should 
know'' standard in these proposed regulations, individuals and entities 
would only be liable if they act with deliberate ignorance or reckless 
disregard of information pertaining to the falsity of a claim or other 
fraud. No specific intent to defraud is required. The terms should know 
and should have known would be specifically defined in Sec. 1003.101, 
with corresponding revisions made in Secs. 1003.100(b)(1)(i) and 
1003.102(a) and (b).
    In addition, we are proposing to add a new paragraph (e) to 
Sec. 1003.102, defining the term ``knowingly,'' to clarify 
congressional intent to apply the FCA standard of knowledge to the 
presentment of a claim under the CMP law.

D. New Civil Money Penalty for Excluded Individuals Retaining Ownership 
or Control Interest in a Participating Entity

    Prior to HIPAA, if an individual retained a direct or indirect 
ownership or control interest in, or had a management role with, a 
health care entity that participates in Medicare or any State health 
care program after the individual had been excluded, the entity itself 
was at risk of exclusion under section 1128(b)(8) of the Act for as 
long as the individual maintained his or her relationship with that 
entity. However, the individual faced no additional liability unless he 
or she filed, or caused to be filed, a claim for reimbursement. This 
created a major loophole through which excluded individuals were often 
able, without penalty, to continue to reap the benefit of participation 
in Medicare and the State health care programs while excluded.
    Section 231(b) of HIPAA specifically set forth new CMP authority 
designed to deter such affiliations by subjecting the excluded 
individual to a CMP of up to $10,000 for each day an excluded 
individual retained a prohibited relationship with a participating 
entity. This new CMP provision is to apply only to those with an 
ownership or control interest in a participating entity who know, or 
should know, of the action constituting the basis for the exclusion, or 
any excluded persons who retain positions as officers or managing 
employees of a participating entity. The imposition of the new CMP 
authority against an excluded individual will prevent excluded parties 
from continuing to benefit from government health care financing 
programs through indirect participation.
    Under Sec. 1003.102, Basis for civil money penalties and 
assessments, we propose to add a new paragraph (b)(11) to codify this 
new authority. Conforming revisions are also being proposed to 
Sec. 1003.100, Basis and purpose, through the addition of a new 
paragraph (b)(1)(xi), and to Sec. 1003.103, Amount of penalty, through 
the addition of a new paragraph (h). In addition, technical changes are 
being proposed to Secs. 1003.105 and 1003.106.

E. New Civil Money Penalties for the Submission of Claims for Upcoding 
and for Medically Unnecessary Services

    The OIG has historically viewed as unlawful under the statute (1) 
the claiming of an inappropriately elevated medical procedure code in 
order to obtain program reimbursement exceeding the amount allowed for 
the item or service rendered (upcoding); (2) a pattern of claiming 
reimbursement for services that an individual or entity knows, or 
should know, are not medically necessary; and (3) the routine waiver of 
Medicare part B copayments and deductibles. To clarify that these 
actions are unlawful practices, section 231(e) of HIPAA expressly 
rendered upcoding and the claiming of medically unnecessary services as 
violations of the CMP statute. (Section 231(h) of HIPAA further 
addressed the practice of routinely waiving deductible and coinsurance 
amounts, and is discussed below in section F.)
    Section 231(e) of HIPAA establishes specific CMP authority for a 
pattern or practice of submitting claims, or causing claims to be 
submitted, based on a code that the person ``knows or should

[[Page 14395]]

know'' will result in greater payment than the code that should have 
been claimed.
    To codify the upcoding prohibition, we would clarify 
Sec. 1003.102(a)(1) of the regulations to indicate that the OIG may 
impose a penalty and assessment against any person it determines has 
presented or caused to be presented a claim for any item or service 
that the person knows, or should have known, was not provided as 
claimed, including any claim that is part of a pattern or practice of 
claims based on upcoding. A new Sec. 1003.102(a)(6) would also be added 
to implement the OIG's authority to impose a CMP and assessment for any 
claim for an item or service that was medically unnecessary and part of 
a pattern or practice of such claims.

F. New Civil Money Penalty for the Offering of Inducements to 
Beneficiaries

    Section 231(h) of HIPAA establishes a new CMP against individuals 
or entities that know, or should know, that offering remuneration or 
inducements to a program beneficiary will influence the patient's 
decision to order or receive any item or service from a particular 
provider, practitioner or supplier reimbursable under Medicare or the 
State health care programs. Remuneration includes both the waiver of 
all or part of the coinsurance and deductible amounts, and ``transfers 
of items and services for free or for other than fair market value.'' 
As a result, we are proposing to add a new Sec. 1003.102(b)(12) to 
codify the new CMP authority for the offering of inducements to 
beneficiaries, with a conforming change also being made with the 
addition of a new Sec. 1003.100(b)(1)(xii). In addition, new factors 
that take into account the degree of culpability and the amount of 
remuneration offered or transferred with respect to this authority are 
also being proposed for inclusion in new Sec. 1003.106(a)(1)(i), 
(a)(1)(vii) and (b)(2)(iv).
    This provision is a separate and distinct authority, completely 
independent of the Medicare and State health care program anti-kickback 
statute (42 U.S.C. 1320a-7b(b)). Specifically, the anti-kickback 
statute is an intent-based statute; that is, in order to provide a 
violation it is necessary to show specific intent to induce referrals 
or orders for services. Under this new CMP authority, individuals and 
entities risk imposition of CMPs if they offer remuneration under 
circumstances where they know or should know that it is likely to 
influence the selection of the health care provider or service.
    For purposes of this provision, we wish to clarify that the 
offering of remuneration or inducements to program beneficiaries (other 
than increased coverage, reduced cost-sharing amounts and reduced 
premium amounts permitted by section 1876 of the Act) to enroll in a 
Medicare or Medicaid managed health care plan would violate this 
statutory provision, as such plans restrict beneficiaries to particular 
providers, practitioners or suppliers.
    Statutory exceptions. There are three statutory exceptions to the 
definition of remuneration in this CMP provision. The first relates to 
waivers for coinsurance and deductibles that meet certain conditions, 
the second is for differentials in coinsurance and deductibles as part 
of a benefits plan design under certain conditions, and the third is 
for incentives given to individuals to promote the delivery of 
preventive care as determined by the Secretary. In accordance with 
section 231(h) of HIPAA, these three exceptions apply only to this CMP 
provision and have no application to the anti-kickback statute.
    The first statutory exception relating to the waiver of coinsurance 
and deductible amounts exempts from this statutory provision waivers to 
indigent beneficiaries or after responsible collection efforts have 
failed.\2\ The second exception relating to differentials in 
coinsurance and deductible amounts as part of a benefits plan design 
applies where (1) The differentials have been disclosed in writing to 
all beneficiaries, third-party payors and providers and (2) the 
differentials meet standards defined by the Secretary. We do not 
interpret the limited exception for differentials as authorizing any 
benefit plan design that directly or indirectly attempts to waive a 
beneficiary's obligation to pay deductible or coinsurance amounts under 
a Federal health care program. For example, a private insurance 
company's ``coordination of benefits'' provision does not operate to 
relieve a provider of its obligation to bill applicable coinsurance 
amounts to Medicare beneficiaries. Of course, a private insurer or 
employer may assume responsibility to pay such deductible or 
coinsurance amounts for its enrollees. At this time, we are choosing 
not to set forth in regulations a definition of differentials in 
coinsurance that are part of a plan design. Rather, we are seeking 
public comments on how best to define these standards in regulations 
for purposes of this provision.
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    \2\ In the Balanced Budget Act of 1997, Pub. L. 105-33, a 
technical correction was made in section 4331(e)(1) to indicate that 
remuneration does not include a waiver of coinsurance and deductible 
amounts that are permissible under section 1128B(b)(3) of the Act or 
in regulations developed by the Secretary.
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    The third exception from the statutory definition of remuneration 
under HIPAA protects incentives given to individuals to promote the 
delivery of preventive care. (However, the exception does not include 
the direct rendering of preventive medical care.) Specifically, the 
exception includes the provision of incentives to individuals who are 
eligible for benefits under a Federal health care program (as defined 
by section 1128B(f) of the Act) where such incentives are provided for 
the purpose of inducing individuals to obtain preventive care. The 
HIPAA requires the Secretary to identify what constitutes ``preventive 
care'' for purposes of this provision. Accordingly, we propose to 
define preventive care within the definition of remuneration at 
Sec. 1003.101 to mean annual physicals and care associated with, and 
integral to, preventing the need for treatment or diagnosis of a 
specific illness, symptom, complaint or injury (including, but not 
limited to, prenatal and postnatal care, flu shots and immunizations 
for childhood diseases, AIDS and HIV testing, mammograms, pap smears 
and prostate cancer screenings, eye examinations, treatment for alcohol 
and drug addiction, and treatment designed to prevent domestic 
violence) where such care is provided or directly supervised by the 
medical provider that has provided the incentive.
    Examples of incentives permitted under this provision would 
include, but would not be limited to, (1) Transportation to and from 
preventive care services; (2) car seats, baby formula and child safety 
devices provided for participating in prenatal or parenting classes; 
and (3) tee shirts, exercise videos and water bottles provided for 
participating in a post-cardiac care fitness program. Examples of 
impermissible incentives would include, but would not be limited to, 
items or services related to the promotion of general health and 
fitness (excluding an annual physical), such as health club 
memberships, nonprescription vitamins, nutritional supplements and 
beauty aids. Also, we believe incentives permitted under section 231(h) 
of HIPAA and these regulations would not include cash (or cash 
equivalents).
    The conference report accompanying this new CMP made it clear that 
``this provision (does) not preclude the provision of items and 
services of nominal value, including, for example,

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refreshments, medical literature, complimentary local transportation 
services, or participation in free health fairs.'' We are interpreting 
this statement to mean that the aggregate value of such services 
provided to any individual must be nominal. Hence, the frequent 
rendering of items and services to any individual may preclude such 
items and services as being classified as nominal in value.

G. New Civil Money Penalty for the False Certification of Eligibility 
for Home Health Services

    Section 232 of HIPAA established a new CMP for false certification 
of eligibility to receive home health care. Specifically, under this 
provision if a physician falsely certifies the medical necessity for 
Medicare-covered home health services, Knowing that the care is not 
necessary, he or she may be subject to a CMP of the greater of $5,000 
or 3 times the amount of the Medicare payments made for the home health 
care services. This provision applies to false certifications made on 
or after August 21, 1996. The new authority would be codified in 
proposed Secs. 1003.100(b)(1)(xiii), 1003.102(b)(13) and 1003.103(g) of 
the regulations.

H. Other Conforming and Technical Regulatory Revisions

    In addition to the changes to the OIG regulations at 42 CFR part 
1003 designed to comply with the revised CMP sanction provisions 
required by HIPAA, we are proposing a number of technical changes in 
part 1003 to clarify and expand the applicability of existing 
regulations and procedures. In addition, with regard to the 
applicability of the appeals of exclusions, CMPs and assessments, 
limited changes are also being proposed in 42 CFR part 1005 with regard 
to motions to compel discovery and interlocutory appeals to the 
Departmental Appeals Board (DAB), and the scope of an administrative 
law judge's (ALJ) authority to issue subpoenas duces tecum is being 
clarified to include the authority to subpoena documents at or prior to 
the administrative hearing.
    Section 1003.100, Basis and purpose--The current language in 
Sec. 1003.100(b)(1)(viii) provides for the imposition of CMPs and, as 
applicable, assessments against persons who have ``submitted certain 
prohibited claims against the Medicare program.'' As a technical 
change, we propose to delete this language and redesignate the existing 
paragraphs accordingly, since many CMPs (including several new CMP 
authorities in HIPAA) do not involve the submission of claims as the 
prohibited conduct.
    Section 1003.102, Basis for civil money penalties and assessments--
We are proposing to delete the current regulatory language currently 
set forth in paragraphs (b)(2) and (b)(3) of this section, and reserve 
these paragraphs. The authority contained in Sec. 1003.102(b)(2) 
addresses CMPs for non-participating physicians billing for actual 
charges in excess of the maximum allowable actual charge. The statutory 
freeze for actual charges exceeding the maximum allowed has expired, 
making this authority no longer valid. Section 1003.102(b)(3) addresses 
CMPs for billing for the services of an assistant at routine cataract 
surgery. As this authority has now been delegated to the Health Care 
Financing Administration, we are proposing to delete it from the OIG 
regulations. Conforming changes would also be made through the deletion 
of paragraphs (c) and (e) in Sec. 1003.107.
    Section 1003.103, Amount of penalty; and section 1003.105, 
Exclusion from participation in Medicare and State Health care 
programs--We are proposing to update the regulatory language currently 
set forth in Secs. 1003.103(e) and 1003.105(a)(1), relating to patient 
anti-dumping provisions, consistent with the statutory amendments to 
the knowledge standard and penalty amounts.
    Section 1003.106, Determinations regarding the amount of the 
penalty and assessment--We are proposing to broaden the language in 
paragraph (a)(1) of this section to include all existing and new CMP 
authorities. In addition, we would amend Sec. 1003.106(b)(5), the 
factor addressing financial condition, by deleting the first sentence 
in this paragraph. The current language indicates that it should be 
considered a mitigating circumstance ``if the imposition of the penalty 
or assessment without reduction will jeopardize the ability of the 
respondent to continue as a health care provider;; (underling added). 
Since this penalty authority is intended to apply not only to direct 
providers of health care, but also to those involved in other related 
activities and positions (such as a transporter of patients or a CEO of 
a drug company), we believe this factor does not represent a generally 
applicable standards, and therefore propose deleting this factor.
    Section 1003.107, Determinations regarding exclusions--We would 
amend paragraph (b) of this section to incorporate reference to the new 
CMP authorities being set forth in Sec. 1003.102(b) (11) and (12) 
referenced above.
    Section 1005.1. Definitions--While the terms ``OIG'' and 
``Inspector General'' are defined, respectively, at the beginning of 
parts 1001 and 1003, part 1005 does not currently set forth such a 
definition. We would revise the definitions section of part 1005 to 
include a definition for the term ``Inspector General.''
    Section 1005.7. Discovery--We are proposing a revision to 
Sec. 1005.7(e) to provide for motions to compel discovery once a 
request for production of documents has been received. Presently, the 
language in paragraph (e) states that ``[A]fter a party has been served 
with a request for production of documents, that party may file for a 
protective order.'' However, there is no provision currently 
authorizing a motion to compel requested discovery. Thus, the burden is 
now on the person who wishes to withhold requested documents to file a 
motion, instead of upon the party who has requested the documents, and 
who can best explain their relevance. As in the Federal Rules of Civil 
Procedure, we believe that motions to compel discovery should be 
authorized by these administrative hearing regulations, so that the 
party requesting discovery will be responsible for invoking a judicial 
determination of a discovery dispute. The revision we propose would 
allow either party to object to discovery requests, and if a motion to 
compel is filed, a request for a protective order may be requested in 
response.
    Specifically, we would revise Sec. 1005.7(e) to make clear that a 
party has a right to object to discovery requests without requiring 
that party to file for a protective order, leaving it to the party 
seeking the documents to justify why access is appropriate in a motion 
to compel discovery. Any objections to production of documents would 
have to be filed with the opposing party within 15 days of receiving 
the discovery request. The party seeking the production of documents 
may then file a motion to compel discovery within the next 15 days or 
any other time frame set by the ALJ. We welcome comments on this 
clarifying change.
    Section 1005.9. Subpoenas for attendance at hearing--We would 
revise paragraph (b) of Sec. 1005.9 to clarify that this provision is 
intended to authorize an administrative law judge to issue a subpoena 
to any individual to attend the hearing and to provide documentary 
evidence at or prior to the hearing. The existing language in this 
section has been misconstrued in some instances as only authorizing the 
production of documents at the hearing. We are clarifying this language 
to

[[Page 14397]]

indicate that an ALJ may issue a subpoena duces tecum requiring 
documents to be produced before the hearing. We believe the proposed 
language should fully clarify the intent of this provisions.
    Section 1005.15, The hearing and burden of proof--Section 1005.2(b) 
of the regulations defines a ''respondent'' as the party appealing a 
CMP, and a ``petitioner'' as the party appealing an exclusion. The 
existing language in paragraph (b) of Sec. 1005.15, however, currently 
incorrectly uses the term ``respondent'' to refer to several exclusion 
authorities. We propose revising Sec. 1005.15(b) to make the language 
in this paragraph consistent with the way parties are currently defined 
in Sec. 1005.2(b).
    Section 1005.21, Appeal to DAB--We would revise the current 
language in paragraph (d) of this section to allow for interlocutory 
appeals to the DAB in one limited situation; that is, on the timeliness 
of filing of the hearing request. Otherwise, in many cases a final 
ruling on the timeliness of a hearing request will be rendered 
meaningless because the hearing will take place before an appeal of an 
appeal of an ALJ's ruling on timeliness can occur.
    Deletion of reference to the Office of the General Counsel in 
Secs. 1003.126, 1003.128 and 1006.4--We would make a technical revision 
in Secs. 1003.126, 1003.128(b) and 1006.4(b)(2) by deleting the current 
reference to ``the Office of the General Counsel.'' Section 1003.126 
gives the Office of the General Counsel (OGC) the exclusive authority 
to settle a case prior to a final decision of the Secretary. Paragraph 
(b) of Sec. 1003.128 authorizes the OGC ``after consultation with the 
IG'' to compromise any penalty and assessment imposed by the Secretary. 
Section 1006.4(b) addresses attendance at investigational inquiries. 
The current language indicates that both representatives of the OIG and 
the OGC may attend and ask questions. With the consolidation of the IG 
Division of Office of the General Counsel into the OIG, these 
references to the OGC are no longer appropriate, and the regulatory 
language should be revised to give the OIG exclusive authority to 
settle or compromise cases, and to attend investigational inquiries.

III. Regulatory Impact Statement

Executive Order 12866 and Regulatory Flexibility Act

    The Office of Management and Budget (OMB) has reviewed this 
proposed 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 number of businesses the Secretary must specifically consider the 
economic effect of a rule on small business entities and analyze 
regulatory options that could lessen the impact of the rule.
    As indicated above, the provisions contained in this proposed 
rulemaking are primarily intended to comply with amended statutory 
authority by (1) expanding the protection of certain basic fraud 
authorities beyond the Department to include other Federal health care 
programs, (2) strengthening current legal authorities pertaining to our 
imposition of CMPs against individuals and entities engaged in 
prohibited actions and activities, and (3) codifying other new and 
revised OIG sanction authorities set forth in Public Law 104-191.
    We believe that these regulations will not have a significant 
ecomonic effect on Federal, State or local economies, nor will they 
have a significant economic effect on a substantial number of small 
entities. The CMP statute, as enacted by Congress in 1981, was an 
administrative remedy to combat increases in health care fraud. The CMP 
provisions have been expanded upon since their original enactment to 
counteract evolving fraudulent and abusive practices. These proposed 
regulations merely continue the approach of authorizing CMP sanctions 
against individuals and entities that abuse Federal and State health 
care programs as emerging fraudulent practices are identified. These 
remedial sanctions are addressed to a limited group of individuals and 
entities; that is, providers who abuse the Federal health care programs 
to the detriment of the beneficiaries and the public fisc.
    The revised CMP provisions set forth in this proposed rule that 
address the upcoding of claims, and claims for medically unnecessary 
services, are essentially clarifications of existing OIG authorities. 
In addition, with respect to the new penalty authorities being 
codified, such as the CMP for excluded individuals retaining ownership 
or control interest in an entity and the CMP for the false 
certification of eligibility for home health services, these provisions 
target egregious conduct that is limited in scope and nature.
    The proposed regulations would implement congressional intent in 
the area of fraud and abuse in health care programs. The regulations 
target areas of fraud, not industry; the scope of effect is narrow and 
targeted specifically to those individuals defrauding or abusing the 
Medicare and State health care programs. There should be no increase in 
paperwork or reporting burdens in any pre-existing programs as a result 
of these regulations.
    Similarly, while increases in the authorized CMP amounts from 
$2,000 to $10,000 per false item or service claimed or prohibited 
practice may increase overall penalty amounts and recoveries, the 
process for deriving any settlement will remain essentially the same. 
While the rise in the amount of penalty from $2,000 to $10,000 is an 
increase, it is only proportionate to the amount of fraud against the 
public fisc. It also serves as a deterrent to health care fraud, 
consistent with congressional intent in the enactment of HIPAA. This 
penalty amount increase should not significantly affect the health case 
industry; the only effect is remedial against those who perpetrate 
fraud against the system and thus violate Federal and State law. This 
increased maximum amount per false claim or prohibited practice may, in 
certain circumstances, reduce OIG investigative costs since fewer 
individual false claims will need to be developed and proved in order 
for the Government to recover appropriate penalties and assessments. In 
addition, we believe settlements with individuals and entities may 
become more likely since the OIG's bargaining power is now enhanced in 
the face of greater potential financial exposure for the individual or 
entity.
    Overall, we believe that any increase in CMP recoveries will not be 
significant since the vast majority of individuals, organizations and 
entities addressed by these regulations do not engage in such 
prohibited activities and practices. As indicated, these proposed 
regulations are narrow in scope and effect, serve to codify or revise 
existing OIG sanctions, comport with congressional and statutory 
intent, and strengthen the Department legal authorities against those 
who defraud or otherwise act improperly against the Federal and State 
health care program. Since there is no significant economic effect on 
the industry as a whole, there is little likelihood of effect on 
Federal or State expenditures to implement these

[[Page 14398]]

regulations. While some sanctions addressed in this rule may have a 
minor impact on small entities, it is the nature of the violation and 
not the size of the entity that will result in an action by the OIG. In 
conclusion, we believe that the aggregate economic impact of these 
regulations will be minimal, affecting only those limited few who have 
chosen to engage in prohibited arrangements, schemes and practices in 
violation of statutory intent. As a result, we have conducted, and the 
Secretary certifies, that this proposed rule should not have a 
significant economic impact on a substantial number of small entities 
that would require a regulatory flexibility analysis.

Paperwork Reduction Act

    This proposed rule would impose no new reporting or recordkeeping 
requirements necessitating clearance by OMB.

List of Subjects

42 CFR Part 1003

    Administrative practice and procedure, Fraud, Grant programs--
health, Health facilities, Health professions, Maternal and child 
health, Medicaid, Medicare, Penalties.

42 CFR Part 1005

    Administrative practice and procedure, Fraud, Penalties.

42 CFR Part 1006

    Administrative practice and procedure, Fraud, Investigations, 
Penalties.

    Accordingly, 42 CFR Parts 1003, 1005 and 1006 is proposed to be 
amended as set forth below:

PART 1003--[AMENDED]

    A. Part 1003 would be amended as follows:
    1. The authority citation for part 1003 would be revised to read as 
follows:

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

    2. Section 1003.100 would be revised to read as follows:


Sec. 1003.100  Basis and purpose.

    (a) Basis. This part implements sections 1128(c), 1128A, 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 Pub.L. 99-660 (42 U.S.C. 1320a-7, 
1320a-7a,1320a-7(c), 1320b(10), 1395mm, 1395ss(d), 1396b(m), 11131(c) 
and 11137(b)(2)).
    (b) Purpose. This part--
    (1) Provides for the imposition of civil money penalties and, as 
applicable, assessments against persons who--
    (i) Have knowingly submitted certain prohibited claims under 
Federal health care programs;
    (ii) Seek payment in violation of the terms of an agreement or a 
limitation on charges or payments under the Medicare program, or a 
requirement not to charge in excess of the amount permitted under the 
Medicaid program;
    (iii) Give false or misleading information that might affect the 
decision to discharge a Medicare patient from the hospital;
    (iv) 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;
    (v) Misuse certain Departmental and Medicare and Medicaid program 
words, letters symbols or emblems;
    (vi) Violate a requirement of section 1867 of the Act Sec. 489.24 
of this title;
    (vii) Substantially fail to provide an enrollee with required 
medically necessary items and services, or engage in certain marketing, 
enrollment, reporting, claims payment, employment or contracting 
abuses, or that do not meet the requirements for physician incentive 
plans for Medicare specified in Secs. 417.479(d) through (f) of this 
title;
    (viii) Present or cause to be presented a bill or claim for 
designated health services (as defined in Sec. 411.351 of this title) 
that they know, or should know, were furnished in accordance with a 
referral prohibited under Sec. 411.353 of this title;
    (ix) Have collected amounts that they know or should know were 
billed in violation of Sec. 422.353 of this title and have not refunded 
the amounts collected on a timely basis;
    (x) 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;
    (xi) Are excluded, and who retain an ownership or control interest 
of five percent or more in an entity participating in Medicare or a 
State health care program, or who are officers or managing employees of 
such an entity (as defined in section 1126(b) of the Act);
    (xii) Offer inducements to influence Medicare or State health care 
program beneficiaries to order or receive particular items or services; 
or
    (xiii) Are physicians who knowingly misrepresent that a Medicare 
beneficiary requires home health services;
    (2) Provides for the exclusion of persons from the Medicare or 
State health care programs against whom a civil money penalty or 
assessment has been imposed, and the basis for reinstatement of persons 
who have been excluded; and
    (3) Sets forth the appeal rights of persons subject to a penalty, 
assessment and exclusion.
    3. Section 1003.101 would be amended by republishing the 
introductory text; by revising the definition for the terms Claim and 
Exclusion; by removing the terms General Counsel and Program; and by 
adding, in alphabetical order, definitions for the terms Remuneration 
and Should know, or should have known to read as follows:


Sec. 1003.101  Definitions.

    For purposes of this part:
* * * * *
    Claim means an application for payment for an item or service to a 
Federal health care program (as defined in section 1128B(f) of the 
Act).
* * * * *
    Exclusion means the temporary or permanent barring of a person from 
participation in a Federal health care program (as defined in section 
1128B(f) of the Act).
* * * * *
    Remuneration, as set forth in Sec. 1003.102(b)(12), is consistent 
with the definition contained in section 1128A(i)(6) of the Act. For 
purposes of this definition of remuneration, preventive care means 
annual physicals and care associated with, and integral to, preventing 
the need for treatment or diagnosis of a specific illness, symptom, 
complaint or injury.
* * * * *
    Should know or should have known means that a person, with respect 
to information--
    (1) Acts in deliberate ignorance of the truth or falsity of the 
information; or
    (2) Acts in reckless disregard of the truth or falsity of the 
information.
    For purposes of this definition no proof of specific intent to 
defraud is required.
* * * * *
    4. Section 1003.102 would be amended by revising the introductory 
text of paragraph (a) and paragraphs (a)(1) and (a)(3); republishing 
the introductory text of paragraph (a)(4) and revising paragraphs 
(a)(4)(iii) and paragraph (a)(5); adding a new

[[Page 14399]]

paragraph (a)(6); republishing the introductory text of paragraph (b) 
and revising introductory paragraph (b)(1); removing and reserving 
paragraphs (b)(2) and (b)(3); revising paragraphs (b)(4) and (b)(9); 
and by adding new paragraphs (b)(11) through (b)(13) and (e) to read as 
follows:


Sec. 1003.102   Basis for civil money penalties and assessments.

    (a) The OIG may impose a penalty and assessment against any person 
whom it determines in accordance with this part has knowingly 
presented, or caused to be presented, a claim which is for--
    (1) An item or service that the person knew, or should have known, 
was not provided as claimed, including a claim that is part of a 
pattern or practice of claims based on codes that the person knows or 
should know will result in greater payment to the person than the code 
applicable to the item or service actually provided;
* * * * *
    (3) An item or service furnished during a period in which the 
person was excluded from participation in the Federal health care 
program to which the claim was made;
    (4) A physician's services (or an item or service) for which the 
person knew, or should have known, that the individual who furnished 
(or supervised the furnishing of) the service--
* * * * *
    (iii) Represented to the patient at the time the service was 
furnished that the physician was certified in a medical specialty board 
when he or she was not so certified;
    (5) A payment that such person knows, or should know, may not be 
made under Sec. 411.353 of this title; or
    (6) An item or service that is medically unnecessary, and which is 
part of a pattern or practice of such claims.
    (b) The OIG may impose a penalty, and where authorized, an 
assessment against any person (including an insurance company in the 
case of paragraphs (b)(5) and (b)(6) of this section) whom it 
determines in accordance with this part--
    (1) Has knowingly presented or caused to be presented a request for 
payment in violation of the terms of--
* * * * *
    (4) Has knowingly given or caused to be given to any person, in the 
case of inpatient hospital services subject to the provisions of 
section 1886 of the Act, information that he or she knew, or should 
have known, was false or misleading and that could reasonably have been 
expected to influence the decision when to discharge such person or 
another person from the hospital.
* * * * *
    (9) Has not refunded on a timely basis, as defined in 
Sec. 1003.101, amounts collected as the result of billing an 
individual, third party payer or other entity for a designated health 
service that was provided in accordance with a prohibited referral as 
described in Sec. 411.353 of this title.
* * * * *
    (11) Who is not an organization, agency or other entity, and who is 
excluded from participating in Medicare or a State health care program 
in accordance with sections 1128 or 1128A of the Act, and who--
    (i) Knows or should know of the action constituting the basis for 
the exclusion, and retains a direct or indirect ownership or control 
interest of five percent or more in an entity that participates in 
Medicare or a State health care program; or
    (ii) Is an officer or managing employee (as defined in section 
1126(b) of the Act) of such entity.
    (12) Offers or transfers remuneration (as defined in section 
1128(i)(6) of the Act) to any individual eligible for benefits under 
Medicare or a State health care program, that such person knows or 
should know is likely to influence such individual to order or to 
receive from a particular provider, practitioner or supplier any item 
or service for which payment may be made, in whole or in part, under 
Medicare or a State health care program.
    (13) Is a physician and who executes a document falsely by 
certifying that a Medicare beneficiary requires home health services 
when the physician knows that the beneficiary does not meet the 
eligibility requirements set forth in sections 1814(a)(2)(C) or 
1835(a)(2)(A) of the Act.
* * * * *
    (e) For purposes of this section, the term ``knowingly'' is defined 
consistent with the definition set forth in the Civil False Claims Act 
(31 U.S.C. 3729(b)).
    5. Section 1003.103 would be amended by revising paragraphs (a) and 
(e); 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) through (h) of this 
section, the OIG may impose a penalty of not more than--
    (1) $2,000 for each wrongful act occurring before January 1, 1997 
that is subject to a determination under Sec. 1003.102; and
    (2) $10,000 for each wrongful act occurring on or after January 1, 
1997 that is subject to a determination under Sec. 1003.102.
* * * * *
    (e) For violations of section 1867 of the Act or Sec. 489.24 of 
this title, the OIG may impose--
    (1) Against each participating hospital with an emergency 
department, a penalty of not more than $50,000 for each negligent 
violation occurring on or after May 1, 1991, except that it the 
participating hospital has fewer than 100 State-licensed, Medicare-
certified beds on the date the penalty is imposed, the penalty will not 
exceed $25,000; and
    (2) Against each responsible physician, a penalty of not more than 
$50,000 for each negligent violation occurring on or after May 1, 1991.
* * * * *
    (g) For violations of Sec. 1003.102(b)(3) the OIG may impose a 
penalty of not more than the greater of--
    (1) $5,000; or
    (2) Three times the amount of Medicare payments for home health 
services that are made with regard to the false certification of 
eligibility by a physician in accordance with sections 1814(a)(2)(C) or 
1835(a)(2)(A) of the Act.
    (h) The OIG may impose a penalty of not more than $10,000 per day 
for each day that the prohibited relationship described in 
Sec. 1003.102(b)(11) occurs. 6.
    6. Section 1003.104 would be 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, of not more than--
    (1) Two times the amount for each item or service wrongfully 
claimed prior to January 1, 1997; and
    (2) Three times the amount for each item or service wrongfully 
claimed on or after January 1, 1997.
    (b) The assessment is in lieu of damages sustained by the 
Department or a State agency because of that claim.
    7. Section 1003.105 would be amended by revising paragraph (a)(1); 
removing existing paragraph (b)(1); and by redesignating existing 
paragraphs (b)(2) and (b)(3) respectively as new paragraphs (b)(1) and 
(b)(2) to read as follows:


Sec. 1003.105  Exclusion from participation in Medicare and State 
health care programs.

    (a)(1) Except as set forth in paragraph (b) of this section, the 
following persons may be subject, in lieu of or in addition to any 
penalty or assessment, to an exclusion from participation in Medicare 
for a period of time determined under Sec. 1003.107. There will be 
exclusions from State health care

[[Page 14400]]

programs for the same period as the Medicare exclusion for any person 
who--
    (i) Is subject to a penalty or assessment under Sec. 1003.102(a), 
(b)(1), (b)(4), (b)(11) or (b)(12); or
    (ii) Commits a gross and flagrant, or repeated, violation of 
section 1867 of the Act or Sec. 489.24 of this title on or after May 1, 
1991. For purposes of this section, a gross and flagrant violation is 
one that presents an imminent danger to the health, safety or well-
being of the individual who seeks emergency examination and treatment 
or places that individual unnecessarily in a high-risk situation.
* * * * *
    8. Section 1003.106 would be amended by revising paragraph (a)(1); 
republishing the introductory text of paragraph (b) and revising 
paragraphs (b)(2) and (b)(5); revising the introductory text of 
paragraph (c) and paragraph (c)(3); redesignating existing paragraphs 
(d) and (e) as new paragraphs (e) and (f); revising the introductory 
text of new redesignated paragraph (e); and by adding a new paragraph 
(d) to read as follows:


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

    (a) Amount of penalty. (1) In determining the amount of any penalty 
or assessment in accordance with Sec. 1003.102(a), (b)(1), (b)(4) and 
(b)(9) through (b)(13), the Department will take into account--
    (i) The nature of the claim, referral arrangement or other 
wrongdoing;
    (ii) The degree of culpability of the person against whom a civil 
money penalty is proposed;
    (iii) The history of prior offenses of the person against whom a 
civil money penalty is proposed;
    (iv) The financial condition of the person against whom a civil 
money penalty is proposed;
    (v) The completeness and timeliness of the refund with respect to 
Sec. 1003.102(b)(9);
    (vi) The amount of financial interest involved with respect to 
Sec. 1003.102(b)(11);
    (vii) The amount of remuneration offered or transferred with 
respect to Sec. 1003.102(b)(12); and
    (viii) Such other matters as justice may require.
* * * * *
    (b) Determining the amount of the penalty or assessment. As 
guidelines for taking into account the factors listed in paragraph 
(a)(1) of this section, the following circumstances are to be 
considered--
* * * * *
    (2) Degree of culpability. It should be considered a mitigating 
circumstance if the claim or request for payment for the item or 
service was the result of an unintentional and unrecognized error in 
the process the respondent followed in presenting claims or requesting 
payment, and corrective steps were taken promptly after the error was 
discovered. It should be considered an aggravating circumstance if--
    (i) The respondent knew the item or service was not provided as 
claimed or if the respondent knew that the claim was false or 
fraudulent;
    (ii) The respondent knew that the items or services were furnished 
during a period that he or she had been excluded from participation and 
that no payment could be made as specified in Secs. 1003.102(a)(3) and 
1003.102(b)(11), or because payment would violate the terms of an 
assignment or an agreement with a State agency or other agreement or 
limitation on payment under 1003.102(b);
    (iii) The respondent knew that the information could reasonably be 
expected to influence the decision of when to discharge a patient from 
a hospital; or
    (iv) The respondent knew that the offer or transfer or remuneration 
described in 1003.102(b)(12) would influence a beneficiary to order or 
receive particular items or services under Medicare or a State health 
care program.
* * * * *
    (5) Final condition. In all cases, the resources available to the 
respondent will be considered when determining the amount of the 
penalty and assessment.
* * * * *
    (c) In determining the amount of the penalty and assessment to be 
imposed for every item or service or incident subject to a 
determination under Secs. 1003.102 (a), (b)(1) and (b)(4)--
* * * * *
    (3) Unless there are extraordinary mitigating circumstances, the 
aggregate amount of the penalty and assessment should never be less 
than double the approximate amount of damages and costs (as defined in 
paragraph (f) of this section) sustained by the United States, or any 
State, as a result of claims or incidents subject to a determination 
under Secs. 1003.102 (a), (b)(1) and (b)(4).
    (d) In considering the factors listed in paragraph (a)(4) of this 
section for violations subject to a determination under 
Sec. 1003.103(e), the following circumstances are to be considered, as 
appropriate, in determining the amount of any penalty--
    (1) Degree of culpability. It would be a mitigating circumstance if 
the respondent hospital had appropriate policies and procedures in 
place, and had effectively trained all of its personnel in the 
requirements of section 1867 of the Act and Sec. 489.24 of this title, 
but an employee or responsible physician acted contrary to the 
respondent hospital's policies and procedures.
    (2) Seriousness of individual's condition. It would be an 
aggravating circumstance if the respondent's violation(s) occurred with 
regard to an individual who presented to the hospital a request for 
treatment of a medical condition that was clearly an emergency, as 
defined by Sec. 489.24(b) of this title.
    (3) Prior offenses. It would be an aggravating circumstance if 
there is evidence that at any time prior to the current violation(s) 
the respondent was found to have violated any provision of section 1867 
of the Act or Sec. 489.24 of this title.
    (4) Financial condition. In all cases, the resources available to 
the respondent would be considered when determining the amount of the 
penalty. A respondent's audited financial statements, tax returns or 
financial disclosure statements, as appropriate, will be reviewed by 
OIG auditors to make a determination with respect to the respondent's 
financial condition.
    (5) Nature and circumstances of the incident. It would be 
considered a mitigating circumstance if an individual presented a 
request for treatment, but subsequently exhibited conduct that 
demonstrated a clear intent to leave the respondent hospital 
voluntarily. In reviewing such circumstances, the OIG would evaluate 
the respondent's efforts to--
    (i) Provide the services required by section 1867 of the Act and 
Sec. 489.24 of this title, despite the individual's withdrawal of the 
request for examination or treatment; and
    (ii) Document any attempts to inform the individual (or his or her 
representative) of the risks of leaving the respondent hospital without 
receiving an appropriate medical screening examination or treatment, 
and obtain informed consent from the individual (or his or her 
representative) prior to the individual's departure from the respondent 
hospital.
    (6) Other matters as justice may require. (i) It would be 
considered a mitigating circumstance if the respondent hospital--
    (A) Developed and implemented a corrective action plan;

[[Page 14401]]

    (B) Took immediate appropriate action against any hospital 
personnel or responsible physician who violated section 1867 of the Act 
or Sec. 489.24 of this title prior to any investigation of the 
respondent hospital by HCFA; or
    (C) Is a rural or county-owned facility that is faced with severe 
physician staffing and financial deficiencies.
    (ii) It would be considered an aggravating circumstance if an 
individual was severely harmed or died as a result of the respondent's 
violation of section 1867 of the Act or Sec. 489.24 of this title.
    (iii) Other circumstances of an aggravating or mitigating nature 
will be taken into account if, in the interests of justice, they 
require either a reduction of the penalty or an increase in order to 
assure the achievement of the purposes of this part.
    (e) In considering the factors listed in paragraph (a)(5) of this 
section for violations subject to a determination under 
Sec. 1003.103(f), the following circumstances are to be considered, as 
appropriate, in determining the amount of any penalty--
* * * * *
    9. Section 1003.107 would be amended by revising paragraph (b); 
removing existing paragraph (c) and (e); redesignating paragraph (d) as 
new paragraph (c) and revising it to read as follows:


Sec. 1003.107  Determinations regarding exclusion.

* * * * *
    (b) With respect to determinations to exclude a person under 
Secs. 1003.102(a), (b)(1), (b)(4), (b)(11), or (b)(12), the Department 
considers those circumstances described in Sec. 1003.106(b). Where 
there are aggravating circumstances with respect to such 
determinations, the person should be excluded.
    (c) The guidelines set forth in this section are not binding. 
Nothing in this section limits the authority of the Department to 
settle any issue or case as provided by Sec. 1003.126.
    10. Section 1003.109 would be amended by revising the introductory 
text of paragraph (a) to read as follows:


Sec. 1003.109  Notice of proposed determination.

    (a) If the Inspector General proposes a penalty and, when 
applicable, assessment, or proposes to exclude a respondent from 
participation in a 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--
* * * * *
    11. Section 1003.126 would be revised to read as follows:


Sec. 1003.216  Settlement.

    The Inspector General has exclusive authority to settle any issues 
or case, without consent of the ALJ.
    12. Section 1003.128 would be amended by revising paragraph (b) to 
read as follows:


Sec. 1003.128  Collection of penalty and assessment.

* * * * *
    (b) A penalty or assessment imposed under this part may be 
compromised by the Inspector General, and may be recovered in a civil 
action brought in the United States district court for the district 
where the claim was presented, or where the respondent resides.
* * * * *

PART 1005--[AMENDED]

    B. Part 1005 would be amended as follows:
    1. The authority citation for part 1005 would continue to read as 
follows:

    Authority: 42 U.S.C. 405(a), 405(b), 1302, 1320a-7, 1320a-7a and 
1320c-5.

    2. Section 1005.1 would be amended by adding, in alphabetical 
order; a definition for the term Inspector General to read as follows:


Sec. 1005.1  Definitions.

* * * * *
    Inspector General (IG) means the Inspector General of the 
Department of Health and Human Services or his or her designees.
    3. Section 1005.7 would be amended by revising paragraphs (e)(1) 
(e)(2) to read as follows:


Sec. 1005.7  Discovery.

* * * * *
    (e)(1) When a request for production of documents has been 
received, within 15 days the party receiving that request will either 
fully respond to the request, or state that the request is being 
objected to and the reasons for that objection. If objection is made to 
part of an item or category, the part will be specified. Upon receiving 
any objections, the party seeking production may then, within 15 days 
or any other time frame set by the ALJ, file a motion for an order 
compelling discovery. (The party receiving a request for production may 
also file a motion for protective order any time prior to the date the 
production is due.)
    (2) The ALJ may grant a motion for protective order or deny a 
motion for an order compelling discovery if the ALJ finds that the 
discovery sought--
    (i) Is irrelevant;
    (ii) Is unduly costly or burdensome;
    (iii) Will unduly delay the proceeding; or
    (iv) Seeks privileged information
* * * * *
    4. Section 1005.9 would be amended by revising paragraph (b) to 
read as follows:


Sec. 1005.9  Subpoenas for attendance at hearing.

* * * * *
    (b) A subpoena requiring the attendance of an individual in 
accordance with paragraph (a) of this section may also require the 
individual (whether or not the individual is a party) to produce 
evidence authorized under Sec. 1005.7 at or prior to the hearing.
* * * * *
    5. Section 1005.15 would be amended by revising the introductory 
text of paragraph (b) and paragraph (b)(1) to read as follows:


Sec. 1005.15  The hearing and burden of proof.

* * * * *
    (b) With regard to the burden of proof in civil money penalty cases 
under part 1003 of this chapter, in Peer Review Organization exclusion 
cases under part 1004 of this chapter, and in exclusion cases under 
Secs. 1001.701, 1001.901 and 1001.951 of this chapter--
    (1) The respondent or petitioner, as applicable, bears the burden 
of going forward and the burden of persuasion with respect to 
affirmative defenses and any mitigating circumstances; and
* * * * *
    6. Section 1005.21 would be amended by revising paragraph (d) to 
read as follows:


Sec. 1005.21  Appeal to DAB.

* * * * *
    (d) There is no right to appear personally before the DAB or to 
appeal to the DAB any interlocutory ruling by the ALJ, except on the 
timeliness of a filing of the hearing request.
* * * * *

PART 1006--[AMENDED]

    C. Part 1006 would be amended as follows:
    1. The authority citation for part 1006 would continue to read as 
follows:

    Authority: 42 U.S.C. 405(d), 405(e), 1302 and 1320a-7a.

    2. Section 1006.4 would be amended by republishing the introductory 
text of

[[Page 14402]]

paragraph (b) and by revising paragraph (b)(2) to read as follows:


Sec. 1006.4  Procedures for investigational inquiries.

* * * * *
    (b) Investigational inquiries are non-public investigatory 
proceedings. Attendance of non-witnesses is within the discretion of 
the OIG, except that--
* * * * *
    (2) Representatives of the OIG are entitled to attend and ask 
questions.
* * * * *
    Dated: August 21, 1997.
June Gibbs Brown,
Inspector General.

    Approved: December 4, 1997.
Donna E. Shalala,
Secretary.
[FR Doc. 98-7506 Filed 3-24-98; 8:45 am]
BILLING CODE 4150-04-M