[Federal Register Volume 63, Number 54 (Friday, March 20, 1998)]
[Proposed Rules]
[Pages 13590-13608]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7190]



[[Page 13590]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

42 CFR Parts 400 and 421

[HCFA-7020-P]
RIN 0938-AI09


Medicare Program; Medicare Integrity Program, Intermediary and 
Carrier Functions, and Conflict of Interest Requirements

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Proposed rule.

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SUMMARY: This proposed rule would implement section 1893 of the Social 
Security Act (the Act) by establishing the Medicare integrity program 
(MIP) to carry out Medicare program integrity activities that are 
funded from the Medicare Trust Funds. Section 1893 expands our 
contracting authority to allow us to contract with ``eligible 
entities'' to perform Medicare program integrity activities. These 
activities include review of provider and supplier activities, 
including medical, fraud, and utilization review; cost report audits; 
Medicare secondary payer determinations; education of providers, 
suppliers, beneficiaries, and other persons regarding payment integrity 
and benefit quality assurance issues; and developing and updating a 
list of durable medical equipment items that are subject to prior 
authorization. This proposed rule would set forth the definition of 
eligible entities, services to be procured, competitive requirements 
based on Federal acquisition regulations and exceptions (guidelines for 
automatic renewal), procedures for identification, evaluation, and 
resolution of conflicts of interest, and limitations on contractor 
liability.
    In addition, this proposed rule would bring certain sections of the 
Medicare regulations concerning fiscal intermediaries and carriers into 
conformity with the Act. The rule would distinguish between those 
functions that the statute requires be included in agreements with 
intermediaries and those that may be included in the agreements. It 
would also provide that some or all of the listed functions may be 
included in carrier contracts. Currently all these functions are 
mandatory for carrier contracts. These changes would give us the 
flexibility to transfer functions from one intermediary or carrier to 
another or to otherwise limit the functions an intermediary or carrier 
performs if we determine that to do so would result in more effective 
and efficient program administration.

DATES: Comments will be considered if we receive them at the 
appropriate address, as provided below, no later than 5 p.m. on May 19, 
1998.

ADDRESSES: Mail written comments (1 original and 3 copies) to the 
following address: Health Care Financing Administration, Department of 
Health and Human Services, Attention: HCFA-7020-P, P.O. Box 26676, 
Baltimore, MD 21207-0519.
    If you prefer, you may deliver your written comments (1 original 
and 3 copies) to one of the following addresses:

Room 309-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., 
Washington, DC 20201, or
Room C5-09-26, 7500 Security Boulevard, Baltimore, MD 21244-1850.

    Because of staffing and resource limitations, we cannot accept 
comments by facsimile (FAX) transmission. In commenting, please refer 
to file code HCFA-7020-P. Comments received timely will be available 
for public inspection as they are received, generally beginning 
approximately 3 weeks after publication of a document, in Room 309-G of 
the Department's offices at 200 Independence Avenue, SW., Washington, 
DC, on Monday through Friday of each week from 8:30 a.m. to 5 p.m. 
(phone: (202) 690-7890).

FOR FURTHER INFORMATION CONTACT: Brenda Thew (410) 786-4889.

SUPPLEMENTARY INFORMATION:

I. Background

A. Current Medicare Contracting Environment

    The current Medicare contracting authorities have been in place 
since the inception of the Medicare program in 1965. At that time, the 
health insurance and medical communities raised concerns that the 
enactment of Medicare could result in a large Federal presence in the 
provision of health care. In response, under sections 1816(a) and 
1842(a) of the Social Security Act (the Act), Congress provided that 
public or private entities and agencies may participate in the 
administration of the Medicare program under agreements or contracts 
entered into with us.
    These Medicare contractors are known as intermediaries (section 
1816(a) of the Act) and carriers (section 1842(a) of the Act). With 
certain exceptions, intermediaries perform bill processing and benefit 
payment functions for Part A of the program (Hospital Insurance) and 
carriers perform claims processing and benefit payment functions for 
Part B of the program (Supplementary Medical Insurance).
    (For the following discussion, the terms ``provider'' and 
``supplier'' are used as those terms are defined in 42 CFR 400.202. 
That is, a provider is a hospital, rural care primary hospital, skilled 
nursing facility, home health agency, or a hospice that has in effect 
an agreement to participate in Medicare, or a clinic, a rehabilitation 
agency, or a public health agency that has a similar agreement to 
furnish outpatient physical therapy or speech pathology services. 
Supplier is defined as a physician or other practitioner or an entity 
other than a ``provider,'' that furnishes health care services under 
Medicare.)
    Section 1842(a) of the Act authorizes us to contract with private 
entities (carriers) for the purpose of administering the Medicare Part 
B program. Medicare carriers determine payment amounts and make 
payments for services (including items) furnished by physicians and 
other suppliers such as nonphysician practitioners, laboratories, and 
durable medical equipment suppliers. In addition, carriers perform 
other functions required for the efficient and effective administration 
of the Part B program. Section 1842(f) of the Act provides that a 
carrier must be a ``voluntary association, corporation, partnership, or 
other nongovernmental entity which is lawfully engaged in providing, 
paying for, or reimbursing the cost of, health services under group 
insurance policies or contracts, medical or hospital service 
agreements, membership or subscription contracts, or similar group 
arrangements, in consideration of premiums or other periodic charges 
payable to the carrier, including a health benefits plan duly sponsored 
or underwritten by an employee entity.'' No entity may be considered 
for carrier contracts unless it can demonstrate that it meets this 
definition of carrier.
    Section 1842(b) provides us with the discretion to enter into 
carrier contracts without regard to any provision of the law requiring 
competitive bidding. Other provisions of generally applicable Federal 
contract law and regulations, as well as HHS procurement regulations, 
remain in effect for carrier contracts.
    Section 1816(a) of the Act authorizes us to enter into agreements 
with private agencies or entities (intermediaries) for the purpose of 
administering Medicare Part A. These entities are responsible for 
determining the amount of payment due to providers in consideration of 
services provided to beneficiaries and for making

[[Page 13591]]

these payments. We may enter into an agreement with an entity to serve 
as an intermediary if the entity has first been ``nominated'' by a 
group or association of providers to make Medicare payments to it. 
Other portions of section 1816 of the Act provide further details 
concerning the ``nomination process'' and assignment and reassignment 
of providers to intermediaries.
    Our regulations at Sec. 421.100 require that the agreement between 
us and an intermediary specify the functions the intermediary must 
perform. In addition to requiring any items specified by us in the 
agreement that are unique to that intermediary, our regulations require 
that all intermediaries perform activities relating to determining and 
making payments for covered Medicare services, fiscal management, 
provider audits, utilization patterns, resolution of cost report 
disputes, and reconsideration of determinations. Finally, our 
regulations require that all intermediaries furnish information and 
reports, perform certain functions with respect to provider-based home 
health agencies and provider-based hospices, and comply with all 
applicable laws and regulations and with any other terms and conditions 
included in their agreements.
    Similarly, Sec. 421.200 of our regulations, requires that the 
contract between us and a Part B carrier specify the functions the 
carrier must perform. In addition to requiring any items specified by 
us in the contract that are unique to that carrier, our regulations 
require that all Part B carriers perform activities relating to 
determining and making payments (on a cost or charge basis) for covered 
Medicare services, fiscal management, provider audits, utilization 
patterns, and Part B beneficiary hearings. In addition, Sec. 421.200 
requires that all carriers furnish information and reports, maintain 
and make available records, and comply with any other terms and 
conditions included in their contracts.
    It is within the above context that Medicare intermediary and 
carrier contracts are significantly different from standard Federal 
Government contracts.
    Specifically, the Medicare intermediary and carrier contracts are 
normally renewed automatically from year to year, in contrast to the 
typical Government contract that is recompeted at the conclusion of the 
contract term. Congress, in providing for the nomination process under 
section 1816 of the Act, and authorizing the automatic renewal of the 
carrier contracts in section 1842(b)(5) of the Act, contemplated a 
contracting process that would permit us to noncompetitively renew the 
Medicare contracts from year to year.
    For both intermediaries and carriers, Sec. 421.5 states that we 
have the authority not to renew a Part A agreement or a Part B contract 
when it expires. Section 421.126 provides for termination of the 
intermediary agreements in certain circumstances, and, similarly, 
Sec. 421.205 provides for termination of carrier contracts.
    Each year, Congress appropriates funds to support Medicare 
contractor activities. These funds are distributed to the contractors 
through an annual Budget Performance Requirements process, which 
allocates funds by program activity to each of the current 69 Medicare 
contractors. Historically, approximately one-half of the funds have 
been for payment for the processing of claims; one-quarter of the funds 
have been for ``payment safeguard'' activities to fund activities such 
as conducting medical review of claims to determine whether services 
are medically necessary and constitute an appropriate level of care, 
deterring and detecting Medicare fraud, auditing provider cost reports, 
and ensuring that Medicare acts as a secondary payer when a beneficiary 
has primary coverage through other insurance. The remainder of the 
funds have been allocated for beneficiary and provider/supplier 
services and for various productivity investments.

B. The Medicare Integrity Program

    The Health Insurance Portability and Accountability Act of 1996 
(Public Law 104-191) was enacted on August 21, 1996. Section 202 of 
Public Law 104-191 adds a new section 1893 to the Act establishing the 
Medicare integrity program (MIP). This program is funded from the 
Medicare Hospital Insurance Trust Fund for activities related to both 
Part A and Part B of Medicare. Specifically, section 1893 of the Act 
expands our contracting authority to allow us to contract with eligible 
entities to perform Medicare program integrity activities performed 
currently by intermediaries and carriers. These activities include 
medical, fraud, and utilization review; cost report audits; Medicare 
secondary payer determinations; overpayment recovery; education of 
providers, suppliers, beneficiaries, and other persons regarding 
payment integrity and benefit quality assurance issues; and developing 
and updating a list of durable medical equipment items that, under 
section 1834(a)(15) of the Act, are subject to prior authorization.
    Section 1893(d) of the Act requires us to set forth, through 
regulations, procedures for entering into contracts for the performance 
of specific Medicare program integrity activities. These procedures are 
to include the following:
    (1) A process for identifying, evaluating, and resolving 
organizational conflicts of interest that are generally applicable to 
Federal acquisition and procurement.
    (2) Competitive procedures for entering into new contracts under 
section 1893 of the Act, a process for entering into contracts that may 
result in the elimination of responsibilities of an individual 
intermediary or carrier, and other procedures we deem appropriate.
    (3) A process for renewing contracts entered into under section 
1893 of the Act.
    Section 1893(d) also provides that we may enter into these 
contracts without publication of final rules.
    In addition, section 1893(e) of the Act requires us to set forth, 
through regulations, the limitation of a contractor's liability for 
actions taken to carry out a contract.
    Congress established section 1893 of the Act to strengthen our 
ability to deter fraud and abuse in the Medicare program in a number of 
ways. First, it provides a separate and stable long-term funding 
mechanism for MIP activities. Historically, Medicare contractor budgets 
had been subject to wide fluctuations in funding levels from year to 
year. The variations in funding did not have anything to do with the 
underlying requirements for program integrity activities. This 
instability made it difficult for us to invest in innovative strategies 
to control fraud and abuse. Our contractors also found it difficult to 
attract, train, and retain qualified professional staff, including 
auditors and fraud investigators. A dependable funding source allows us 
the flexibility to invest in innovative strategies to combat fraud and 
abuse. It will help us shift emphasis from post-payment recoveries on 
fraudulent claims to prepayment strategies designed to ensure that more 
claims are paid correctly the first time.
    Second, to allow us to more aggressively carry out the MIP 
functions and to require us to use procedures and technologies that 
exceed those currently being used, section 1893 greatly expands our 
contracting authority. Previously, we had a limited pool of entities 
with whom to contract. This limited our ability to maximize efforts to 
effectively carry out the MIP functions. Section 1893 now permits us to 
attract a variety of offerors with potentially new and different skill 
sets and will allow those offerors to propose

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innovative approaches to implement MIP to deter fraud and abuse. By 
using competitive procedures, as established in the FAR, our ability to 
manage the MIP activities is greatly enhanced, and the Government can 
seek to obtain the best value for its contracted services.
    Third, section 1893 requires us to address potential conflicts of 
interest among potential MIP contractors before entering into any 
contracting arrangements with them. By requiring offerors/contractors 
to report situations that may constitute conflicts of interest, we can 
minimize the number of situations where there is either an actual or an 
apparent conflict of interest. This is a concern particularly when 
intermediaries and carriers processing Medicare claims are also private 
health insurance companies.
    From the inception of the Medicare program, intermediary and 
carrier contracts have contained provisions that have precluded 
contractors from using their Medicare contract to benefit their private 
lines of business. These conflicts of interest were rarely a problem in 
the early years of Medicare because these companies did only health 
insurance business within prescribed market areas. In recent years, 
however, Medicare intermediaries and carriers, like most health 
insuring organizations, have expanded their businesses and product 
lines to become large integrated health care delivery systems. Some 
organizations have diversified into corporations with many subsidiaries 
and a variety of arrangements. These range from overlapping ownership 
of other insurers, third party administrators, providers, and managed 
care entities to the marketing of management services and software 
products. This creates a conflict of interest when the contractor 
reviews claims, identifies Medicare secondary payer instances, and 
performs other payment safeguard activities for its own providers and 
suppliers as well as for its provider's and supplier's competitors.
    We have been criticized for the lack of effective mechanisms to 
mitigate these conflicts of interest. Even when we are assured that 
proper mechanisms are in place, the appearance of a conflict remains in 
the eyes of competitors. An even more difficult problem arises with 
respect to program integrity activities. Medicare contractors exercise 
considerable discretion in their audit functions, the use of prepayment 
screens, the conduct of fraud investigations, and referrals to law 
enforcement agencies regarding incidences of fraud and abuse. These 
activities depend upon the ability of the contractor to conduct 
independent reviews, negotiate disputes, and to manipulate data with 
great sophistication to discover situations where providers and 
suppliers are engaged in fraudulent activity. These activities would be 
largely ineffective if contractor-owned providers and suppliers benefit 
from bias or forewarning.
    When a Medicare contractor owns a provider or supplier, it 
necessarily finds itself in a situation in which potential conflicts of 
interest could arise. On the one hand, it has a fiduciary duty to its 
stockholders to use its best efforts to capture market share and to 
maximize profits. On the other hand, it has an obligation to Medicare 
and to the public not to take advantage of its position as a Medicare 
contractor. For example, the Medicare contractor--
     Has access to information about beneficiaries, providers, 
and suppliers that would be enormously useful in marketing and other 
business decisions, including provider/supplier information that is 
considered ``proprietary.''
     As the claims administrator for an area, it has 
extraordinary leverage over providers and suppliers. That leverage 
could be used, implicitly or explicitly, to persuade providers and 
suppliers to join a network or to agree to business arrangements that 
are favorable to the Medicare contractor.
     Has knowledge and experience as a Medicare claims 
administrator that would give it a competitive advantage in knowing how 
to submit claims to avoid payment screens and in having other 
information that is not available to other providers/suppliers that 
could assist in maximizing payments to its own providers/suppliers.
     May also offer other health insurance coverage that is 
primary or supplemental to Medicare. In this situation, there is always 
the temptation to let Medicare pay first, knowing that even if the 
mistaken Medicare payment is later discovered and reimbursed, the 
contractor has received a temporary interest free loan from the 
Government.
    The MIP, however, allows us to separate payment safeguard functions 
from all of the functions now being performed by current intermediaries 
and carriers. This allows current contractors that are performing 
important functions such as beneficiary and provider/supplier services 
well to continue to do so, or possibly to review claims from providers/
suppliers with which they have no financial relationship.
    Conflict of interest situations can also occur when Medicare 
contractors own managed care entities, for example health maintenance 
organizations (HMOs). The mere ownership of an HMO by a Medicare 
contractor would seem to create no conflict of interest concerns since 
the HMO would be dealing directly with the Government. However, in the 
situation in which a physician both works for a contractor-owned HMO 
and maintains a fee-for-service practice, the contractor could give the 
physician a ``bonus'' by doing a less thorough review of his or her 
claims. Additionally, the contractor-owned HMO could use its Medicare 
beneficiary database to perform health screening of beneficiaries, or 
its utilization data, marketing information, etc. for its commercial 
benefit. It could also influence the HMO market by promoting itself as 
the local intermediary or carrier.
    Medicare contractors also provide management services and develop 
software to facilitate the filing of claims and compliance with 
Medicare requirements. Since Medicare contractors have an intimate 
knowledge of Medicare claims systems and administration, they may 
derive an unfair competitive advantage if they were to sell information 
that is not generally available to the public. They may also shift 
development and training costs to Medicare for services they market to 
the public.
    For all these reasons this legislation is providing us an 
opportunity to increase our ability to protect the Medicare program 
from instances of fraud and abuse by establishing procedures for 
identifying, evaluating, and resolving organizational conflicts of 
interest.

II. Provisions of the Proposed Rule

    This regulation is part of our overall contracting strategy, which 
is designed to build on the strengths of the marketplace. We intend to 
implement the MIP incrementally in a manner that will provide a way to 
test alternatives and to transition integrity activities to MIP 
contractors. We are committed to conducting procurements using full and 
open competition that will provide opportunities for a wide range of 
contractors to participate in the program. We will continue to 
encourage new and innovative approaches in the marketplace to protect 
the Medicare Trust Funds.

A. The Medicare Integrity Program

1. Basis, Scope, and Applicability
    In accordance with section 1893 of the Act, this proposed rule 
would amend part 421 by adding a new subpart D entitled, ``Medicare 
Integrity Program Contractors''. This subpart would define the types of 
entities

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eligible to become MIP contractors; identify the program integrity 
functions a MIP contractor may perform; describe procedures for 
awarding and renewing contracts; establish procedures for identifying, 
evaluating, and resolving organizational conflicts of interest; 
prescribe responsibilities; and set forth limitations on MIP contractor 
liability. The provisions of this subpart supplement the Federal 
acquisition regulations set forth at 48 CFR chapter 1 and the 
Department's acquisition regulations at 48 CFR chapter 3. Subpart D 
would be applicable to entities that seek to compete for or receive 
award of a contract under section 1893 of the Act including entities 
that perform functions under this subpart emanating from the processing 
of claims for individuals entitled to benefits as qualified railroad 
retirement beneficiaries. We would set forth the basis, scope, and 
applicability of subpart D in Sec. 421.300.
2. Definition of Eligible Entities
    As discussed earlier, under sections 1816(a) and 1842(a) of the 
Act, public or private entities and agencies (Medicare intermediaries 
and carriers) participate in the administration of the Medicare program 
under agreements or contracts entered into with us (on the Secretary's 
behalf). Basically, the carrier must be a voluntary association, 
corporation, partnership, or other nongovernmental entity lawfully 
engaged in providing or paying for health services under group 
insurance policies or contracts, medical or hospital service 
agreements, membership or subscription contracts, or similar group 
arrangements. In general, the intermediary must be an entity that has 
an agreement with us and has been nominated by a provider to determine 
and make Medicare Part A payments and to perform other related 
functions. Current regulations at Secs. 421.110 and 421.202 specify the 
eligibility requirements current Medicare contractors must meet before 
entering into or renewing an agreement or contract.
    In accordance with section 1893(c) of the Act, proposed 
Sec. 421.302 would provide that an entity is eligible to enter into a 
MIP contract if, in general, it demonstrates the capability to perform 
MIP contractor functions; it agrees to cooperate with the Office of 
Inspector General (OIG), the Attorney General, and other law 
enforcement agencies in the investigation and deterrence of fraud and 
abuse of the Medicare program, including making referrals; it complies 
with the conflict of interest standards in 48 CFR Chapters 1 and 3 and 
is not excluded under the conflict of interest provisions established 
by this rule; and it meets other requirements that we may impose. Also, 
in accordance with the undesignated paragraph following section 
1893(c)(4) of the Act, we would specify that Medicare carriers are 
deemed to be eligible to perform the activity of developing and 
periodically updating a list of durable medical equipment items that 
are subject to prior authorization.
    Note that, in accordance with section 1893(d) of the Act, we may 
continue to contract, for the performance of MIP activities, with 
intermediaries and carriers that had a contract with us on August 21, 
1996 (the effective date of enactment of Public Law 104-191). However, 
in accordance with section 1816(l) or section 1842(c)(6) of the Act 
(both added by Public Law 104-191), they may not duplicate activities 
under both an intermediary agreement or carrier contract and a MIP 
contract, with one excepted activity. The exception permits a carrier 
to develop and update a list of items of durable medical equipment that 
are subject to prior authorization both under the MIP contract and its 
contract under section 1842 of the Act.
3. Definition of MIP Contractor
    We propose to define ``Medicare integrity program contractor,'' at 
Sec. 400.202 (Definitions specific to Medicare), as an entity that has 
a contract with us under section 1893 of the Act to perform program 
integrity activities.
4. Services to be Procured
    A MIP contractor may perform some or all of the MIP activities 
performed currently by intermediaries and carriers. Section 421.304 
would state that the contract between HCFA and a MIP contractor 
specifies the functions the contractor performs. In accordance with 
section 1893(b) of the Act, proposed Sec. 421.304 identifies the 
following as MIP activities.
    a. Medical, utilization, and fraud review. Medical and utilization 
review includes the processes necessary to ensure both the appropriate 
utilization of services and that services meet the professionally 
recognized standards of care. These processes include review of claims, 
medical records, and medical necessity documentation and analysis of 
patterns of utilization to identify inappropriate utilization of 
services. This would include reviewing the activities of providers/
suppliers and other individuals and entities (including health 
maintenance organizations, competitive medical plans, and health care 
prepayment plans). This function results in the identification of 
overpayments, prepayment denials, recommendations for changes in 
national coverage policy, changes in local medical review policies and 
payment screens, referrals for fraud and abuse, and the identification 
of the education needs of beneficiaries, providers, and suppliers.
    Fraud review includes fraud prevention initiatives, responding to 
external customer complaints of alleged fraud, the development of 
strategies to detect potentially fraudulent activities that may result 
in improper Medicare payment, and the identification and development of 
fraud cases for referral to law enforcement. Each solicitation will 
specify when cases should be referred to the OIG. In general, however, 
identified overpayments exceeding a threshold amount set by the OIG, 
recurring acts of improper billing, and substantiated allegations of 
fraudulent activity will be promptly referred to a Regional Office of 
Investigation.
    b. Cost report audits. Providers and managed care plans receiving 
Medicare payments are subject to audit for all payments applicable to 
services furnished to beneficiaries. The audit ensures that proper 
payments are made for covered services, provides verified financial 
information for making a final determination of allowable costs, 
identifies potential instances of fraud and abuse, and ensures the 
completion of special projects.
    This functional area includes the receipt, processing, and 
settlement of cost reports based on reasonable costs, prospective 
payment, or any other basis, and the establishment or adjustment of the 
interim payment rate using cost report or other information.
    c. Medicare secondary payer activities. The Medicare secondary 
payer function is a process developed as a payment safeguard to protect 
the Medicare program against mistaken primary payments. The focus of 
this process is to ensure that the Medicare program pays only to the 
extent required by statute. Entities under a MIP contract that includes 
Medicare secondary payer functions would be responsible for identifying 
Medicare secondary payer situations and/or pursuing recovery of 
mistaken payments from the appropriate entity or individual, depending 
on the specifics of the contract.
    This functional area includes the processes performed to identify 
beneficiaries for whom there is coverage which is primary to Medicare. 
Through these processes, information may be acquired for subsequent use 
in

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beneficiary claims adjudication, recovery, and litigation.
    d. Education. This functional area includes educating 
beneficiaries, providers, suppliers, and other individuals regarding 
payment integrity and benefit quality assurance issues.
    e. Developing prior authorization lists. This functional area 
includes developing and periodically updating a list of durable medical 
equipment items that, in accordance with section 1834(a)(15) of the 
Act, are subject to prior authorization. Section 1834(a)(15) requires 
prior authorization to be performed on the following items of durable 
medical equipment: Items identified as subject to unnecessary 
utilization; items supplied by suppliers that have had a substantial 
number of claims denied under section 1862(a)(1) of the Act as not 
reasonable or necessary or for whom a pattern of overutilization has 
been identified; or a customized item if the beneficiary or supplier 
has requested an advance determination. Prior authorization is a 
determination that an item of durable medical equipment is covered 
prior to when the equipment is delivered to the Medicare beneficiary.
    Application of MIP--It should be noted that the MIP functions are 
not limited to services furnished under fee-for-service payment 
methodologies. MIP functions are applicable to all types of claims. 
They are also applicable to all types of payment systems including, but 
not limited to, managed care and demonstration projects.
5. Competitive Requirements
    We would specify, in Sec. 421.306(a), that MIP contracts will be 
awarded in accordance with 48 CFR chapters 1 and 3, 42 CFR part 421 
subpart D, and all other applicable laws and regulations. Further, in 
accordance with section 1893(d)(2) of the Act, we would specify that 
the procedures set forth in these authorities will be used: (1) When 
entering into new contracts; (2) when entering into contracts that may 
result in the elimination of responsibilities of an individual 
intermediary or carrier; and (3) at any other time we consider 
appropriate.
    In proposed section 421.306(b), we would establish an exception to 
competition which allows a successor in interest to an intermediary 
agreement or carrier contract to be awarded a contract for MIP 
functions without competition, if its predecessor performed program 
integrity functions under the transferred agreement or contract and the 
resources, including personnel, which were involved in performing those 
functions, were transferred to the successor.
    This proposal is made in anticipation that some intermediaries and 
carriers may engage in transactions under which the recognition of a 
successor in interest by means of a novation agreement may be 
appropriate, and the resources involved in the intermediary's or 
carrier's MIP activities are transferred along with its other Medicare-
related resources to the successor in interest. For example, the 
intermediary or carrier may undergo a corporate reorganization under 
which the corporation's Medicare business is transferred entirely to a 
new subsidiary corporation. When all of a contractor's resources or the 
entire portion of the resources involved in performing a contract are 
transferred to a third party, HCFA may recognize the third party as the 
successor in interest to the contract through approval of a novation 
agreement. See 48 CFR 42.12.
    If the intermediary or carrier were performing MIP activities under 
its contract on August 21, 1996, the date of the enactment of the MIP 
legislation, the statute permits HCFA to continue to contract with the 
intermediary or carrier for the performance of those activities without 
using competitive procedures. In the context of a corporate 
reorganization, under which all of the resources involved in performing 
the contract, including those involved in performing MIP activities, 
are transferred to a successor in interest, HCFA may determine that 
breaking out the MIP activities and competing them separately would not 
be in the best interest of the government.
    Inherent in the requirement of section 1893(d) of the Act that the 
Secretary establish competitive procedures to be used when entering 
into contracts for MIP functions is the authority to establish 
exceptions to those procedures. See 48 CFR 6.3. Moreover, intermediary 
agreements and carrier contracts have, by statute, been 
noncompetitively awarded under sections 1816(a) and 1842(b)(1) of the 
Act. Furthermore, those agreements and contracts have in recent years 
prior to the enactment of the MIP legislation included program 
integrity activities, a fact that the Congress acknowledged in section 
1893(d)(2) of the Act. We believe that creating an exception to the use 
of competition for cases in which the same resources, including the 
same personnel, continue to be used by a third party as successor in 
interest to an intermediary agreement or carrier contract is consistent 
with Congress' authorization to forgo competition when the contracting 
entity was carrying out the MIP functions on the date of enactment of 
the MIP legislation. Section 421.306(b) would provide an interim 
solution to permit continuity in the performance of the MIP functions 
until such time as we are prepared to procure MIP functions on the 
basis of full and open competition.
    We would further specify, in Sec. 421.306(c), that an entity must 
meet the eligibility requirements established in proposed Sec. 421.302 
to be eligible to be awarded a MIP contract.
    We would state, in Sec. 421.308(a), that we specify an initial 
contract term in the MIP contract and that contracts may contain 
renewal clauses. Contract renewal provides a mutual benefit to both 
parties. Renewing a contract, when appropriate, results in continuity 
both for us and the contractor and is in the best interest of the 
Medicare program. The benefits are realized through early communication 
of our intention whether to renew a contract, which permits both 
parties to plan for any necessary changes in the event of nonrenewal. 
Furthermore, as a prudent administrator of the Medicare program, we 
must ensure that we have sufficient time to transfer the MIP functions 
should a reassignment of the functions be necessary (either because the 
contractor has given notice of its intent to nonrenew or because we 
have determined that reassignment is in the best interest of the 
Medicare program). Therefore, in Sec. 421.308(a), we would specify that 
we may renew a MIP contract, as we determine appropriate, by giving the 
contractor notice, within timeframes specified in the contract, of our 
intention to do so. (The solicitation document that resulted in the 
contract will contain further details regarding this provision.)
    Based on section 1893(d)(3) of the Act, we would specify, in 
paragraph (b) of Sec. 421.308, that we may renew a MIP contract without 
competition if the contractor continues to meet all the requirements of 
proposed subpart D of part 421, the contractor meets or exceeds all 
performance standards and requirements in the contract, and it is in 
the best interest of the Government.
    We would provide, at Sec. 421.308(c), that, if we do not renew the 
contract, the contract will end in accordance with its terms, and the 
contractor does not have a right to a hearing or judicial review 
regarding the nonrenewal. This is consistent with our longstanding 
policy with regard to intermediary and carrier contracts.
6. Conflict of Interest Rules
    This proposed rule would establish the process for identifying, 
evaluating, and resolving conflicts of interest as required by section 
1893(d)(1) of the Act. The process has been designed to

[[Page 13595]]

ensure that the more diversified business arrangements of potential 
contractors do not inhibit competition between providers/suppliers or 
in other types of businesses related to the insurance industry or have 
the potential for harming Government interests.
    On December 6, 1996, we held an open forum discussion with certain 
organizations and groups that may, or whose members may, be directly 
affected by contracts awarded to perform functions under the MIP. 
During the forum, participants discussed whether certain examples were 
conflicts of interest and how the conflicts, when present, could be 
mitigated. In addition, the conflict of interest situations were made 
available for public review on our Internet home page.
    In general, some of the participants had concerns that a MIP 
contractor could not perform audit or review functions on itself, its 
subsidiaries, its direct competitors, or its private sector clients 
without the presence of a potential conflict of interest. The conflicts 
of interest described could make it impossible for contractor personnel 
to be objective in performing contract work or to provide impartial 
assistance or advice to the Government or could give the contractor an 
unfair competitive advantage.
    Some of the participants recommended that the conflict of interest 
standards we establish restrict a MIP contractor from having an 
ownership interest or contractual relationship with any provider it 
will be auditing or reviewing. Also, the participants generally agreed 
that requirements dictating disclosure of a contractor's financial 
interests would help mitigate conflicts of interest and that each 
contractor's situation should be considered on a case-by-case basis.
    In developing the conflict of interest requirements, we had several 
options. We could refuse to contract with any entity if a conflict of 
interest situation either exists or is perceived to exist, or we could 
choose not to contract with any health-care related entities. We could 
try to develop a list of all potential situations where a conflict of 
interest could possibly arise.
    We rejected all of these options and adopted a ``process 
approach.'' While the process described below employs a greater test 
than generally prescribed in the Federal acquisition regulations for 
conflict of interest situations, we believe that the sensitive nature 
of the work to be performed under the contract, the need to preserve 
the public trust, and the history of fraud and abuse in the Medicare 
program merits these further requirements. The emphasis on process 
requires--
     Disclosure by the offeror or contractor via an 
Organizational Conflicts of Interest Certificate;
     The offeror or contractor to submit a plan to mitigate 
situations that could be considered potential conflicts of interest;
     The offeror to describe a program that it will establish, 
if awarded the contract, to monitor its compliance with any plans 
approved by us to resolve conflicts of interest; and
     The offeror to describe plans to have a compliance audit 
completed by an independent auditor.
    Specifically, in Sec. 421.310(b), we would state the general rule 
that, except as provided in Sec. 421.310(d), we do not enter into a MIP 
contract with an offeror or contractor that we have determined has, or 
has the potential for, an unresolved organizational conflict of 
interest. Paragraph (d) of Sec. 421.310 would provide that we may 
contract with an offeror or contractor that has an unresolved conflict 
if we determine that it is in the best interest of the Government to do 
so. We would define ``organizational conflict of interest,'' at 
Sec. 421.310(a), basing our definition on the definition of that term 
contained in the FAR at 48 CFR 9.501(d). That definition states that 
organizational conflict of interest means ``that because of other 
activities or relationships with other persons, a person is unable or 
potentially unable to render impartial assistance or advice to the 
Government, or the person's objectivity in performing the contract work 
is or might be otherwise impaired, or a person has an unfair 
competitive advantage.'' To clarify how this definition would apply to 
the MIP contract, we would add that, for purposes of the MIP contract, 
the activities and relationships described include those of the offeror 
or contractor itself and other business related to it and those of its 
officers, directors (including medical directors), managers, and 
subcontractors.
    In paragraph (c) of Sec. 421.310, we would state that we determine 
that an offeror or contractor has an organizational conflict of 
interest, or a potential for the conflict exists, if the offeror or 
contractor either is, or has a present, or known future, direct or 
indirect financial relationship with, an entity we describe in 
Sec. 421.310(c)(3), which is discussed later in this preamble. In 
paragraph (a) of Sec. 421.310, we would define ``financial 
relationship'' as (1) a direct or indirect ownership or investment 
interest (including an option or nonvested interest) in any entity that 
exists through equity, debt, or other means and includes any indirect 
ownership or investment interest no matter how many levels removed from 
a direct interest, or (2) a compensation arrangement with an entity. 
This definition is similar to the definition at Sec. 411.351, which is 
used for purposes of the provision which generally prohibits physicians 
from making referrals for Medicare services to entities with which the 
physician or a member of the physician's immediate family has a 
financial relationship. The definition at Sec. 411.351 was based on 
section 1877(a)(2) of the Act as it read before January 1, 1995. To 
reflect the current reading of section 1877(a)(2), we have added, in 
our proposed definition, that an indirect interest can exist through 
multiple levels.
    In paragraph (c)(2) of Sec. 421.310, we would specify that a 
financial relationship may exist either through an offeror's or 
contractor's parent companies, subsidiaries, affiliates, 
subcontractors, or current clients. We would also specify that a 
financial relationship may exist from the activities and relationships 
of the officers, directors (including medical directors), or managers 
of the offeror or contractor and may be either direct or indirect. We 
would define an indirect financial relationship as an ownership or 
investment interest that is held in the name of another but provides 
benefits to the officer, director, or manager.
    In Sec. 421.310(c)(3), we would provide that an offeror or 
contractor has a conflict of interest, or a potential conflict of 
interest, if it is, or has a present or known future financial 
relationship with, an entity that--
     Provides, insures, or pays for health benefits, with the 
exception of health plans provided as the entity's employee fringe 
benefit;
     Conducts audits of health benefit payments or cost 
reports;
     Conducts statistical analysis of health benefit 
utilization;
     Would review or does review, under the contract, Medicare 
services furnished by a provider or supplier that is a direct 
competitor of the offeror or contractor;
     Prepared work or is under contract to prepare work that 
would be reviewed under the MIP contract; or
     Is affiliated, as that term is explained in 48 CFR 19.101, 
with a provider or supplier to be reviewed under the MIP contract. 
(Section 19.101 of 48 CFR states that--
    * * * business concerns are affiliates of each other if, directly 
or indirectly, either one controls or has the power to control the 
other, or another concern controls or has the power to control

[[Page 13596]]

both. In determining whether affiliation exists, consideration is given 
to all appropriate factors including common ownership, common 
management, and contractual relationships; provided, that restraints 
imposed by a franchise agreement are not considered in determining 
whether the franchisor controls or has the power to control the 
franchisee, if the franchisee has the right to profit from its effort, 
commensurate with ownership, and bears the risk of loss of failure. Any 
business entity may be found to be an affiliate, whether or not it is 
organized for profit or located inside the United States.

Section 19.101 explains that control may exist through stock ownership, 
stock options, convertible debentures, voting trusts, common 
management, and contractual relationships.)
    We would be interested in receiving comments as to how we might 
better identify those situations that create a conflict of interest. 
For example, we had originally considered including all entities that 
provide, insure, or pay for health benefits. We have, however, 
identified the situation in which an offeror or contractor provides 
health benefits as an employee fringe benefit as being one where the 
likelihood of a conflict would not exist. We would be interested in 
receiving comments as to whether it would be appropriate to create 
other exceptions.
    In Sec. 421.310(c)(4), we would specify that we may determine that 
an offeror or contractor has an organizational conflict of interest, or 
the potential for one exists, based on apparent organizational 
conflicts of interest or on other contracts and grants with the Federal 
Government. We would provide that an apparent conflict of interest 
exists if a prudent business person has cause to believe that the 
offeror or contractor would have a conflict of interest in performing 
the requirements of the MIP contract. We would further provide that no 
inappropriate action by the offeror or contractor is necessary for an 
apparent conflict to exist. We believe it is necessary to consider the 
offeror's or contractor's other contracts and grants with the Federal 
Government to determine whether the offeror's or contractor's financial 
dependence upon the Government could influence the likelihood that it 
would provide unbiased opinions, conclusions, and work products.
    In paragraph (e) of Sec. 421.310, we would specify that an offeror 
or contractor is responsible for determining whether an organizational 
conflict of interest exists in any of its proposed or actual 
subcontractors and consultants at any tier. We also would specify that 
the offeror or contractor is responsible for ensuring that its 
subcontractors and consultants have mitigated any conflicts or 
potential conflicts.
    In paragraph (f) of Sec. 421.310, we would state that we consider 
that a conflict of interest has occurred if, during the term of the 
contract, the contractor received any fee, compensation, gift, payment 
of expenses, or any other thing of value from an entity that is 
reviewed, audited, investigated, or contacted during the normal course 
of performing activities under the MIP contract. We have considered 
creating an exception for those compensations, fees, gifts, and other 
things of value that are in an amount that would not affect a 
contractor's impartiality or objectivity in carrying out its 
responsibilities under the MIP contract. We would be interested in 
receiving comments suggesting how we might determine an appropriate 
dollar amount for such an exception.
    We would also specify in paragraph (f) of Sec. 421.310 that a 
conflict of interest has occurred during the term of the contract if we 
determine that the contractor's activities are creating a conflict. In 
addition, we would specify that, if we determine that a conflict of 
interest exists, among other actions, we may, as we deem appropriate--
     Not renew the contract for an additional term;
     Modify the contract; or
     Terminate the contract.
    In Sec. 421.312(a), we would specify that offerors and MIP 
contractors must submit an Organizational Conflicts of Interest 
Certificate that contains the following information unless it has 
otherwise been provided in the proposal, in which case it must be 
referenced:
     A description of all business or contractual relationships 
or activities that may be viewed by a prudent business person as a 
conflict of interest.
     A description of the methods the offeror or contractor 
will apply to mitigate any situation listed in the Certificate that 
could be identified as a conflict of interest.
     A description of the offeror's or contractor's program to 
monitor its compliance and the compliance of its proposed and actual 
subcontractors and consultants with the conflict of interest 
requirements as identified in the relevant solicitation.
     A description of the offeror's or contractor's plans to 
contract for a compliance audit to be conducted by an independent 
auditor would be required for all MIP contractor procurements.
     An affirmation, using language that we may prescribe, 
signed by an official authorized to bind the offeror or contractor, 
that the offeror or contractor understands that we may consider any 
deception or omission in the Certificate grounds for nonconsideration 
for contract award in the procurement process, termination of the 
contract, or other contract action.
     Corporate and organizational structure.
     Financial interests in other entities, including the 
following:
    + Percentage of ownership in any other entity.
    + Income generated from other sources.
    + A list of current or known future contracts or arrangements, 
regardless of size, with any insurance organization; subcontractor of 
an insurance organization; or providers or suppliers furnishing 
services for which payment may be made under the Medicare program. This 
information is to include the dollar amount of the contracts or 
arrangements, the type of work performed, and the period of 
performance.
     Information regarding potential conflicts of interest and 
financial information regarding certain contracts for all of the 
offeror's or contractor's officers, directors (including medical 
directors), and managers who would be or are involved in the 
performance of the MIP contract. We may also require officers, 
directors (including medical directors) and managers to provide 
financial information regarding their ownership in other entities and 
their income from other sources.
    We would also specify that the solicitation may require more 
detailed information than identified above. Our proposed provisions do 
not describe all of the information that may be required, or the level 
of detail that would be required, because we wish to have the 
flexibility to tailor the disclosure requirements to each specific 
procurement.
    With regard to ownership, we invite public comments to establish 
the level of financial interest that could be considered a material 
interest in different situations. While we would not establish this 
level in the final rule, it may be included in solicitations for 
specific contract situations.
    We intend to reduce the reporting and recordkeeping requirements as 
much as is feasible, while taking into consideration our need to have 
assurance that a conflict of interest does not exist in the MIP 
contractors.

[[Page 13597]]

    By providing documentation of potential conflicts of interest and 
how the offeror plans to mitigate those conflicts in the Certificate, 
the offeror gives us enough information to determine on a case-by-case 
basis if conflicts of interest have been adequately mitigated or should 
preclude award of MIP contracts. The burden associated with providing 
the requested information is justified by the large expansion of 
competition the process allows.
    We propose, in Sec. 421.312(b) that the Organizational Conflicts of 
Interest Certificate be disclosed--
     With the offeror's proposal;
     When the HCFA Contracting Officer requests a revision in 
the Certificate;
     As part of a compliance audit by the independent auditor;
     Forty-five days before any change in the information 
submitted on the Certificate. In this case, only changed information 
must be submitted.
    We would state, in Sec. 421.312(c), that we evaluate organizational 
conflicts of interest and potential conflicts using the information 
provided in the Certificate.
    Because potential offerors may have questions about whether 
information submitted in response to a solicitation, including the 
Organizational Conflicts of Interest Certificate, may be redisclosed 
under the Freedom of Information Act, we provide the following 
information.
    To the extent that a proposal containing the Organizational 
Conflicts of Interest Certificate is submitted to us as a requirement 
of a competitive solicitation under 41 U.S.C. Chapter 4, Subchapter IV, 
we will withhold the proposal when requested under the Freedom of 
Information Act. This withholding is based upon 41 U.S.C. Sec. 253b(m). 
However, there is one exception to this policy. It involves any 
proposal that is set forth or incorporated by reference in the contract 
awarded to the proposing bidder. Such a proposal may not receive 
categorical protection. Rather, we will withhold, under 5 U.S.C. 
552(b)(4), information within the proposal (and Certificate) that is 
required to be submitted that constitutes trade secrets or commercial 
or financial information that is privileged or confidential provided 
the criteria established by National Parks & Conservation Association 
v. Morton, 498 F.2d 765 (D.C. Cir 1974), as applicable, are met. For 
any such proposal, we will follow pre-disclosure notification 
procedures set forth at 45 CFR 5.65(d). In addition, we will protect 
under 5 U.S.C. 552(b)(6) any information within the Certificate that is 
of a highly sensitive personal nature.
    Any proposal containing the Organizational Conflicts of Interest 
Certificate submitted to us under an authority other than 41 U.S.C. 
Chapter 4, Subchapter IV, and any Certificate or information submitted 
independent of a proposal will be evaluated solely on the criteria 
established by National Parks & Conservation Association v. Morton and 
other appropriate authorities to determine if the proposal or 
Certificate in whole or in part contains trade secrets or commercial or 
financial information that is privileged or confidential and protected 
from disclosure under 5 U.S.C. 552(b)(4). Again, for any such proposal 
or Certificate, we will follow pre-disclosure notification procedures 
set forth at 45 CFR 5.65(d) and will also invoke 5 U.S.C. 552(b)(6) to 
protect information that is of a highly sensitive personal nature.
    We already protect information we receive in the contracting 
process. However, to allay any fears potential offerors might have 
about disclosure, we propose to provide, at Sec. 421.312(d), that we 
protect disclosed proprietary information as allowed under the Freedom 
of Information Act and that we require signed statements from our 
personnel with access to proprietary information that prohibit personal 
use during the procurement process and term of the contract.
    In proposed Sec. 421.314, we describe how conflicts of interest are 
resolved. We specify that we establish a Conflicts of Interest Review 
Board to resolve conflicts of interest and that we determine when the 
Board is convened. We would define resolution of an organizational 
conflict of interest as a determination that----
     The conflict has been mitigated;
     The conflict precludes award of a contract to the offeror;
     The conflict requires that we modify an existing contract;
     The conflict requires that we terminate an existing 
contract; or
     It is in the best interest of the Government to contract 
with the offeror or contractor even though the conflict exists.
    Examples of methods an offeror or contractor may use to mitigate 
organizational conflicts of interest, including those created as a 
result of the financial relationships of individuals within the 
organization are shown below. These examples are not intended to be an 
exhaustive list of all the possible methods to mitigate conflicts of 
interest nor are we obligated to approve a mitigation method that uses 
one or more of these examples. An offeror's or contractor's method of 
mitigating conflicts of interest would be evaluated on a case-by-case 
basis.
     Divestiture of or reduction in the amount of the financial 
relationship the organization has in another organization to a level 
acceptable to us and appropriate for the situation.
     If shared responsibilities create the conflict, a plan, 
included in the Organizational Conflicts of Interest Certificate and 
approved by us, to separate lines of business and management or 
critical staff from work on the MIP contract.
     If the conflict exists because of the amount of financial 
dependence upon the Federal Government, negotiating a phasing out of 
other contracts or grants that continue in effect at the start of the 
MIP contract.
     If the conflict exists because of the financial 
relationships of individuals within the organization, divestiture of 
the relationships by the individual involved.
     If the conflict exists because of an individual's indirect 
interest, divestiture of the interest to levels acceptable to us or 
removal of the individual from the work under the MIP contract.
    In the procurement process, we determine which proposals are in a 
``competitive range.'' The competitive range is based on cost or price 
and other factors that are stated in the solicitation and includes all 
proposals that have a reasonable chance for contract award. Using the 
process proposed in this regulation, offerors will not be excluded from 
the competitive range based solely on conflicts of interest. If we 
determine that an offeror in the competitive range has a conflict of 
interest that is not adequately mitigated, we would inform the offeror 
of the deficiency and give it an opportunity to submit a revised 
Certificate. At any time during the procurement process, we may convene 
the Conflict of Interest Review Board to evaluate and resolve conflicts 
of interest.
    By providing a better process for the identification, evaluation, 
and resolution of conflicts of interest, we not only protect Government 
interests but help ensure that contractors will not restrict 
competition in their service areas by using their position as a MIP 
contractor.
7. Limitation on MIP Contractor Liability and Payment of Legal Expenses
    As discussed earlier, contractors who perform activities under the 
MIP contract will be reviewing activities of providers and suppliers 
that provide services to Medicare beneficiaries. Their contracts will 
authorize them to evaluate the performance of providers,

[[Page 13598]]

suppliers, individuals, and other entities that may subsequently 
challenge their decisions. To reduce or eliminate a MIP contractor's 
exposure to possible legal action from those it reviews, section 
1893(e) of the Act requires that we, by regulation, limit a MIP 
contractor's liability for actions taken in carrying out its contract. 
We must establish, to the extent we find appropriate, standards and 
other substantive and procedural provisions that are the same as, or 
comparable to, those contained in section 1157 of the Act.
    Section 1157 of the Act limits liability and provides for the 
payment of legal expenses of an Utilization and Quality Control Peer 
Review Organization (PRO) that contracts to carry out functions under 
section 1154(e) of the Act. Specifically, section 1157 provides that 
PROs, their employees, fiduciaries, and anyone who furnishes 
professional services to a PRO are protected from civil and criminal 
liability in performing their duties under the Act or their contract, 
provided these duties are performed with due care. Following the 
mandate of section 1893(e), this proposed rule, at Sec. 421.316(a), 
would protect MIP contractors from liability in the performance of 
their contracts provided they carry out their contractual duties with 
care.
    In accordance with section 1893(e), we propose to employ the same 
standards for the payment of legal expenses as are contained in section 
1157(d) of the Act. Therefore, Sec. 421.316(b) will provide that we 
will make payment to MIP contractors, their members, employees, and 
anyone who provides them legal counsel or services for expenses 
incurred in the defense of any legal action related to the performance 
of a MIP contract. We propose that the payment be limited to the 
reasonable amount of expenses incurred, as determined by us, provided 
funds are available and that the payment is otherwise allowable under 
the terms of the contract.
    In drafting Sec. 421.316(2), we considered employing a standard for 
the limitation of liability other than the due care standard. For 
example, we considered whether it would be appropriate to provide that 
a contractor would not be criminally or civilly liable by reason of the 
performance of any duty, function, or activity under its contract 
provided the contractor was not grossly negligent in that performance. 
However, section 1893(e) requires that we employ the same or comparable 
standards and provisions as are contained in section 1157 of the Act. 
We do not believe that it would be appropriate to expand the scope of 
immunity to a standard of gross negligence, as it would not be a 
comparable standard to that set forth in section 1157(b) of the Act.
    We also considered indemnifying MIP contractors employing 
provisions similar to those contained in the current Medicare 
intermediary agreements and carrier contracts. Generally, 
intermediaries and carriers are indemnified for any liability arising 
from the performance of contract functions provided the intermediary's 
or carrier's conduct was not grossly negligent, fraudulent, or 
criminal. However, we may indemnify a MIP contractor only to the extent 
we have specific statutory authority to do so. Section 1893(e) does not 
provide that authority. In addition, Sec. 421.316(a) provides for 
immunity from liability in connection with the performance of a MIP 
contract provided the contractor exercised due care. Indemnification is 
not necessary since the MIP contractors will have immunity from 
liability under Sec. 421.316(a).

B. Intermediary and Carrier Functions

    Section 1816(a) of the Act, which provides that providers may 
nominate an intermediary, requires only that nominated intermediaries 
perform the functions of determining payment amounts and making 
payment, and section 1842(a) of the Act requires only that carriers 
perform ``some or all'' of the functions cited in that section. Our 
requirements at Secs. 421.100 and 421.200 concerning functions to be 
included in intermediary agreements and carrier contracts far exceed 
those of the statute. Therefore, on February 22, 1994, we published a 
proposed rule (59 FR 8446) that would distinguish between those 
functions that the statute requires be included in agreements with 
intermediaries and those functions, which although not required to be 
performed by intermediaries, may be included in intermediary agreements 
at our discretion. We also proposed that any functions included in 
carrier contracts would be included at our discretion. In addition, we 
proposed to add payment on a fee schedule basis as a new function that 
may be performed by carriers.
    In light of the expansion of our contracting authority by section 
1893 of the Act to allow us to contract with eligible entities to 
perform Medicare program integrity activities performed currently by 
intermediaries and carriers, we have decided not to finalize the 
February 1994 proposed rule. Instead, in this proposed rule we are 
setting forth a new proposal to bring those sections of the regulations 
that concern the functions Medicare intermediaries and carriers perform 
into conformity with the provisions of sections 1816(a), 1842(a), and 
1893(b) of the Act.
    As noted in section I.A. of this preamble, our regulations at 
Sec. 421.100 specify a list of functions that must, at a minimum, be 
included in all intermediary agreements. Similarly, Sec. 421.200 
specifies a list of functions that must, at a minimum, be included in 
all carrier contracts. These requirements far exceed those of the 
statute.
    Section 1816(a) of the Act requires only that an intermediary 
agreement provide for determination of the amount of payments to be 
made to providers and for the making of the payments. Section 1816(a) 
permits, but does not require, an intermediary agreement to include 
provisions for the intermediary to provide consultative services to 
providers to enable them to establish and maintain fiscal records or to 
otherwise qualify as providers. It also provides that, for those 
providers to which the intermediary makes payments, the intermediary 
may serve as a channel of communications between us and the providers, 
may make audits of the records of the providers, and may perform other 
functions as are necessary.
    We believe that section 1816(a) mandates only that an intermediary 
make payment determinations and make payments and that, because of the 
nomination provision of section 1816(a), these functions must remain 
with intermediaries. We believe that section 1816(a) does not require 
that the other functions set forth at Sec. 421.100 (c) through (i) be 
included in all intermediary agreements. Further, section 1893 of the 
Act permits the performance of functions related to Medicare program 
integrity by other entities. Thus, Sec. 421.100 needs to be revised to 
be consistent with section 1893 and the implementing regulation. We 
also believe that mandatory inclusion of all functions in all 
agreements limits our ability to efficiently and effectively administer 
the Medicare program. For example, if an otherwise competent 
intermediary performs a single function poorly, it would be efficient 
and effective to have that function transferred to another contractor 
that could carry it out in a satisfactory manner. The alternative is to 
not renew or to terminate the agreement of that intermediary and to 
transfer all functions to a new contractor that may not have had an 
ongoing relationship with the local provider community.

[[Page 13599]]

    Therefore, we would revise Sec. 421.100 to specify that an 
agreement between us and an intermediary specifies the functions to be 
performed by the intermediary and that these must include determining 
the amount of payments to be made to providers for covered services 
furnished to Medicare beneficiaries and making the payments and may 
include any or all of the following functions:
     Any or all of the MIP functions identified in proposed 
Sec. 421.304, provided that they are continuing to be performed under 
an agreement entered into under section 1816 of the Act that was in 
effect on August 21, 1996, and they do not duplicate work being 
performed under a MIP contract.
     Undertaking to adjust overpayments and underpayments and 
to recover overpayments when it has been determined that an overpayment 
has been made.
     Furnishing to us timely information and reports that we 
request in order to carry out our responsibilities in the 
administration of the Medicare program.
     Establishing and maintaining procedures that we approve 
for the review and reconsideration of payment determinations.
     Maintaining records and making available to us the records 
necessary for verification of payments and for other related purposes.
     Upon inquiry, assisting individuals with respect to 
matters pertaining to an intermediary contract.
     Serving as a channel of communication to and from us of 
information, instructions, and other material as necessary for the 
effective and efficient performance of an intermediary contract.
     Undertaking other functions as mutually agreed to by us 
and the intermediary.
    In Sec. 421.100(c), we would specify that, with respect to the 
responsibility for services to a provider-based HHA or a provider-based 
hospice, when different intermediaries serve the HHA or hospice and its 
parent provider under Sec. 421.117, the designated regional 
intermediary determines the amount of payment and makes payments to the 
HHA or hospice. The intermediary and/or MIP contractor serving the 
parent provider performs fiscal functions, including audits and 
settlement of the Medicare cost reports and the HHA and hospice 
supplement worksheets.
    Section 1842(a), which pertains to carrier contracts, requires that 
the contract provide for some or all of the functions listed in that 
paragraph, but does not specify any functions that must be included in 
a carrier contract. As in the case of intermediary agreements, our 
experience has been that mandatory inclusion of a long list of 
functions in all contracts restricts our ability to administer the 
carrier contracts with optimum efficiency and effectiveness. We believe 
that the requirements of the regulations for both intermediaries and 
carriers should be brought into conformity with the statutory 
requirements. Therefore, we would revise existing Sec. 421.200, 
``Carrier functions,'' to make it consistent with section 1893 of the 
Act and the implementing regulations. We would provide that a contract 
between HCFA and a carrier specifies the functions to be performed by 
the carrier, which may include the following:
     Any or all of the MIP functions described in Sec. 421.304 
if the following conditions are met: (1) The carrier is continuing 
those functions under a contract entered into under section 1842 of the 
Act that was in effect on August 21, 1996; and (2) they do not 
duplicate work being performed under a MIP contract, except that the 
function related to developing and maintaining a list of durable 
medical equipment may be performed under both a carrier contract and a 
MIP contract.
     Receiving, disbursing, and accounting for funds in making 
payments for services furnished to eligible individuals within the 
jurisdiction of the carrier.
     Determining the amount of payment for services furnished 
to an eligible individual.
     Undertaking to adjust incorrect payments and recover 
overpayments when it has been determined that an overpayment has been 
made.
     Furnishing to us timely information and reports that we 
request in order to carry out our responsibilities in the 
administration of the Medicare program.
     Maintaining records and making available to us the records 
necessary for verification of payments and for other related purposes.
     Establishing and maintaining procedures under which an 
individual enrolled under Part B will be granted an opportunity for a 
fair hearing.
     Upon inquiry, assisting individuals with matters 
pertaining to a carrier contract.
     Serving as a channel of communication to and from us of 
information, instructions, and other material as necessary for the 
effective and efficient performance of a carrier contract.
     Undertaking other functions as mutually agreed to by us 
and the carrier.

C. Technical and Editorial Changes

    Because we propose to add a new subpart D to part 421 that would 
apply to MIP contractors, we propose to change the title of part 421 
from ``Intermediaries and Carriers'' to ``Medicare Contracting''. We 
also propose to revise Sec. 421.1, which sets forth the basis, scope, 
and applicability of part 421. We would revise this section to add 
section 1893 of the Act to the list of provisions upon which the part 
is based. We would also make editorial and other changes (such as 
reorganizing the contents of the section and providing headings) that 
improve the readability of the section without affecting its substance.
    In addition, numerous sections of our regulations specifically 
refer to an action being taken by an intermediary or a carrier. If the 
action being described may now be performed by a MIP contractor that is 
not an intermediary or a carrier, we would revise those sections to 
indicate that this is the case. As an example, Sec. 424.11, which sets 
forth the responsibilities of a provider, specifies, in paragraph 
(a)(2), that the provider must keep certification and recertification 
statements on file for verification by the intermediary. A MIP 
contractor now may also perform the verification. Therefore, we would 
revise Sec. 424.11(a)(2) to specify that the provider must keep 
certification and recertification statements on file for verification 
by the intermediary or MIP contractor. Because our regulations are 
continuously being revised and sections redesignated, we have not 
identified all such sections that will have technical changes in this 
rule, but we will do so in the final rule. If we determine that 
substantive changes to our regulations are necessary, we will make 
those changes through separate rulemaking.

III. Response to Comments

    Because of the large number of items of correspondence we normally 
receive on Federal Register documents published for comment, we are not 
able to acknowledge or respond to them individually. We will consider 
all comments we receive by the date and time specified in the DATES 
section of this preamble, and, if we proceed with a subsequent 
document, we will respond to the comments in the preamble to that 
document.

IV. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 60-day notice in the Federal Register and solicit public 
comment before a

[[Page 13600]]

collection of information requirement is submitted to the Office of 
Management and Budget (OMB) for review and approval. In order to fairly 
evaluate whether an information collection should be approved by OMB, 
section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires 
that we solicit comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    We are soliciting public comment on each of the issues for sections 
Secs. 421.310 and 421.312 of this document, which contain information 
collection requirements.

Section 421.310  Conflict of Interest Identification

    Section 421.310(e) requires offerors to determine if an 
organizational conflict of interest exists in any of its proposed or 
actual subcontractors at any tier and to ensure that the subcontractors 
have mitigated any conflict of interest or potential conflict of 
interest. As discussed below, the information collection requirements 
for Sec. 421.312 also require an offeror to list in an Organizational 
Conflicts of Interest Certificate situations that could be identified 
as conflicts of interest and to describe methods it would apply to 
mitigate those situations. Based on our best estimate, we believe that 
the requirement will impose a burden of 80 hours on each offeror with 
respect to information it provides for its own organization. It is 
assumed that offerors will impose the same or similar disclosure 
requirements on their proposed or actual subcontractors as imposed by 
us on offerors, with the understanding that we would not expect them to 
require that independent auditors perform compliance audits on 
subcontractors. Based on this assumption, an offeror's burden with 
respect to its subcontractors is estimated to be one-half the burden 
imposed on an offeror with respect to its own organization.
    We expect 15 offerors for each type of MIP contract. We estimate 
that the requirement of this provision will impose a burden of 40 hours 
per subcontractor on each offeror to identify and mitigate any 
organizational conflicts of interest for its subcontractors at any 
tier. We believe that, on average, each offeror will need to evaluate 
three subcontractors. The total burden referenced in Sec. 421.310(e) 
with respect to an offeror's subcontractors is 1,800 burden hours.

Section 421.312  Conflict of Interest Evaluation

    Section 421.312 requires offerors that wish to be eligible for the 
award of a contract under this subpart and MIP contractors to submit an 
Organizational Conflicts of Interest Certificate for pre-and post-award 
purposes.
    Based on comments provided by the public on possible methods we 
could use to identify, evaluate, and resolve potential conflicts of 
interest, we found that only by imposing the information collection 
requirements referenced in this section could competition remain open 
to all interested parties regardless of their current lines of business 
and, at the same time provide us with enough information to determine 
on a case-by-case basis if conflicts of interest have been properly 
identified and adequately mitigated. Only by imposing these information 
collection requirements can we determine whether an offeror should be 
awarded a MIP contract.
    Below is a summary of the proposed Organizational Conflict of 
Interest Certificate disclosure requirements and related burden 
required with the offeror's proposal. The items of information 
described below will be required for all MIP contractor procurements, 
unless the information is otherwise provided in the proposal, in which 
case it must be referenced. The last item identifies some information 
that officers, directors, and managers will be required to provide in 
all MIP procurements and some information that they may be required to 
provide in a MIP procurement.
     A description of all business or contractual relationships 
or activities that a prudent business person may view as a conflict of 
interest. 
    We have received comments from the insurance industry and 
affiliated sources that some situations that we may not readily 
identify as conflicts nonetheless appear to create conflicts of 
interest. If a prudent business person could believe a conflict of 
interest exists in a situation, the entity is required to report the 
situation even if we have not created a ``classification'' for the 
situation. We would use this information to evaluate the situation and 
to determine if it is adequately mitigated or requires no mitigation. 
In addition, we would use this information to adapt to changing 
environments and to modify the conflict of interest requirements.
     A description of the methods the offeror/contractor will 
apply to mitigate any situations listed in the Certification that could 
be identified as conflicts of interest. 
    We would use the description of the methods the offeror/contractor 
will apply to mitigate any situations listed in the Certification that 
could be identified as conflicts of interest to determine if conflicts 
would be neutralized effectively by the methods described. Generally, 
we consider a conflict of interest to exist when a contractor's ability 
to make impartial decisions or perform its work under its contract 
objectively has been or may be compromised. The offeror/contractor 
could propose to mitigate a conflict of interest by using methods such 
as divestiture or reduction of a conflicting financial interest, 
reassignment of work responsibilities to exclude individuals with 
conflicting interests from performing work under the contract, or 
separating lines of business. We would assess the effectiveness of the 
mitigation method using the information disclosed regarding an 
offeror's/contractor's organizational structure, financial interests, 
or other relationships as may be required in a solicitation as 
discussed below.
     A description of the offeror's/contractor's program to 
monitor its compliance and the compliance of its proposed and actual 
subcontractors with the conflict of interest requirements as identified 
in the relevant solicitation. 
    We would evaluate the proposed compliance program to determine if 
the program would enable an offeror/contractor to effectively monitor 
its compliance and its subcontractors' compliance with conflict of 
interest requirements specific to the contract. This requirement is 
integrally connected with an entity's description of its method to 
mitigate conflicts. Once conflicts are mitigated at the inception of a 
contract, an entity must be vigilant to ensure that the methods are 
followed and that new conflicts of interest that arise during the term 
of the contract are identified and mitigated. We would use the 
compliance program to ensure we award contracts only to offerors that 
will follow proposed methods for mitigation of conflicts and that 
offerors establish an administrative mechanism for disclosure of 
changing situations that may require contract modifications.
     An affirmation, using language that we may prescribe, that 
the offeror/contractor understands that we may consider any deception 
or omission in the Certificate grounds for nonconsideration in the 
procurement

[[Page 13601]]

process, termination of the contract, or other contract action. 
    The affirmation places a higher degree of accountability on the 
entity for the accuracy of the information disclosed than would 
otherwise be afforded. By signing the affirmation, the offeror/
contractor will be put on notice of the consequences for any false 
statement or omission of information regarding conflicts of interest. 
The person signing the affirmation will be put on notice of the 
offeror's/contractor's responsibility for ensuring the veracity of the 
information disclosed. We would consider the provision of false or 
deceptive information in the affirmation as possible grounds for 
elimination of an offeror from consideration in the procurement process 
or taking other appropriate contract or legal action.
     A description of the offeror's/contractor's plans to 
contract with an independent auditor to conduct a compliance audit. 
    We would use this information to ensure that the offeror has an 
arrangement with an independent source that will verify compliance with 
conflict of interest requirements.
     Corporate and organizational structure.
    We would require this information to determine if legal entities 
are connected through partnerships, joint ventures, or other legal 
arrangements. We would assess the types of relationships, evaluate an 
offeror's/contractor's mitigation methods, and determine if the 
conflicts of interest based on an offeror's/contractor's relationships 
have been resolved as part of the procurement process. This information 
would also be used during the term of the contract to evaluate the 
mitigation of conflicts when structures change.
     Financial interests in other entities, including the 
following: 
    + Percentage of ownership in any other entity. 
    We would use the percentage of ownership interest and the dollar 
value of financial interests to evaluate reported conflicts of interest 
and the adequacy of an offeror's/contractor's mitigation methods. Both 
these measures were suggested by the participants in the 1996 open 
forum discussion as appropriate considerations in evaluating conflicts 
of interest. We would perform the evaluation on a case-by-case basis.
     Income generated from other sources.
    We would use this information to determine if the offeror/
contractor could be unduly influenced by other financial relationships 
it may have with possible customers, competitors, or other parties 
interested in influencing the performance of the MIP contractor. Income 
can be generated in a variety of ways, for example, as fees, salaries, 
reimbursements, or stock options. This information would enable us to 
evaluate the adequacy of an offeror's/contractor's proposed mitigation 
methods for conflicts of interest that arise from financial dependence 
on other entities.
     A list of current or known future contracts or 
arrangements, regardless of size, with any insurance organization; 
subcontractor of an insurance organization; or provider or supplier 
furnishing services for which payment may be made under the Medicare 
program. This information is to include the dollar amount of the 
contracts or arrangements, the type of work performed, and the period 
of performance. 
    We would use this information to evaluate an offeror's/contractor's 
conflicts that are based on contractual arrangements and to assess the 
adequacy of its mitigation method. The offeror/contractor would be 
required to disclose future contracts so that we can assess whether 
mitigation methods address conflicts that will develop during the 
procurement process or during the term of the contract.
     Information regarding potential conflicts of interest and 
financial information regarding certain contracts for all of the 
offeror's/contractor's officers, directors (including medical 
directors), and managers who would be or are involved in the 
performance of the MIP contract. 
    We would evaluate this information to determine if individuals who 
can control the outcome of work performed under a MIP contract may be 
unduly influenced by their own or their close relatives' business 
relationships or contracts. We need the information to protect the 
monies disbursed for both program and administrative services and to 
ensure that an offeror's/contractor's mitigation methods adequately 
eliminate any conflicts that exist due to relationships of an 
offeror's/contractor's officers, directors, or managers.
    Private sector participants at the December 6, 1996 open forum 
discussion expressed the opinion that full disclosure of all of an 
offeror's/contractor's relationships would ameliorate conflicts of 
interest. We considered that, while this might be appropriate in some 
MIP contractor procurements, it would be unduly burdensome and 
unnecessary as a blanket requirement in all MIP procurements. Instead, 
we identified information, described above, that we believe to be 
essential to the process and require this information to be disclosed 
in MIP procurements.
    The amount of burden associated with these requirements will 
generally decrease as the size of the offeror/contractor decreases. 
Smaller offerors/contractors and those not involved in the insurance 
industry may have no potential conflicts of interest to report if they 
do not participate in other lines of business and/or if they do not 
participate in lines of business related to the insurance, health, and 
health management and consulting industries that are likely to have 
potential conflicts of interest.
    Therefore, based on comments provided by the public and our prior 
experience, we expect the Certificate and supporting materials will 
take approximately 80 hours to prepare by each offeror/contractor for 
its own organization. This estimate is based on the fact that the 
majority of these disclosure requirements will be compiled using 
existing data, which an offeror/contractor uses to satisfy other 
business needs, and the assumption that approximately one-third of the 
offerors will not have any potential conflicts of interest to report. 
We expect 15 offerors for each MIP contract. The total burden 
referenced in this section is 1,200 burden hours.
    As required by section 3504(h) of the Paperwork Reduction Act of 
1995, we have submitted a copy of this document to the Office of 
Management and Budget (OMB) for its review of these information 
collection requirements.
    If you comment on these information collection and recordkeeping 
requirements, please mail copies directly to the following:

Health Care Financing Administration, Office of Financial and Human 
Resources, Management Planning and Analysis Staff, Attn: John Burke, 
Attn: HCFA-7020-P, Room C2-26-17, 7500 Security Boulevard, Baltimore, 
MD 21244-1850
Office of Information and Regulatory Affairs, Office of Management and 
Budget, Room 10235, New Executive Office Building, Washington, DC 
20503, Attn: Allison Herron Eydt, HCFA Desk Officer

V. Regulatory Impact Statement

A. Introduction

    We have examined the impacts of this proposed rule as required by 
Executive Order 12866 and the Regulatory Flexibility Act (RFA) (Public 
Law 96-354). Executive Order 12866 directs agencies to assess all costs 
and benefits of available regulatory alternatives and,

[[Page 13602]]

when regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, environmental, 
public health and safety effects, distributive impacts, and equity). 
The RFA requires agencies to analyze options for regulatory relief of 
small businesses. For purposes of the RFA, small entities include small 
businesses, non-profit organizations and governmental agencies. Most 
hospitals and most other providers and suppliers are small entities, 
either by nonprofit status or by having revenues of $5 million or less 
annually. Intermediaries and carriers are not considered to be small 
entities.
    Section 1102(b) of the Social Security Act requires us to prepare a 
regulatory impact analysis for any proposed rule that may have a 
significant impact on the operations of a substantial number of small 
rural hospitals. This analysis must conform to the provisions of 
section 603 of the RFA. For purposes of section 1102(b) of the Act, we 
define a small rural hospital as a hospital that is located outside a 
Metropolitan Statistical Area and has fewer than 50 beds.

B. Summary of the Proposed Rule

    As discussed in detail above, this rule implements section 1893 of 
the Act, which encourages proactive measures to combat waste, fraud, 
and abuse and to protect the integrity of the Medicare program. The 
objective of the proposed regulation is to provide a procurement 
procedure to supplement the requirements of the FAR and specifically 
address contracts to perform MIP functions identified in the law.
    As part of their existing contractual duties, both intermediaries 
and carriers must perform certain program integrity activities or 
payment safeguard activities. These activities include, but are not 
limited to, conducting review of claims to determine whether services 
were reasonable and necessary, deterring and detecting Medicare fraud, 
auditing provider cost reports, and ensuring that Medicare pays the 
appropriate amount when a beneficiary has other health insurance. This 
rule provides that these functions, as specified below, will be 
performed under new MIP contracts:
     Review of provider activities such as medical review, 
utilization review, and fraud review.
     Audit of cost reports.
     Medicare secondary payer review and payment recovery.
     Provider and beneficiary education on payment integrity 
and benefit quality assurance issues.
     Developing and updating lists of durable medical equipment 
items that are to be subject to prior approval provisions.

C. Discussion of Impact

    We expect that this rule will have a positive impact on the 
Medicare program, Medicare beneficiaries, providers, suppliers, and 
entities that have not previously contracted with us. It is possible 
that some providers and suppliers may experience a slight increase in 
administrative costs as their claims are subjected to closer review. 
Current intermediaries and carriers that seek award of MIP contracts 
may incur costs in complying with new requirements set forth in the 
rule, but the effect is not expected to be material. To the extent that 
small entities could be affected by the rule, and because the rule 
raises certain policy issues with respect to conflict of interest 
standards, we provide an impact analysis for those entities we believe 
will be most heavily affected by the rule.
    We believe that this rule will have an impact, although not a 
significant one, in five general areas. The Medicare program and Health 
Insurance Trust Funds, Medicare beneficiaries and taxpayers, entities 
that have not previously contracted with us, and Medicare providers and 
suppliers would benefit from the rule. Current intermediaries and 
carriers may experience a somewhat negative impact, although the effect 
on these organization should be tempered by the benefits the new rule 
will confer.
1. The Medicare Program and Health Insurance Trust Funds
    In recent years, sizable cuts in intermediaries' and carriers' 
budgets for program safeguards have diminished efforts to thwart 
improper billing practices. The Health Insurance Portability and 
Accountability Act provides for a direct apportionment from the Health 
Insurance Trust Funds for carrying out the MIP. Appropriations totaled 
$440 million for FY 1998 and $500 million for FY 1998. By FY 2003, 
appropriations are expected to grow to $720 million.
    Creating a separate and dependable long-term funding source for MIP 
will allow us the flexibility to invest in innovative strategies to 
combat the fraud and abuse drain on the Trust Funds. By shifting 
emphasis from post-payment recoveries on incorrectly paid claims to 
pre-payment strategies, most claims will be paid correctly the first 
time.
    Improper billing and health care fraud are difficult to quantify 
because of their hidden nature. However, a General Accounting Office 
(GAO) report on Medicare (GAO/HR-91-10, February 1997) suggests that by 
reducing unnecessary or inappropriate payments, the Federal Government 
would realize large savings and help slow the growth in Medicare costs. 
In this report, the GAO states that estimates of ``the costs of fraud 
and abuse ranging from 3 to 10 percent have been cited for health 
expenditures nationwide, so applying this range to Medicare suggests 
that such losses in fiscal year 1996 could have been from $6 billion to 
as much as $20 billion.''
    The savings realized from our payment safeguard activities for FYs 
1988-1996 were as follows:

------------------------------------------------------------------------
                                                   Total      Return on 
               Year                 Total cost   savings *    investment
----------------------------------------*-------------------------------
FY1988...........................       $313.6     $3,654.1         12:1
FY1989...........................        376.3      3,961.6         11:1
FY1990...........................        348.7      5,234.4         15:1
FY1991...........................        360.7      5,703.4         16:1
FY1992...........................        350.7      5,153.2         15:1
FY1993...........................        406.3      6,506.6         16:1
FY1994...........................        412.4      5,412.7         13:1
FY1995...........................        428.3      6,314.9         15:1
FY1996...........................        441.1      6,190.4        14:1 
------------------------------------------------------------------------
* Dollars in millions.                                                  


[[Page 13603]]

    In our Justification of Estimates for Appropriations Committees for 
fiscal year 1998, we projected the return on investment for various 
payment safeguard activities under MIP. Overall, we expect that every 
dollar expended in fiscal year 1998 to perform integrity functions will 
save $12 for the Medicare program. We estimate that medical review and 
utilization review performed under MIP will produce a return on 
investment of 8:1 for Part A claims and 14:1 for Part B claims. Every 
dollar spent on audit functions under MIP is expected to save $6 for 
the Medicare program. For Medicare secondary payer functions, we 
project a 50:1 return on investment for Part A claims and a 9:1 return 
for Part B claims. The overall return for Medicare secondary payer 
functions performed under MIP is estimated to be 26:1.
    In addition to these economic advantages, the Medicare program will 
benefit in a qualitative way. MIP, as this proposed rule would 
implement it, gives us a tool to better administer the Medicare program 
and accomplish our mission of providing access to quality health care 
for Medicare beneficiaries. Under this rule, program integrity 
activities will be performed under specialized contracts that are 
subject to more stringent conflict of interest standards than were 
previously employed. In addition, for the first time we will be able to 
use competitive procedures to separately contract for the performance 
of integrity functions. In general, economic theory postulates that 
competition results in a better price for the consumer who, in this 
instance, is HCFA on behalf of Medicare beneficiaries and taxpayers. 
Competition should also encourage the use of innovative techniques to 
perform integrity functions that will, in turn, result in more 
efficient and effective safeguards for the Trust Funds.
2. Medicare Beneficiaries and Taxpayers
    We expect that overall this rule would have a positive effect on 
Medicare beneficiaries and taxpayers. Beneficiaries pay deductibles and 
Part B Medicare premiums. Taxpayers, including those who are not yet 
eligible for Medicare, contribute part of their earnings to the Part A 
Trust Fund. Taxpayers and beneficiaries contribute indirectly to the 
Part B Trust Funds because it is funded, in part, from general tax 
revenues. Consistent performance of program integrity activities will 
ensure that less money is wasted on inappropriate treatment or 
unnecessary services. As a result, current and future beneficiaries 
will obtain more value for every Medicare dollar spent.
    Medicare contractors estimate that of the 130,000 calls they 
receive yearly concerning potential fraud and abuse, 94,000 are from 
beneficiaries, many of whom call to question the propriety of claims 
made on their behalf. Beneficiary education monies, especially when 
used to provide more Medicare ``scam alerts,'' will enhance a 
beneficiary's attention to detail and increase savings.
    Beneficiaries may experience higher denial rates due to the more 
stringent claims review. It is expected, however, that most of the 
potential increase in denials will result from a determination that the 
services provided were not reasonable and necessary under Medicare 
authorities and guidelines. There are established limitations on 
beneficiary liability when claims are denied on this basis; thus the 
impact on beneficiaries will be minimized.
3. Current Intermediaries and Carriers
    Although intermediaries and carriers are not considered small 
entities for purposes of the RFA, we are providing the following 
analysis. There are currently 43 Medicare intermediaries and 27 
Medicare carriers plus 4 durable medical equipment regional 
contractors. All but 13 of these contractors are Blue Cross/Blue Shield 
plans. Presently, all contractors perform payment safeguard activities, 
and, in FY 1996, approximately 28 percent of the total contractor 
budget was dedicated to program integrity.
    We considered prohibiting current intermediaries and carriers from 
entering into MIP contracts. We also considered entering into contracts 
with new organizations to perform all functions while simultaneously 
removing all payment safeguard functions from current contractors. 
Neither of these options appeared viable because the effect on the 
Medicare program would have been unduly disruptive. We do, however, 
expect to reduce the number of contractors when we shift and 
consolidate the integrity functions to MIP contractors, but the exact 
number cannot be determined until we begin implementing the program. 
The reduction in the number of contractors performing integrity 
functions does not mean that local contractor presence will be 
eliminated. Medical directors would continue to play an important role 
in benefit integrity activities, and we intend to retain locally-based 
medical directors to continue our relationship with local physicians by 
using groups like Carrier Advisory Committees. Locally-based fraud 
investigators and auditors are also likely to be used. Review policies 
will be coordinated across contractors to ensure consistency, but local 
practice will be incorporated where appropriate.
    This rule may have a negative impact on current intermediaries and 
carriers in some respects. Current contractors will lose a portion of 
their Medicare business as payment safeguard functions are transferred 
to MIP contractors. Although their workload will be reduced, the effect 
on current contractors will be gradual because we have a long-term 
strategy for the implementation of MIP. As discussed above, we believe 
that it would be too disruptive to the Medicare program to make a 
sudden, across-the-board change in contractors. The change will be made 
over time, in an incremental fashion, as MIP contracts are awarded; 
therefore, we cannot quantify the effect.
    On the other hand, current contractors would benefit from this 
proposed rule because, under its provisions, they are eligible to 
compete for MIP contracts as long as they comply with all conflict of 
interest and other requirements. (Current contractors may not receive 
payment for performing the same program integrity activities under both 
a MIP contract and their existing contract.) We considered proposing 
rules that identified specific conflict of interest situations that 
would prohibit the award of a MIP contract. We also considered 
prohibiting a MIP contractor whose contract was completed or terminated 
from competing for another MIP contract for a certain period. Instead, 
the proposed rule would establish a process for evaluating, on a case-
by-case basis, situations that may constitute conflicts of interest. It 
permits current contractors to position themselves to be eligible for a 
MIP contract by mitigating any conflicts of interest they may have in 
order to compete. The economic impact on intermediaries and carriers is 
lessened by the proposed approach when compared to the alternatives we 
considered.
    The current contractors who are awarded MIP contracts will also 
benefit from the consistent funding provided by the law for program 
integrity activities. This stable, long-term funding mechanism will 
allow Medicare contractors to attract, train, and retain qualified 
professional staff to perform claims review and audit, to identify and 
refer fraud cases to law enforcement agencies and to support the 
ongoing development of these cases for prosecution by the Department of 
Justice.
    There will be an economic impact on current contractors that 
propose to

[[Page 13604]]

perform MIP contracts using subcontractors. MIP contractors would be 
required to determine if any of their subcontractors, at any tier, have 
conflicts of interest and to ensure that any conflicts are mitigated. A 
MIP contractor would apply to its subcontractors the same conflict of 
interest standard to which it must adhere. It is impossible to assess 
the precise economic impact of this portion of the proposed rule 
because a MIP contractor is free to contract with any subcontractor. A 
MIP contractor may seek out subcontractors that are conflict free, 
which would reduce or eliminate the time expended monitoring conflict 
of interest situations.
4. New Contracting Entities
    Entities that have not previously performed Medicare payment 
safeguard activities will experience a positive effect from this rule. 
Integrity functions such as audit, medical review, and fraud 
investigation may be consolidated in a MIP contract to allow suspect 
claims to be identified and investigated from all angles. Contractors 
may subcontract for these specific integrity functions, thus creating 
new markets and opportunities for small, small disadvantaged, and 
woman-owned businesses.
    Use of full and open competition to award MIP contracts may 
encourage innovation and the creation of new technology. Historically, 
cutting edge technologies and analytical methodologies created for the 
Medicare program have benefitted the private insurance arena.
    This proposed rule, however, could also have an adverse economic 
impact on newly-contracting entities. They, like existing contractors, 
will be required to absorb the cost of mitigating conflicts of interest 
and complying with conflict of interest requirements.
5. Providers and Suppliers
    There could be some burden imposed on providers and suppliers that 
are small businesses or not-for-profit organizations by the need to 
deal with a new set of contractors. There are approximately 1 million 
health care providers and suppliers (depending on how group practices 
and multiple locations are counted) that bill independently. The 
proposed rule does not necessarily impose any action on the part of 
these providers and suppliers. It is possible that some of them would 
have to devote more effort in responding to MIP contractors' inquiries 
generated by more stringent claims review and that they could incur a 
modest increase in administrative costs. In our analysis of possible 
administrative costs to providers and suppliers, we assumed that a 
contractor would make two follow-up inquiries to a provider or supplier 
for each potential recovery of an incorrect payment. Assuming that the 
response to each inquiry would require a provider or supplier to expend 
30 minutes of clerical time, at $10 per hour, and 15 minutes of 
professional time, at $100 per hour, we estimate that the average 
response to an inquiry would cost $30. The resulting added cost to 
providers and suppliers would be under $10 million annually.
    Most Medicare contractors do not maintain toll-free lines for 
providers or suppliers. A provider's or supplier's telephone bill could 
increase if it must contact a MIP contractor that is out of its calling 
area. However, it is possible that a provider's or supplier's 
intermediary or carrier may also be its MIP contractor. We believe that 
the centralization of certain functions would result in more consistent 
policy and lessen the need for a provider or supplier to communicate 
with its contractor. Since we plan to phase-in the transfer of the MIP 
activities, we do not anticipate a significant annual impact on 
telephone bills.
    Overall, we expect that providers and suppliers will benefit 
qualitatively from this proposed rule. Many providers and suppliers 
perceive that their reputations are tarnished by the few dishonest 
providers and suppliers that take advantage of the Medicare program. 
The media often focus on the most egregious cases of Medicare fraud and 
abuse, leaving the public with the perception that physicians and other 
health care practitioners routinely make improper claims. This rule 
would allow us to take a more effective and wider ranging approach to 
identifying, stopping, and recovering from unscrupulous providers and 
suppliers. As the number of dishonest providers and suppliers and 
improper claims diminishes, ethical providers and suppliers will 
benefit.
    This proposed rule could be considered to have a negative impact on 
any provider or supplier that routinely submits questionable claims and 
would impact those that have been receiving inappropriate payments. 
Since the objective of this proposed rule is to eliminate improper 
payments, we will not analyze the effect the rule may have on 
unscrupulous providers or suppliers. We do not believe that this rule 
will reduce a provider's or supplier's legitimate income from Medicare. 
As claims are more closely and systematically reviewed, providers and 
suppliers may experience an increase in the number of claims denied. 
This slight negative impact should decrease as providers become more 
knowledgeable regarding what claims are appropriate.

D. Conclusion

    We conclude that money would be saved and the solvency of the Trust 
Funds extended as a result of this proposed rule. The dynamic nature of 
fraud and abuse is illustrated by the fact that wrongdoers continue to 
find ways to evade safeguards. This supports the need for constant 
vigilance and increasingly sophisticated ways to protect against 
``gaming'' of the system. We solicit public comments as well as data on 
the extent to which any of the affected entities would be significantly 
economically affected by this proposed rule. However, based on the 
above analysis, we have determined, and certify, that this proposed 
rule would not have a significant economic impact on a substantial 
number of small entities. We also have determined, and certify, that 
this proposed rule would not have a significant impact on the 
operations of a substantial number of small rural hospitals. In 
accordance with the provisions of Executive Order 12866, this proposed 
rule was reviewed by the Office of Management and Budget.

List of Subjects

42 CFR Part 400

    Grant programs--health, Health facilities, Health maintenance 
organizations (HMO), Medicaid, Medicare, Reporting and recordkeeping 
requirements.

42 CFR Part 421

    Administrative practice and procedure, Health facilities, Health 
professions, Medicare, Reporting and recordkeeping requirements.

    42 CFR chapter IV would be amended as follows:
A. Part 400

PART 400--INTRODUCTION; DEFINITIONS

    1. The authority citation for part 400 continues to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh) and 44 U.S.C. Chapter 35.

    2. Section 400.202 is amended by adding the following definition in 
alphabetical order, to read as follows:


Sec. 400.202  Definitions specific to Medicare.

* * * * *
    Medicare integrity program contractor means an entity that has a 
contract with

[[Page 13605]]

HCFA under section 1893 of the Act to perform program integrity 
activities.
* * * * *
B. Part 421

PART 421--MEDICARE CONTRACTING

    1. The part heading is revised to read as set forth above.
    2. The authority citation for part 421 continues to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).

    3. Section 421.1 is revised to read as follows:


Sec. 421.1  Basis, applicability, and scope.

    (a) Basis. This part is based on the indicated provisions of the 
following sections of the Act:

    1124--Requirements for disclosure of certain information.
    1816 and 1842--Use of organizations and agencies in making 
Medicare payments to providers and suppliers of services.
    1893--Requirements for protecting the integrity of the Medicare 
program.

    (b) Additional basis. Section 421.118 is also based on 42 U.S.C. 
1395(b)-1(a)(1)(F), which authorizes demonstration projects involving 
intermediary agreements and carrier contracts.
    (c) Applicability. The provisions of this part apply to agreements 
with Part A (Hospital Insurance) intermediaries, contracts with Part B 
(Supplementary Medical Insurance) carriers, and contracts with Medicare 
integrity program contractors that perform program integrity functions.
    (d) Scope. The provisions of this part state that HCFA may perform 
certain functions directly or by contract. They specify criteria and 
standards HCFA uses in selecting intermediaries and evaluating their 
performance, in assigning or reassigning a provider or providers to 
particular intermediaries, and in designating regional or national 
intermediaries for certain classes of providers. The provisions provide 
the opportunity for a hearing for intermediaries and carriers affected 
by certain adverse actions. They also provide adversely affected 
intermediaries an opportunity for judicial review of certain hearing 
decisions. They also set forth requirements related to contracts with 
Medicare integrity program contractors.
    4. Section 421.100 is revised to read as follows:


Sec. 421.100  Intermediary functions.

    An agreement between HCFA and an intermediary specifies the 
functions to be performed by the intermediary.
    (a) Mandatory functions. The contract must include the following 
functions:
    (1) Determining the amount of payments to be made to providers for 
covered services furnished to Medicare beneficiaries.
    (2) Making the payments.
    (b) Additional functions. The contract may include any or all of 
the following functions:
    (1) Any or all of the program integrity functions described in 
Sec. 421.304, provided the intermediary is continuing those functions 
under an agreement entered into under section 1816 of the Act that was 
in effect on August 21, 1996, and they do not duplicate work being 
performed under a Medicare integrity program contract.
    (2) Undertaking to adjust incorrect payments and recover 
overpayments when it has been determined that an overpayment has been 
made.
    (3) Furnishing to HCFA timely information and reports that HCFA 
requests in order to carry out its responsibilities in the 
administration of the Medicare program.
    (4) Establishing and maintaining procedures as approved by HCFA for 
the review and reconsideration of payment determinations.
    (5) Maintaining records and making available to HCFA the records 
necessary for verification of payments and for other related purposes.
    (6) Upon inquiry, assisting individuals with respect to matters 
pertaining to an intermediary contract.
    (7) Serving as a channel of communication to and from HCFA of 
information, instructions, and other material as necessary for the 
effective and efficient performance of an intermediary agreement.
    (8) Undertaking other functions as mutually agreed to by HCFA and 
the intermediary.
    (c) Dual intermediary responsibilities. With respect to the 
responsibility for services to a provider-based HHA or a provider-based 
hospice, when different intermediaries serve the HHA or hospice and its 
parent provider under Sec. 421.117, the designated regional 
intermediary determines the amount of payment and makes payments to the 
HHA or hospice. The intermediary and/or Medicare integrity program 
contractor serving the parent provider performs fiscal functions, 
including audits and settlement of the Medicare cost reports and the 
HHA and hospice supplement worksheets.
    5. Section 421.200 is revised to read as follows:


Sec. 421.200  Carrier functions.

    A contract between HCFA and a carrier specifies the functions to be 
performed by the carrier. The contract may include any or all of the 
following functions:
    (a) Any or all of the program integrity functions described in 
Sec. 421.304 provided--
    (1) The carrier is continuing those functions under a contract 
entered into under section 1842 of the Act that was in effect on August 
21, 1996; and
    (2) The functions do not duplicate work being performed under a 
Medicare integrity program contract, except that the function related 
to developing and maintaining a list of durable medical equipment may 
be performed under both a carrier contract and a Medicare integrity 
program contract.
    (b) Receiving, disbursing, and accounting for funds in making 
payments for services furnished to eligible individuals within the 
jurisdiction of the carrier.
    (c) Determining the amount of payment for services furnished to an 
eligible individual.
    (d) Undertaking to adjust incorrect payments and recover 
overpayments when it has been determined that an overpayment has been 
made.
    (e) Furnishing to HCFA timely information and reports that HCFA 
requests in order to carry out its responsibilities in the 
administration of the Medicare program.
    (f) Maintaining records and making available to HCFA the records 
necessary for verification of payments and for other related purposes.
    (g) Establishing and maintaining procedures under which an 
individual enrolled under Part B will be granted an opportunity for a 
fair hearing.
    (h) Upon inquiry, assisting individuals with matters pertaining to 
a carrier contract.
    (i) Serving as a channel of communication to and from HCFA of 
information, instructions, and other material as necessary for the 
effective and efficient performance of a carrier contract.
    (j) Undertaking other functions as mutually agreed to by HCFA and 
the carrier.
    6. A new subpart D is added to part 421 to read as follows:

Subpart D--Medicare Integrity Program Contractors

Sec.
421.300  Basis, applicability, and scope.
421.302  Eligibility requirements for Medicare integrity program 
contractors.
421.304  Medicare integrity program contractor functions.
421.306  Awarding of a contract.
421.308  Renewal of a contract.
421.310  Conflict of interest identification.
421.312  Conflict of interest evaluation.

[[Page 13606]]

421.314  Conflict of interest resolution.
421.316  Limitation on Medicare integrity program contractor 
liability.

Subpart D--Medicare Integrity Program Contractors


Sec. 421.300  Basis, applicability, and scope.

    (a) Basis. This subpart implements section 1893 of the Act, which 
requires HCFA to protect the integrity of the Medicare program by 
entering into contracts with eligible entities to carry out Medicare 
integrity program functions.
    (b) Applicability. This subpart applies to entities that seek to 
compete or receive award of a contract under section 1893 of the Act 
including entities that perform functions under this subpart emanating 
from the processing of claims for individuals entitled to benefits as 
qualified railroad retirement beneficiaries.
    (c) Scope. This subpart defines the types of entities eligible to 
become Medicare integrity program contractors; identifies the program 
integrity functions a Medicare integrity program contractor performs; 
describes procedures for awarding and renewing contracts; establishes 
procedures for identifying, evaluating, and resolving organizational 
conflicts of interest; prescribes responsibilities; and sets forth 
limitations on contractor liability. The provisions of this subpart are 
based on the acquisition regulations set forth at 48 CFR Chapters 1 and 
3.


Sec. 421.302  Eligibility requirements for Medicare integrity program 
contractors.

    If an entity meets the following conditions, HCFA may enter into a 
contract with it to perform the functions described in Sec. 421.304:
    (a) Demonstrates the ability to perform the Medicare integrity 
program contractor functions described in Sec. 421.304. For purposes of 
developing and periodically updating a list of DME under 
Sec. 421.304(e), an entity is deemed to be eligible to enter into a 
contract under the Medicare integrity program to perform the function 
if the entity is a carrier with a contract in effect under section 1842 
of the Act.
    (b) Agrees to cooperate with the OIG, the Attorney General, and 
other law enforcement agencies, as appropriate, including making 
referrals, in the investigation and deterrence of fraud and abuse of 
the Medicare program.
    (c) Complies with conflict of interest provisions in 48 CFR 
Chapters 1 and 3 and is not excluded under the conflict of interest 
provision at Sec. 421.310.
    (d) Meets other requirements that HCFA establishes.


Sec. 421.304  Medicare integrity program contractor functions.

    The contract between HCFA and a Medicare integrity program 
contractor specifies the functions the contractor performs. The 
contract may include any or all of the following functions:
    (a) Conducting medical reviews, utilization reviews, and fraud 
reviews related to the activities of providers of services and other 
individuals and entities (including entities contracting with HCFA 
under part 417 of this chapter) furnishing services for Medicare 
payment. These reviews include medical, utilization, and fraud reviews.
    (b) Auditing cost reports of providers of services, or other 
individuals or entities (including entities contracting with HCFA under 
part 417 of this chapter), as necessary to ensure proper Medicare 
payment.
    (c) Determining appropriate Medicare payment to be made for 
services, as specified in section 1862(b) of the Act, and taking action 
to recover inappropriate payments.
    (d) Educating providers, suppliers, beneficiaries, and other 
persons regarding payment integrity and benefit quality assurance 
issues.
    (e) Developing, and periodically updating, a list of items of 
durable medical equipment that are frequently subject to unnecessary 
utilization throughout the contractor's entire service area or a 
portion of the area, in accordance with section 1834(a)(15)(A) of the 
Act.


Sec. 421.306  Awarding of a contract.

    (a) HCFA awards Medicare integrity program contracts in accordance 
with acquisition regulations set forth at 48 CFR chapters 1 and 3, this 
subpart, and all other applicable laws and regulations. These 
requirements for awarding Medicare integrity program contracts are 
used--
    (1) When entering into new contracts;
    (2) When entering into contracts that may result in the elimination 
of responsibilities of an individual intermediary or carrier under 
section 1816(l) or section 1842(c) of the Act, respectively; and
    (3) At any other time HCFA considers appropriate.
    (b) HCFA may award an entity a Medicare integrity program contract 
without competition if--
    (1) Through approval of a novation agreement, HCFA recognizes the 
entity as the successor in interest to an intermediary agreement or 
carrier contract under which the intermediary or carrier was performing 
activities described in section 1893(b) of the Act on August 21, 1996;
    (2) The intermediary or carrier has transferred to the entity all 
of the resources, including personnel, that were involved in 
performance under the intermediary agreement or carrier contract and 
performance of Medicare integrity program activities; and
    (3) The intermediary or carrier continued to perform Medicare 
integrity program activities until transferring the resources to the 
entity.
    (c) An entity is eligible to be awarded a Medicare integrity 
program contract only if it meets the eligibility requirements 
established in Sec. 421.302.


Sec. 421.308 Renewal of a contract.

    (a) HCFA specifies an initial contract term in the Medicare 
integrity program contract. Contracts under this subpart may contain 
renewal clauses. HCFA may renew the Medicare integrity program 
contract, without regard to any provision of law requiring competition, 
as it determines to be appropriate, by giving the contractor notice, 
within timeframes specified in the contract, of its intent to do so.
    (b) HCFA may renew a Medicare integrity program contract without 
competition if--
    (1) The Medicare integrity program contractor continues to meet the 
requirements established in this subpart;
    (2) The Medicare integrity program contractor meets or exceeds all 
of the performance requirements established in its current contract; 
and
    (3) It is in the best interest of the Government.
    (c) If HCFA does not renew a contract, the contract will end in 
accordance with its terms, and the contractor does not have the right 
to a hearing or judicial review of the nonrenewal decision.


Sec. 421.310  Conflict of interest identification.

    (a) Definitions. As used in this subpart, the following definitions 
apply:
    Financial relationship means--
    (1) A direct or indirect ownership or investment interest 
(including an option or nonvested interest) in any entity that exists 
through equity, debt, or other means and includes any indirect 
ownership or investment interest no matter how many levels removed from 
a direct interest; or
    (2) A compensation arrangement with an entity.
    Organizational conflict of interest has the meaning given at 48 CFR 
9.501, except that, for purposes of this subpart, the activities and 
relationships described include those of the offeror or contractor 
itself and other business

[[Page 13607]]

related to it and those of its officers, directors (including medical 
directors), managers, and subcontractors.
    (b) General. Except as provided in paragraph (d) of this section, 
HCFA does not enter into a contract under this subpart with an offeror 
or contractor that HCFA determines has, or has the potential for, an 
unresolved organizational conflict of interest.
    (c) Identification of conflict. (1) HCFA determines that an offeror 
or contractor has an organizational conflict of interest, or the 
potential for the conflict exists, if--
    (i) The offeror or contractor is an entity described in paragraph 
(c)(3) of this section; or
    (ii) The offeror or contractor has a present, or known future, 
direct or indirect financial relationship with an entity described in 
paragraph (c)(3) of this section.
    (2) A financial relationship may exist either--
    (i) Through an offeror's or contractor's parent companies, 
subsidiaries, affiliates, subcontractors, or current clients; or
    (ii) From the activities and relationships of the officers, 
directors (including medical directors), or managers of the offeror or 
contractor and may be either direct or indirect. An officer, director, 
or manager has an indirect financial relationship if an ownership or 
investment interest is held in the name of another but provides 
benefits to the officer, director, or manager. Examples of indirect 
financial relationships are holdings in the name of a spouse or 
dependent child of the officer, director, or manager and holdings of 
other relatives who reside with the officer, director, or manager.
    (3) For purposes of paragraphs (c)(1)(i) and (c)(1)(ii) of this 
section, the entity is one that--
    (i) Provides, insures, or pays for health benefits, with the 
exception of health plans provided as the entity's employee fringe 
benefit;
    (ii) Conducts audits of health benefit payments or cost reports;
    (iii) Conducts statistical analysis of health benefit utilization;
    (iv) Would review or does review, under the contract, Medicare 
services furnished by a provider or supplier that is a direct 
competitor of the offeror or contractor;
    (v) Prepared work or is under contract to prepare work that would 
be reviewed under the Medicare program integrity contract;
    (vi) Is affiliated, as that term is explained in 48 CFR 19.101, 
with a provider or supplier to be reviewed under the contract.
    (4) HCFA may determine that an offeror or contractor has an 
organizational conflict of interest, or the potential for a conflict 
exists, based on the following:
    (i) Apparent organizational conflicts of interest. An apparent 
organizational conflict of interest exists if a prudent business person 
has cause to believe that the offeror or contractor would have a 
conflict of interest in performing the requirements of a contract under 
this subpart. No inappropriate action by the offeror or contractor is 
necessary for an apparent organizational conflict of interest to exist.
    (ii) Other contracts and grants with the Federal Government.
    (d) Exception. HCFA may contract with an offeror or contractor that 
has an unresolved conflict of interest if HCFA determines that it is in 
the best interest of the Government to do so.
    (e) Offeror's or contractor's responsibility with regard to 
subcontractors. An offeror or contractor is responsible for determining 
whether an organizational conflict of interest exists in any of its 
proposed or actual subcontractors at any tier and is responsible for 
ensuring that the subcontractors have mitigated any conflict of 
interest or potential conflict of interest.
    (f) Post-award conflicts of interest. (1) In addition to the 
conflicts identified in paragraph (c) of this section, HCFA considers 
that a conflict of interest has occurred if during the term of the 
contract--
    (i) The contractor receives any fee, compensation, gift, payment of 
expenses, or any other thing of value from any entity that is reviewed, 
audited, investigated, or contacted during the normal course of 
performing activities under the Medicare integrity program contract; or
    (ii) HCFA determines that the contractor's activities are creating 
a conflict of interest.
    (2) In the event HCFA determines that a conflict of interest exists 
during the term of the contract, among other actions, it may, as it 
deems appropriate--
    (i) Not renew the contract for an additional term;
    (ii) Modify the contract; or
    (iii) Terminate the contract.


Sec. 421.312  Conflict of interest evaluation.

    (a) Disclosure. Offerors that wish to be eligible for the award of 
a contract under this subpart and Medicare integrity program 
contractors must submit, at times specified in paragraph (b) of this 
section, an Organizational Conflicts of Interest Certificate. The 
Certificate must contain the information specified in paragraphs (a)(1) 
through (a)(8) of this section, unless the information has otherwise 
been provided in the proposal, in which case it must be referenced. 
Each solicitation issued for a contract under this subpart contains the 
requirements for disclosure for pre- and post-award purposes. The 
solicitation may require more detailed information than identified in 
this section.
    (1) A description of all business or contractual relationships or 
activities that may be viewed by a prudent business person as a 
conflict of interest.
    (2) A description of the methods the offeror or contractor will 
apply to mitigate any situations listed in the Certificate that could 
be identified as a conflict of interest.
    (3) A description of the offeror's or contractor's program to 
monitor its compliance and the compliance of its proposed and actual 
subcontractors with the conflict of interest requirements as identified 
in the relevant solicitation.
    (4) A description of the offeror's or contractor's plans to 
contract with an independent auditor to conduct a compliance audit.
    (5) An affirmation, using language that HCFA may prescribe, signed 
by an official authorized to bind the contractor, that the offeror or 
contractor understands that HCFA may consider any deception or omission 
in the Certificate grounds for nonconsideration for contract award in 
the procurement process, termination of the contract, or other contract 
or legal action.
    (6) Corporate and organizational structure.
    (7) Financial interests in other entities, including the following:
    (i) Percentage of ownership in any other entity.
    (ii) Income generated from other sources.
    (iii) A list of current or known future contracts or arrangements, 
regardless of size, with any--
    (A) Insurance organization or subcontractor of an insurance 
organization; or
    (B) Providers or suppliers furnishing health services for which 
payment may be made under the Medicare program.
    (iv) In the case of contracts or arrangements identified in 
accordance with paragraph (a)(7)(iii) of this section, the dollar 
amount of the contracts or arrangements, the type of work performed, 
and the period of performance.
    (8) The following information for all of the offeror's or 
contractor's officers, directors (including medical directors),

[[Page 13608]]

and managers who would be or are involved with the performance of the 
Medicare integrity program contract:
    (i) The information required under paragraphs (a)(1), (a)(7)(iii), 
and (a)(7)(iv) of this section.
    (ii) If required by the solicitation, the information specified in 
paragraphs (a)(7)(i) and (a)(7)(ii) of this section.
    (b) When disclosure is made. The Organizational Conflicts of 
Interest Certificate is submitted--
    (1) With the offeror's proposal;
    (2) When the HCFA Contracting Officer requests a revision in the 
Certificate;
    (3) As part of a compliance audit by an independent auditor; and
    (4) 45 days before any change in the information submitted in 
accordance with paragraph (a) or paragraph (b) of this section. Only 
changed information must be submitted.
    (c) Evaluation. HCFA evaluates organizational conflicts of interest 
and potential conflicts, using the information provided in the 
Organizational Conflicts of Interest Certificate, in order to promote 
the effective and efficient administration of the Medicare program.
    (d) Protection of proprietary information disclosed. (1) HCFA 
protects disclosed proprietary information as allowed under the Freedom 
of Information Act (5 U.S.C. 552).
    (2) HCFA requires signed statements from HCFA personnel with access 
to proprietary information that prohibit personal use during the 
procurement process and term of the contract.


Sec. 421.314  Conflict of interest resolution.

    (a) Review Board. HCFA establishes a Conflicts of Interest Review 
Board to resolve organizational conflicts of interest and determines 
when the Board is convened.
    (b) Resolution. Resolution of an organizational conflict of 
interest is a determination that--
    (1) The conflict has been mitigated;
    (2) The conflict precludes award of a contract to the offeror;
    (3) The conflict requires that HCFA modify an existing contract;
    (4) The conflict requires that HCFA terminate an existing contract; 
or
    (5) It is in the best interest of the Government to contract with 
the offeror or contractor even though the conflict exists.


Sec. 421.316  Limitation on Medicare integrity program contractor 
liability.

    (a) None of the following will be held by reason of the performance 
of any duty, function, or activity required or authorized under this 
subpart or under a valid contract entered into under this subpart to 
have violated any criminal law or to be civilly liable under any law of 
the United States or of any State (or political subdivision thereof) 
provided due care was exercised in that performance:
    (1) An entity having a contract with HCFA under this subpart (that 
is, a contractor under this subpart).
    (2) A person employed by or who has a fiduciary relationship with 
or who furnishes professional services to a contractor under this 
subpart.
    (b) HCFA makes payment, to a contractor under this subpart, or to a 
member or employee of the contractor, or to any person who furnishes 
legal counsel or services to the contractor, of an amount equal to the 
reasonable amount of the expenses incurred in connection with the 
defense of a suit, action, or proceeding, as determined by HCFA, if--
    (1) The suit, action, or proceeding was brought against the 
contractor, or a member or employee of the contractor, by a third party 
and relates to the performance by the contractor, member, or employee 
of any duty, function, or activity under a contract entered into with 
HCFA under this subpart;
    (2) The funds are available; and
    (3) The expenses are otherwise allowable under the terms of the 
contract.

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: March 5, 1998.
Nancy-Ann Min DeParle,
Administrator, Health Care Financing Administration.

    Approved: March 16, 1998.
Donna E. Shalala,
Secretary.
[FR Doc. 98-7190 Filed 3-16-98; 5:00 pm]
BILLING CODE 4120-01-P