Federal Register / Vol. 62, No. 237 / Wednesday, December 10, 1997 / Proposed Rules 65049

the Federal Register. This rule is not a

‘‘major rule’’ as defined by 5 U.S.C.

804(2).

List of Subjects in 40 CFR Part 52

Environmental protection, Air

pollution control, Hydrocarbons,

Intergovernmental relations, New source

review, Nitrogen dioxide, Particulate

matter, Reporting, and recordkeeping

requirements, Sulfur dioxide, Volatile

organic compounds.

Authority: 42 U.S.C. 7401, et seq.

Dated: November 14, 1997.

David A. Ullrich,

Acting Regional Administrator, Region 5.

[FR Doc. 97–31280 Filed 12–9–97; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 63

[FRL–5932–2]

Approval of Section 112(l) Authority for

Hazardous Air Pollutants;

Perchloroethylene Air Emission

Standards for Dry Cleaning Facilities;

State of California; San Luis Obispo

County Air Pollution Control District

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: Pursuant to section 112(l) of

the Clean Air Act (CAA) and through

the California Air Resources Board, San

Luis Obispo County Air Pollution

Control District (SLOCAPCD) requested

approval to implement and enforce its

‘‘Rule 432: Perchloroethylene Dry

Cleaning Operations’’ (Rule 432) in

place of the ‘‘National

Perchloroethylene Air Emission

Standards for Dry Cleaning Facilities’’

(dry cleaning NESHAP) for area sources

under SLOCAPCD’s jurisdiction. In the

Rules section of this Federal Register,

EPA is granting SLOCAPCD the

authority to implement and enforce

Rule 432 in place of the dry cleaning

NESHAP for area sources under

SLOCAPCD’s jurisdiction as a direct

final rule without prior proposal

because the Agency views this as a

noncontroversial action and anticipates

no adverse comments. A detailed

rationale for this approval is set forth in

the direct final rule. If no adverse

comments are received in response to

this proposed rule, no further activity is

contemplated in relation to this rule. If

EPA receives adverse comments, the

direct final rule will be withdrawn and

all public comments received will be

addressed in a subsequent final rule

based on this proposed rule. The EPA

will not institute a second comment

period on this document. Any parties

interested in commenting on this action

should do so at this time.

DATES: Comments on this proposed rule

must be received in writing by January

9, 1998.

ADDRESSES: Written comments on this

action should be addressed to: Andrew

Steckel, Rulemaking Office (AIR–4), Air

Division, U.S. Environmental Protection

Agency, Region IX, 75 Hawthorne

Street, San Francisco, CA 94105–3901.

Copies of the submitted request are

available for public inspection at EPA’s

Region IX office during normal business

hours.

FOR FURTHER INFORMATION CONTACT: Mae

Wang, Rulemaking Office (AIR–4), Air

Division, U.S. Environmental Protection

Agency, Region IX, 75 Hawthorne

Street, San Francisco, CA 94105–3901,

Telephone: (415) 744–1200.

SUPPLEMENTARY INFORMATION: This

document concerns SLOCAPCD Rule

432, Perchlorothylene Dry Cleaning

Operations, adopted on November 13,

1996. For further information, please see

the information provided in the direct

final action which is located in the

Rules section of this Federal Register.

Authority: This action is issued under the

authority of Section 112 of the Clean Air Act,

as amended, 42 U.S.C. Section 7412.

Dated: November 23, 1997.

Felicia Marcus,

Regional Administrator.

[FR Doc. 97–32330 Filed 12–9–97; 8:45 am]

BILLING CODE 6560–50–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of Inspector General

42 CFR Part 1001

Solicitation of New Safe Harbors and

Special Fraud Alerts

AGENCY: Office of Inspector General

(OIG), HHS.

ACTION: Notice of intent to develop

regulations.

SUMMARY: In accordance with section

205 of the Health Insurance Portability

and Accountability Act (HIPAA) of

1996, this notice solicits proposals and

recommendations for developing new

and modifying existing safe harbor

provisions under the Federal and State

health care programs’ anti-kickback

statute, as well as developing new OIG

Special Fraud Alerts. The purpose of

developing these documents is to clarify

OIG enforcement policy with regard to

program fraud and abuse.

DATES: To assure consideration, public

comments must be delivered to the

address provided below by no later than

5 p.m. on February 9, 1998.

ADDRESSES: Please mail or deliver your

written comments to the following

address: Office of Inspector General,

Department of Health and Human

Services, Attention: OIG–21–N, Room

5246, Cohen Building, 330

Independence Avenue, S.W.,

Washington, D.C. 20201. We do not

accept comments by facsimile (FAX)

transmission. In commenting, please

refer to file code OIG–21–N. 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 5541 of the Office of Inspector

General at 330 Independence Avenue,

S.W., Washington, D.C., on Monday

through Friday of each week from 8:00

a.m. to 4:30 p.m.

FOR FURTHER INFORMATION CONTACT: Joel

Schaer, (202) 619–0089, OIG

Regulations Officer.

SUPPLEMENTARY INFORMATION:

I. Background

A. The OIG Safe Harbor Provisions

Section 1128B(b) of the Social

Security Act (the Act) (42 U.S.C. 1320a–

7b(b)) provides criminal penalties for

individuals or entities that knowingly

and willfully offer, pay, solicit or

receive remuneration in order to induce

business reimbursed under the Federal

or State health care programs. The

offense is classified as a felony, and is

punishable by fines of up to $25,000

and imprisonment for up to 5 years.

The types of remuneration covered

specifically include kickbacks, bribes,

and rebates, whether made directly or

indirectly, overtly or covertly, or in cash

or in kind. In addition, prohibited

conduct includes not only remuneration

intended to induce referrals of patients,

but remuneration intended to induce

the purchasing, leasing, ordering, or

arranging for any good, facility, service,

or item paid for by Federal or State

health care programs.

Since the statute on its face is so

broad, concern has been expressed for

many years that some relatively

innocuous commercial arrangements are

technically covered by the statute and

are, therefore, subject to criminal

prosecution. As a response to the above

concern, the Medicare and Medicaid

Patient and Program Protection Act of

1987, section 14 of Public Law 100–93,
65050 Federal Register / Vol. 62, No. 237 / Wednesday, December 10, 1997 / Proposed Rules

specifically required the development

and promulgation of regulations, the socalled ‘‘safe harbor’’ provisions,

designed to specify various payment

and business practices which, although

potentially capable of inducing referrals

of business under the Federal and State

health care programs, would not be

treated as criminal offenses under the

anti-kickback statute (section 1128B(b)

of the Act; 42 U.S.C. 1320a–7b(b)) and

would not serve as a basis for a program

exclusion under section 1128(b)(7) of

the Act; 42 U.S.C. 1320a–7(b)(7). The

OIG safe harbor provisions have been

developed ‘‘to limit the reach of the

statute somewhat by permitting certain

non-abusive arrangements, while

encouraging beneficial and innocuous

arrangements’’ (56 FR 35952, July 29,

1991). Health care providers and others

may voluntarily seek to comply with

these provisions so that they have the

assurance that their business practices

are not subject to any enforcement

action under the anti-kickback statute or

program exclusion authority.

To date, the OIG has developed and

codified in 42 CFR 1001.952 a total of

13 final safe harbors that describe

practices that are sheltered from

liability, and is continuing to finalize 8

additional safe harbor provisions (see

the OIG notice of proposed rulemaking

at 58 FR 49008, September 21, 1993).

B. OIG Special Fraud Alerts

In addition, the OIG has also

periodically issued Special Fraud Alerts

to give continuing guidance to health

care providers with respect to practices

the OIG regards as unlawful. These

Special Fraud Alerts serve to notify the

health care industry that the OIG has

become aware of certain abusive

practices that the OIG plans to pursue

and prosecute, or to bring civil and

administrative action, as appropriate.

The Special Fraud Alerts also serve as

a tool to encourage industry compliance

by giving providers an opportunity to

examine their own practices. The OIG

Special Fraud Alerts are intended for

extensive distribution directly to the

health care provider community, as well

as those charged with administering the

Medicare and Medicaid programs.

In developing these Special Fraud

Alerts, the OIG has relied on a number

of sources and has consulted directly

with experts in the subject field,

including those within the OIG, other

agencies of the Department, other

Federal and State agencies, and those in

the health care industry. To date, eight

individual Special Fraud Alerts have

been issued by the OIG and

subsequently reprinted in the Federal

Register on December 19, 1994 (59 FR

65372), August 10, 1995 (60 FR 40847)

and June 17, 1996 (61 FR 30623).

C. Section 205 of Public Law 104–191

In accordance with the Health

Insurance Portability and

Accountability Act of 1996 (Public Law

104–191), the Department is now

required to provide additional formal

guidance regarding the application of

the anti-kickback statute and the safe

harbor provisions, as well as other OIG

health care fraud and abuse sanctions.

In addition to accepting and responding

to requests for advisory opinions to

outside parties regarding the

interpretation and applicability of

certain statutes relating to the Federal

and State health care programs, section

205 of Public Law 104–191 requires the

Department to develop and publish an

annual notice in the Federal Register

formally soliciting proposals for (1)

modifying existing safe harbors, and (2)

developing new safe harbors and OIG

Special Fraud Alerts. After considering

such proposals and recommendations,

the Department, in consultation with

the Department of Justice, will consider

the issuance of new or modified safe

harbor regulations, as appropriate. In

addition, the OIG will consider the

issuance of additional Special Fraud

Alerts.

On December 31, 1996, the

Department published the first of these

annual Federal Register notice

solicitations (61 FR 69060) addressing

proposals and recommendations for

developing new and modifying existing

safe harbor provisions under the Federal

and State health care programs’ antikickback statute, as well as developing

new OIG Special Fraud Alerts. As a

result, the OIG received a total of 32

timely-filed public comments from a

cross-section of organizations,

associations and other outside entities.

In response to that solicitation,

respondents raised a number of issues

and comments on a variety of areas,

including general comments concerning

application of the existing safe harbor

provisions, and specific concerns over

the existing safe harbors presently

codified in 42 CFR 1001.952 and those

proposed in our September 1993 notice

of proposed rulemaking. Respondents

also recommended new safe harbors for,

among other practices and

arrangements: (1) physician ownership

of hospitals; (2) provider sponsorship or

support of continuing education

programs for health care practitioners

and facilities; (3) provision of cataract

surgery-related prosthetic devices; (4)

loans between parties in a position to

refer or arrange for the referral of

Medicare covered items; (5) de minimis

gifts to beneficiaries for recommending

new patients; (6) intercorporate transfers

among entities delivering health care

through integrated delivery systems;

and (7) payments for purposes of

physician retention.

Special Fraud Alerts were also

suggested to address such areas as: (1)

financial arrangements between

hospitals and hospital-based physicians;

(2) billing management consultants; (3)

hospital discharges and transfers; (4)

food vendor ‘‘value added’’ services;

and (5) demands for discounts by

Medigap insurers.

The array of proposals and

recommendations received for new safe

harbors and Special Fraud Alerts are

summarized below, and are still under

review within the OIG. When the OIG

has fully assessed the merits of these

recommendations, we will consider the

promulgation of formal proposed

regulations to create new safe harbors

for those proposals deemed appropriate.

II. Summary of Previously Submitted

Recommendations for New Safe

Harbors and OIG Special Fraud Alerts

Set forth below is a summary of the

major topics previously submitted for

consideration in the OIG development

of new safe harbors and Fraud Alerts.

This listing serves to outline the major

concepts and specific proposals

received by this office as a result of the

December 1996 solicitation notice. The

OIG is currently taking these

recommendations under advisement,

and is not seeking additional public

comment on these proposals at this

time.

A. Proposed New Safe Harbors

Interface With the Stark Law

Commenters indicated that physician

groups are closely regulated by both the

anti-kickback statute and the physician

self-referral laws, i.e., the Stark

provisions. Since many existing safe

harbors are similar but not identical to

the statutory exceptions under the Stark

law, commenters indicated that

physician groups are forced to analyze

much of what they do under two

separate bodies of law, and are left with

regulatory uncertainty. As a result, they

recommended that the OIG conform safe

harbors to the statutory and regulatory

exceptions applicable under the Stark

provisions, thus protecting any payment

arrangement that meets an exception

under the Stark provisions. We intend

specifically to address this issue in the

final regulations that are being

developed in response to the September

1993 proposed rule.
Federal Register / Vol. 62, No. 237 / Wednesday, December 10, 1997 / Proposed Rules 65051

Physician Ownership of Hospitals

Since physician investment in

hospitals is expressly recognized under

the Stark provisions, a recommendation

was made for a companion safe harbor

for physicians and group practices that

hold ownership interests in hospitals to

which they refer.

ASCs, CORFs and Similar Entities

Commenters recommended expanded

safe harbors to cover ambulatory

surgical centers (ASCs) owned by a

group practice (even if not all members

of the group are surgeons), and for ASCs

that are owned in part by physicians

and in part by hospitals or other nonphysician investors, as long as the

physician’s return on investment is

based on the performance of the ASC as

a whole. A commenter also requested

protection for physician ownership in

other facilities where they practice, such

as comprehensive outpatient

rehabilitation facilities. We expect to

address these issues in the final

regulations being developed in response

to our earlier safe harbor proposed rule.

Services Provided by Federally-Funded

Community Health Centers

A safe harbor was suggested to allow

Federally-funded community health

centers to take advantage of

opportunities to improve their services

to disadvantaged patients, for example,

by arranging for discounted services

where the arrangement will produce a

substantial benefit to a medically

underserved population.

Continuing Education

One commenter recommended a safe

harbor delineating the circumstances

under which manufacturers,

commercial laboratories and other

providers can sponsor or provide

continuing education programs to

health care facilities and practitioners.

This commenter believed that many

educational opportunities may be

foregone by practitioners who, at the

request of the provider, may have to

notify other local practitioners about the

presentation to avoid the appearance of

impropriety. The commenter was

concerned that the OIG may consider a

presentation to a single hospital, for

example, as an inducement for Medicare

referrals.

Cataract Surgery-Related Prosthetic

Devices

A recommendation was made for a

safe harbor addressing the referral of

patients for eyeglasses, contact lenses

and intraocular lenses. A commenter

stated that eyeglasses and contact lenses

sold by optical stores, regardless of who

owns the establishment, are consumer

items that are subject to specific

controls by the Federal Trade

Commission, as well as by State

regulation and free market competition.

With respect to a safe harbor for the

provision of intraocular lenses during

cataract surgery, the commenter

indicated that patients during an

operation are not in a position to shop

elsewhere for these items, and the

selection of these lenses is based on

operative techniques and often cannot

be done prior to surgery.

New Managed Care Safe Harbors

A new safe harbor was suggested to

apply broadly to all Medicare and

Medicaid contracting managed care

plans that are in compliance with the

applicable requirements under

Medicare, and plans that are

participating in the Health Care

Financing Administration (HCFA)

managed care demonstrations. A

recommendation was also made to

establish comparable safe harbor

protection for managed care plans that

are licensed or regulated by HCFA or

State regulatory bodies, involving noncontracting organizations and their

activities involved in providing and

arranging care for Medicare

beneficiaries. Further, a

recommendation for new safe harbors

was also received that would protect

other managed care financial

relationships, such as (i) payment

arrangements between managed care

organizations and manufacturers that

relate to usage of the manufacturer’s

products by the managed care

organization’s enrollees and (ii)

protection for preferred provider

organizations that charge administrative

fees to providers.

Intercorporate Transfers

Commenters recommended that a new

safe harbor be created for integrated

delivery systems that would address

payments between related entities,

including, among others, parent

companies and wholly-owned

subsidiaries. This safe harbor would

serve to clarify permissible transfers of

‘‘remuneration’’ between and among

physicians, hospitals, health plans and

others who are delivering health care

through integrated delivery systems.

Offering Flat Rates for Outpatient

Surgery by Hospitals

With regard to outpatient surgeries, a

commenter stated that providers should

be able to charge Medicare patients in

the same fashion as other patients,

without fear of sanctions. As a result,

they recommended a new safe harbor

for flat fees for outpatient surgeries. The

commenter suggested that this would

enhance access to health services to the

extent that the beneficiary would have

a greater comfort level knowing the

coinsurance charge at the time a

procedure is scheduled rather than

dealing with uncertainty of not knowing

the precise amount of the coinsurance

obligation until after the procedure has

been billed.

Physician Retention

A new safe harbor was recommended

for all physician retention efforts by

hospitals, regardless of a hospital’s

location. The safe harbor would protect

payments or benefits offered by

hospitals and other entities to retain

physicians and other practitioners in the

service area.

Investments by Ambulatory Surgical

Center (ASC) Administrators and

Family Members

A commenter suggested a safe harbor

to protect investment interests by

certain non-practitioners who are

actively involved with the delivery of

health care services at an ASC in an

administrative or managerial capacity.

Since many ASCs are owned, in part, by

facility administrators who have a

vested interest in the success of the

ASC, it was believed that these

individuals should be allowed to invest

in ASCs and participate in any profits

generated by the facility at which they

work with the protection of a safe

harbor, much like surgeons would be

allowed to invest in the ASC even if

passive investors. The commenter also

believed that a safe harbor should allow

investment interests in ASCs to be held

by family members of those individuals

whose investment interests are

protected by the safe harbor so long as

those family members are not able to

make or influence referrals to the

facility. We expect to address this issue

in the OIG’s final regulations being

developed in response to our earlier safe

harbors proposal.

ASCs Located in Underserved Rural

Areas

To encourage efficient and less-costly

medical care delivery, it was

recommended that all investments in an

ASC in an area where there was

previously no ASC or hospital,

regardless of their source, should

receive protection as long as the

investments meet specific criteria set

forth in the proposed safe harbor for

investments in entities in rural areas.

(Proposed revisions to § 1001.952(a)(4)

were set forth in the OIG proposed
65052 Federal Register / Vol. 62, No. 237 / Wednesday, December 10, 1997 / Proposed Rules

rulemaking of September 21, 1993 (58

FR 49008).)

Loans

A commenter indicated that loans

between a provider and practitioner are

often the only available source of

necessary capital in a community, and

recommended protection for loans

between parties who may be in a

position to refer, recommend or arrange

for the referral or recommendation of

Medicare or Medicaid covered items or

services.

Investments

Although there is a safe harbor under

the anti-kickback statute for investment

interests, a commenter believed that it

expressly protects only payments in the

form of ‘‘return paid to investors’’ on

investments that comply with the safe

harbor’s requirement, but not expressly

the investments themselves. They

indicated that health care providers and

practitioners often enter into legitimate

business ventures in which the

investors are potential recipients of

referrals from the venture in which they

are investing. As a result, the

commenter recommended a new safe

harbor to protect legitimate investments

from the anti-kickback statute.

De Minimis Gifts

A commenter suggested a new safe

harbor addressing de minimis gifts to

beneficiaries for recommending a new

customer to the provider. For purposes

of this proposal, de minimis gifts would

be small tokens of a provider’s gratitude

given to customers and community

members who suggest the provider’s

services or products to other potential

customers, consistent with the Internal

Revenue Service’s definition on

limitation on all allowable business

gifts. No safe harbor protection would

be afforded where gifts, even if de

minimis, were made to physicians and

other practitioners in a position to

influence patients.

Physician/Provider Sponsored

Organizations

Commenters requested that a new safe

harbor be created for physician/provider

sponsored organizations (PSOs). The

proposed safe harbor would protect

payments to or by any provider,

provider sponsor or provider service

network for services to beneficiaries

enrolled by an eligible organization

under section 1876 of the Act in

accordance with a full-risk or partialrisk contract. The commenter suggested

that protection for PSOs would increase

patient access to health care services

and increase the health care options

available to program beneficiaries.

B. Proposed New OIG Special Fraud

Alerts

Limitation on use of Fraud Alerts

A recommendation was made to limit

the use of Special Fraud Alerts to

circumstances that raise concerns about

serious and clear violations, rather than

merely ‘‘questionable’’ practices.

Financial Arrangements Between

Hospitals and Hospital-Based

Physicians

A commenter stated that an increasing

number of hospital-based physician

agreements with hospitals compensate

physicians for less than the fair market

value of management and supervisory

services they provide to hospitals, or

require physicians to pay more than the

fair market value for certain services

provided by the hospital as a condition

for entering into or renewing contracts.

As a result, a Fraud Alert was

recommended to discuss financial

arrangements between hospitals and

hospital-based physicians. A second

commenter raised concern about the

appropriate compensation for hospitalbased physicians and physicians serving

as medical directors. They

recommended a new OIG Fraud Alert

addressing services considered integral

and not ‘‘incident to’’ physician

services, and the proper use of

nonphysician practitioners

accompanied by the appropriate billing

for their services.

Ambiguity in Billing Practices

A suggestion was made to provide

clear direction regarding covered and

non-covered services and appropriate

billing practices and, in conjunction

with section 231 of the HIPAA, define

the term ‘‘pattern of billing for services’’

that the provider knew or should have

known was not medically necessary.

The commenter indicated that any

Fraud Alert should specify that no

sanctions would be taken for a pattern

of billing for services considered to be

medically unnecessary until the

provider has been given written notice

of the problem and an opportunity to

desist from the billing practice.

Barring Demands by Medicare

Supplemental Carriers for Discounts

from Providers

Since Medigap carriers other than

Medicare SELECT plans continue to

seek discounts or waivers of copayment

amounts from providers, it was

recommended that the OIG clarify that

is improper for Medigap insurers (other

than Medicare SELECT in connection

with Part A services covered by existing

safe harbors) to seek discounts and

waivers of Medicare coinsurance or

deductible amounts.

Payment Arrangements Between

Hospice Providers and Nursing Homes

Concern was voiced over certain

compensation arrangements between

hospices and nursing facilities,

including skilled nursing facilities, that

suggested suspect incentive

arrangements that disguise referral fees

as payments for services to such nursing

facilities. A Fraud Alert was suggested

to address the fact that when a hospice

pays a nursing facility more than 95

percent of the Standard Medicaid Per

Diem Reimbursement Rate, such

arrangements may violate the antikickback statute.

Clinical Laboratory Personnel Within an

ESRD Facility

A commenter recommended an

amendment to the phlebotomy section

of the OIG Special Fraud Alert—

‘‘Arrangements for the Provision of

Clinical lab Services’’—that was issued

in October 1994. Under that section, a

clinical laboratory’s placement of a

phlebotomist in a physician’s office

does not in and of itself serve as an

inducement prohibited by the antikickback statute. However, the

commenter indicated that certain tasks

could implicate the statute if those

functions that benefit the physician are

performed by the phlebotomist. As a

result, they proposed that the OIG

highlight a similar practice of providing

a clinical laboratory employee, or

processor, to an ESRD facility on a fulltime basis to relieve the facility of these

duties.

Laboratory Contracting with Billing

Management Consultants

It was suggested that a Fraud Alert be

developed outlining the potential issues

related to contracting with billing

management consultants, the

appropriate relationship between the

facility and the consultants, and the

liability of all parties involved in the

contract.

Discounted Copayments and

Deductibles

In light of new civil money penalty

authority for Medicare providers who

offer incentives to induce Medicare

referrals, it was recommended that a

Fraud Alert be developed addressing

situations in which a copayment or

deductible can be discounted.
Federal Register / Vol. 62, No. 237 / Wednesday, December 10, 1997 / Proposed Rules 65053

Home Health Issues

With regard to the proper certification

of Medicare beneficiaries for home

health services, a recommendation was

made to develop a Fraud Alert defining

what is considered ‘‘home bound’’ and

what actions should be taken to ensure

that the beneficiary is appropriately

certified and is eligible for home health

services. The commenter also

recommended that a Fraud Alert

address home health agency procedures

related to contacting patients upon

discharge from the hospital, and claims

for home health visits that occur prior

to physician authorization for the visit.

Medicare as Secondary Payer

A commenter indicated that if

primary coverage is not identified,

Medicare may be billed inappropriately,

thus leading to allegations of fraudulent

billing. The commenter recommended a

new Fraud Alert setting forth the

appropriate process to determine

primary coverage, and the level of

diligence a facility must use to verify

primary coverage.

Hospice Care

A new Fraud Alert was recommended

outlining the appropriate method for

determining life expectancy to meet

hospice eligibility criteria, and the

responsibility if a patient is

subsequently found ineligible for

hospice benefits due to an incorrect

determination of life expectancy. It was

also suggested that the Fraud Alert

address billing issues associated with a

hospice patient who is transferred to a

hospital, and the instances when a

hospital should bill the hospice instead

of Medicare to avoid duplicate bills to

Medicare for the same patient.

Hospital Issues

It was suggested that problems have

occurred with PPS hospitals billing

Medicare for discharging a patient when

the patient was actually transferred to

another PPS hospital or unit, and that

the OIG develop a Fraud Alert outlining

instances in which a hospital may bill

Medicare for a patient discharge and

when the hospital must file a claim as

a transfer.

Value Added Services

A new Fraud Alert was recommended

to address concerns about vendors in

the food service industry offering ‘‘value

added services’’ to their institutional

customers. The commenter stated that

many of these practices, intended to

induce the initiation or maintenance of

a business relationship between parties,

raised concerns under the anti-kickback

statute since food service sold to health

care institutions is reimbursed in part

by Medicare and the State health care

programs.

Further public comments on the

proposals summarized above are not

being solicited at this time.

III. Solicitation of Additional New

Recommendations and Proposals

In accordance with the requirements

of section 205 of Public Law 104–191,

we are seeking additional

recommendations from affected

provider, practitioner, supplier and

beneficiary representatives regarding the

development of proposed or modified

safe harbor regulations and new Special

Fraud Alerts beyond those summarized

above.

Criteria for Modifying and Establishing

Safe Harbor Provisions

In accordance with the statute, we

will consider a number of factors in

reviewing proposals for new or

modified safe harbor provisions, such as

the extent to which the proposals would

effect an increase or decrease in—

• Access to health care services;

• The quality of care services;

• Patient freedom of choice among

health care providers;

• Competition among health care

providers;

• The cost to Federal health care

programs;

• The potential overutilization of the

health care services; and

• The ability of health care facilities

to provide services in medically

underserved areas or to medically

underserved populations.

In addition, we will also take into

consideration the existence (or

nonexistence) of any potential financial

benefit to health care professionals or

providers that may vary based on their

decisions of whether to (1) order a

health care item or service, or (2)

arrange for a referral of health care items

or services to a particular practitioner or

provider.

Criteria for Developing Special Fraud

Alerts

In determining whether to issue

additional Special Fraud Alerts, we will

also consider whether, and to what

extent, those practices that would be

identified in new Fraud Alerts may

result in any of the consequences set

forth above, and the volume and

frequency of the conduct that would be

identified in these Special Fraud Alerts.

A detailed explanation of justification

or empirical data supporting the

suggestion, and sent to the address

indicated above, would prove helpful in

our considering and drafting new or

modified safe harbor regulations and

Special Fraud Alerts.

Dated: December 1, 1997.

June Gibbs Brown,

Inspector General.

[FR Doc. 97–32150 Filed 12–9–97; 8:45 am]

BILLING CODE 4150–04–P

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 32

[CC Docket No. 97–212; FCC 97–355]

Uniform System of Accounts for

Interconnection

AGENCY: Federal Communications

Commission.

ACTION: Proposed rule.

SUMMARY: In this document, we propose

rules for the accounting treatment of

transactions related to interconnection

and shared infrastructure. Specifically,

we propose new Part 32 accounts and

subsidiary recordkeeping requirements

to record the revenues and expenses

related to providing and obtaining

interconnection. We tentatively

conclude that new accounts are not

necessary to record the revenues and

expenses associated with sharing

infrastructure.

DATES: Interested parties may file

comments on or before December 10,

1997, and reply comments on or before

January 26, 1998. Written comments by

the public on the proposed and/or

modified information collections are

due December 10, 1997. Written

comments must be submitted by the

Office of Management and Budget

(OMB) on the proposed and/or modified

information collections on or before

February 9, 1998.

ADDRESSES: Parties should send their

comments or reply comments to Office

of the Secretary, Federal

Communications Commission, 1919 M

Street, NW., Room 222, Washington, DC

20554. Parties should also send a paper

copy, and a copy on 3.5 inch diskette

formatted in an IBM compatible form

using, if possible, WordPerfect 5.1 for

Windows software, to Matthew Vitale of

the Common Carrier Bureau’s

Accounting and Audits Division, 2000 L

Street, NW., Room 200F, Washington,

DC 20554. Commenters should also

provide one copy of any documents

filed in this proceeding to the

Commission’s copy contractor,

International Transcription Service,

1231 20th Street, NW., Washington, DC

20036.