32060 Federal Register / Vol. 65, No. 99 / Monday, May 22, 2000 / Proposed Rules

one-half the maximum contaminant

level (MCL) as established under the

Safe Drinking Water Act;

• The Army must upgrade the

treatment system or pay any

incremental costs caused by

contamination from Schofield Barracks

at wells that already have a treatment

system in place;

• Conduct five year reviews with the

State of Hawaii and EPA.

The following actions were taken to

implement the remedy decision for

OU2:

• The Army installed air-stripper

treatment units on their four

contaminated municipal water supply

wells at Schofield and will continue to

operate the treatment system as long as

contaminants in the influent water are

above maximum contaminant levels

(MCLs) specified in the Safe Drinking

Water Act.

• The Army has sampled drinking

water wells, agricultural wells and

monitoring wells semi-annually

throughout the central plateau area of

Oahu since 1993 and will continue to

do so until such time as the Army, EPA

and HDOH agree that contaminant

levels throughout the plume are below

action levels.

• The groundwater contaminant

plume appears to be confined by a

system of dike impoundments and

natural attenuation. The EPA, HDOH

and the Army believe that it will not

impact any additional down-gradient

wells. Therefore, the contingency

remedy for additional wellhead

treatment is not expected to be needed.

• Institutional controls have been

implemented that will restrict the

placement of new drinking water wells

into the contaminant plume. The

Honolulu Board of Water Supply

controls the installation of drinking

water wells via a permit process. They

will require the installation of wellhead

treatment, paid for by the Army, on any

wells that are drilled into the plume

area.

OU4

The ROD for OU4, the landfill, was

signed by EPA on September 26, 1996.

The selected remedy included the

following actions:

• Access restrictions and site security

to limit human exposure to the landfill

contents, prevent trespassing, and

protect the integrity of the cap;

• Semi-annual ground water

monitoring to monitor the effectiveness

of the landfill site cap and determine

groundwater flow directions in the

vicinity of the landfill;

• Regrade the existing landfill cover;

• Remove Guinea grass from the

existing cover and revegetate to improve

future cap maintenance;

• Perform long-term maintenance of

the landfill cover;

• Maintain existing passive landfill

gas venting; and

• Install additional gas monitoring

points at the perimeter of the landfill.

The following actions were taken to

implement the remedy decision for

OU4:

• The Army installed chain-link fence

around the perimeter of the accessible

portions of the landfill as an access

restriction and has installed signs

warning of potential health risks. The

Former Landfill is part of a military

installation that has a guard stationed at

the entrances to monitor access to the

installation 24 hours per day.

• The Army completed regrading the

cover, installing nine new multi-level

gas probes, stabilizing the sideslopes,

and replacing and improving the

vegetative cover in June 1998.

• The Army has conducted semiannual groundwater monitoring and

quarterly gas probe monitoring since the

completion of the remedial action in

June 1998. The groundwater monitoring

is conducted as part of the OU2 work

and it shows that the groundwater

plume around the landfill is stable and

at low levels of TCE concentration. The

gas probe monitoring typically detects

methane in four out of the 27 gas probe

sampling points. The highest detection

during the February 2000 monitoring

event was 0.2 percent, which is well

below the acceptable limit of 5 percent.

On July 21, 1998, the Army, EPA and

HDOH, conducted a final inspection

and determined that the remedial action

had been successfully executed for all

OUs. EPA reclassified Schofield

Barracks to construction complete status

in September 1998.

Operation and Maintenance

The Army is responsible for

conducting long-term maintenance and

upkeep of the landfill cover and for

monitoring landfill gas, groundwater,

and drinking water wells, in accordance

with the approved Long-Term

Operation, Maintenance and Monitoring

Plans for OUs 2 and 4.

Five Year Reviews

CERCLA requires a five-year review of

all sites with hazardous substances

remaining above the health-based levels

for unrestricted use of the site. Since the

cleanup of the site utilized containment

of hazardous materials within the

landfill and wellhead treatment for

drinking water, the five-year review

process will be used to ensure that

human health and the environment

remain protected in the future. The first

five-year review is scheduled for the

year 2002.

Community Involvement

The Army published its final

Community Relations Plan on January

31, 1997, after interviews with local

residents and officials. An information

repository was established at the

Wahiawa Public Library and all reports

and fact sheets were sent to the

repository as they were completed.

The Army conducted public meetings

prior to completing each of the four

Records of Decision, and the public had

no negative comments about any of the

actions at Schofield.

Applicable Deletion Criteria and State

Concurrence

EPA has determined that all

appropriate responses under CERCLA at

Schofield Army Barracks have been

completed, and that no further CERCLA

response is appropriate to protect

human health and the environment. The

Hawaii Department of Health concurred

with the proposed deletion of the site

from the NPL in a letter dated March 13,

2000. Therefore, EPA proposes to delete

the site from the NPL. Documents

supporting this action are available from

the docket at the Region 9 office and in

the Army’s docket on Oahu.

Dated: April 25, 2000.

Felicia Marcus,

Regional Administrator, Region IX.

[FR Doc. 00–12520 Filed 5–19–00; 8:45 am]

BILLING CODE 6560–50–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of Inspector General

42 CFR Part 1001

RIN 0991–AB05

Medicare and State Health Care

Programs: Fraud and Abuse;

Ambulance Restocking Safe Harbor

Under the Anti-Kickback Statute

AGENCY: Office of Inspector General

(OIG), HHS.

ACTION: Notice of proposed rulemaking.

SUMMARY: This proposed rule would set

forth a new safe harbor, as authorized

under section 14 of the Medicare and

Medicaid Patient and Program

Protection Act of 1987, to protect certain

arrangements involving hospitals that

replenish drugs and medical supplies

used by ambulance providers when

Federal Register / Vol. 65, No. 99 / Monday, May 22, 2000 / Proposed Rules 32061

1 56 FR 35952 (July 29, 1991); 61 FR 2122

(January 25, 1996); 64 FR 63518 (November 19,

1999); and 64 FR 63504 (November 19, 1999).

2OIG Advisory opinion 98–7 (June 11, 1998); OIG

Advisory Opinion 98–13 (September 30, 1998); and

OIG Advisory Opinion 98–14 (October 28, 1998).

transporting emergency patients to the

hospitals.

DATES: To assure consideration, public

comments must be delivered to the

address provided below by no later than

5 p.m. on July 21, 2000.

ADDRESSES: Please mail or deliver your

written comments to the following

address: Department of Health and

Human Services, Office of Inspector

General, 330 Independence Avenue,

SW, Room 5246, Attention: OIG–62–P,

Washington, DC 20201.

Because of staffing and resource

limitations, we cannot accept comments

by facsimile (FAX) transmission. In

commenting, please refer to file OIG–

62–P.

FOR FURTHER INFORMATION CONTACT:

Vicki L. Robinson, Senior Counsel,

Office of Counsel to the Inspector

General, (202) 619–0335.

SUPPLEMENTARY INFORMATION: 

I. Background

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

the referral of business reimbursable

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

five years. Violations of the antikickback statute may also result in the

imposition of a civil money penalty

(CMP) under section 1128A(a)(7) of the

Act (42 U.S.C. 1320a–7a(a)(7)) or

program exclusion under section

1128(b)(7) of the Act (42 U.S.C. 1320a–

7(b)(7)).

The types of remuneration covered

specifically include kickbacks, bribes

and rebates, whether made directly or

indirectly, overtly or covertly, in cash or

in kind. In addition, prohibited conduct

includes not only the payment of

remuneration intended to induce

referrals of patients, but also the

payment of remuneration intended to

induce the purchasing, leasing or

ordering of any good, facility, service or

item reimbursable by any Federal or

State health care program.

Establishing the Original Safe Harbors

Since the statute on its face is so

broad, concern had been expressed that

some relatively innocuous commercial

arrangements were technically covered

by the statute and therefore were subject

to criminal prosecution. As a response

to the above concern, section 14 of the

Medicare and Medicaid Patient and

Program Protection Act of 1987, Public

Law 100–93, specifically required the

development and promulgation of

regulations, the so-called ‘‘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. Beginning in

July 29, 1991, we have published in the

Federal Register a series of final

regulations establishing ‘‘safe harbors’’

in various areas.1 These 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.

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,

the CMP provision for anti-kickback

violations or program exclusion

authority related to kickbacks. In giving

the Department the authority to protect

certain arrangements and payment

practices under the anti-kickback

statute, Congress intended the safe

harbor regulations to be evolving rules

that would be updated periodically to

reflect changing business practices and

technologies in the health care industry.

OIG Advisory Opinions on Restocking

Ambulance Supplies

The OIG has issued four advisory

opinions regarding arrangements

between hospitals and other facilities

providing emergency medical supplies,

i.e., ‘‘receiving facilities’’ and

ambulance companies, under which the

receiving facilities replenish

ambulances with drugs and medical

supplies used during the transport of

emergency patients to the receiving

facilities. In many of these

arrangements, the drugs and supplies

are replenished without charge to the

ambulance company.

In OIG Advisory Opinion 97–6

(October 8, 1997), we responded to a

request for an advisory opinion

involving an ambulance replenishing

arrangement that presented a specific

set of facts clearly implicating the antikickback statute. The arrangement, as

presented in the facts certified by the

requesting party, contained no

appropriate safeguards against fraud and

abuse of the Federal health care

programs and their beneficiaries.

Accordingly, we concluded that the

arrangement potentially violated the

anti-kickback statute.

Subsequently, in 1998, we received

several additional advisory opinion

requests that involved ambulance

replenishing arrangements, and issued

three additional advisory opinions

approving ambulance replenishing

arrangements.2 The facts of those three

arrangements differed significantly from

the facts that led to OIG Advisory

Opinion 97–6. Specifically, the latter

three opinions involved ambulance

replenishing programs conducted in

accordance with comprehensive,

coordinated emergency medical

delivery systems involving all of an

area’s ambulance providers and

hospitals (as well as other components

of the emergency medical system, such

as physicians and local government

officials). The OIG approved the three

arrangements (with the limited

exception of a portion of one of the

three programs), persuaded that the

arrangements posed little risk of Federal

health care program fraud or abuse and

that the arrangements promoted

comprehensive and coordinated efforts

to improve emergency medical care.

Since the release of OIG Advisory

Opinion 98–14 in October 1998, the OIG

has received no further advisory

opinion requests on the topic of

ambulance replenishing and few

informal follow-up inquiries regarding

these arrangements.

II. Provisions of the Proposed Rule

The OIG believes that, in general, the

ambulance and hospital industries

understand the distinction between the

first unfavorable advisory opinion and

the subsequent three favorable opinions

and are generally able to assess and

structure arrangements accordingly.

However, the OIG is aware of anecdotal

reports that some receiving facilities are

curbing or eliminating ambulance

replenishing programs in order to cut

emergency room costs, while other

receiving facilities feel pressured to

participate in ambulance replenishment

arrangements. Some receiving facilities

would like to implement or continue

operating replenishing programs, but are

concerned about possible liability under

the anti-kickback statute.

We continue to believe that properly

structured replenishing arrangements

serve a significant public interest by

providing a means of ensuring that

ambulances are fully stocked with

current medications, sanitary linens and

32062 Federal Register / Vol. 65, No. 99 / Monday, May 22, 2000 / Proposed Rules

3See, e.g., Emergency Medical Services Systems

Act of 1973 (EMSSA), Public Law 93–154

(providing Federal funding for the development of

regional Emergency Medical Services (EMS)

systems at the State, regional, and local levels, and

defining ‘‘emergency medical services system’’ as

‘‘a system which provides for the arrangement of

personnel, facilities and equipment for the effective

and coordinated delivery in an appropriate

geographical area of health care services under

emergency conditions * * * and which is

administered by a public or nonprofit private entity

which has the authority and the resources to

provide effective administration of the system.’’);

Highway Safety Act of 1966, Public Law 89–594

(establishing an EMS program in the Department of

Transportation); Emergency Medical Services for

Children Program, under the Public Health Act,

Public Law 98–555 (providing funds for enhancing

pediatric EMS); and Trauma Care Systems Planning

and Development Act of 1990, Public Law 101–590.

4 15 U.S.C. 13(c) exception to the RobinsonPatman Act (15 U.S.C. 13(a)–(f)). Inquiries as to the

applicability of, or compliance with, the Non-Profit

Institutions Act or the Robinson-Patman Act should

be directed to the Federal Trade Commission.

appropriate supplies, and that those

supplies are compatible with equipment

used in local emergency rooms so as to

expedite the transfer of critically ill or

injured patients to emergency room

systems. Such replenishing

arrangements are consistent with

Federal policy established over the past

25 years.3

In an effort to further assure those

providers engaged in innocuous and

beneficial replenishing arrangements,

we are proposing a new safe harbor

under § 1001.952 of our regulations to

protect certain arrangements between

receiving facilities (including hospitals)

and ambulance companies under which

the receiving facilities replenish

ambulances with drugs and medical

supplies used during the transport of

emergency patients to the receiving

facilities. Under this proposed rule, we

would provide safe harbor protection for

ambulance replenishing arrangements

that satisfy all of the conditions in one

of two categories established by the safe

harbor. Both categories pertain only to

emergency ambulance services; the safe

harbor would not protect replenishing

of ambulance supplies, linens or

medications following routine

ambulance transports.

Replenishing Arrangements Where

Ambulance Provider Pays Receiving

Facility Fair Market Value

The first new proposed safe harbor

would protect replenishing

arrangements where an ambulance

provider pays the receiving facility fair

market value, based on an arms-length

transaction, for replenished drugs or

supplies (including linens) used in

connection with the transport of an

emergency patient. Payment would not

need to be made at the time of the

replenishing, provided commercially

reasonable and appropriate payment

arrangements have been made in

advance. For linens, an exchange of a

comparable quantity of laundered linens

for soiled linens would be considered

fair market value, notwithstanding any

economic value attributable to the

laundering of linens by receiving

facilities, which often have specialized

laundering equipment needed for

compliance with sanitation

requirements. A non-profit receiving

facility would be protected under this

safe harbor if it sells replenished drugs

or medical supplies to a non-profit

ambulance provider at cost in order to

comply with the Non-Profit Institutions

Act.4

Remuneration in the Form of

Contemporaneous Replenishing of

Drugs or Medical Supplies

The second proposed safe harbor

would protect remuneration in the form

of contemporaneous replenishing of

drugs or medical supplies (including

linens) used during an emergency

transport of a patient to the receiving

facility, even if the replenishing is for

free or at reduced prices. We are

proposing that the following seven

conditions be met in order to qualify for

protection under this safe harbor:

(1) Receiving facilities must provide

replenishing on an equal basis for all

ambulance providers who bring

emergency patients to the receiving

facility. This condition is intended to

prevent receiving facilities from

inappropriately using replenishing to

attract or reward high referring

ambulance providers.

(2) The replenishing arrangement

must be part of a comprehensive and

coordinated effort to improve the EMS

delivery system in the relevant service

area and must be open to all emergency

ambulance providers and receiving

facilities operating in the service area. It

must be implemented with the

participation of, and monitored by, a

regional EMS Council or functionally

similar entity, organization or

association (the Oversight Entity). The

Oversight Entity must be a non-profit

entity composed of representatives of a

broad array of participants in a service

area’s emergency medical system, such

as hospitals, ambulance providers,

emergency room physicians and nurses,

public safety organizations, paramedics,

local educational institutions and

community residents. The involvement

of a wide range of representatives of the

local EMS community provides

substantial assurance that the

replenishment arrangement is intended

to benefit the local community, rather

than a single provider or group of

providers. Participation in the Oversight

Entity should be open to all interested

parties in the service area on equal

terms and conditions, i.e., the Oversight

Entity cannot be composed solely of

representatives of a single health

system. Typically, Oversight Entities

will engage in the following types of

activities:

—Standardization of EMS practices and

equipment;

—Education and training for prehospital care providers;

—Ongoing evaluation and improvement

of EMS capabilities in the service

area;

—Public information campaigns; and

—Other activities designed to promote

EMS care for the service area.

We recognize that the size,

composition, structure and scope of

activities of Oversight Entities may

necessarily vary depending on the size

and resources of the particular service

area. We would expect, for example, an

Oversight Entity in a small rural area

with one hospital, a few physicians and

one ambulance provider to look and

operate differently than one in a densely

populated urban area with several

hospitals, a number of transport

providers and diverse physicians,

teaching facilities, Government agencies

and the like. Oversight Entities should

be part of a comprehensive and

coordinated regional EMS system

appropriate to the size and resources of

the service area. We are not specifying

any particular structure or legal form for

the Oversight Entity; it must simply be

functionally similar to a regional EMS

Counsel. The participants in the

Oversight Entity should be

representative of the service area’s EMS

system. We are specifically soliciting

comments on our proposal that safe

harbored replenishing arrangements

must be a part of a comprehensive and

consolidated regional EMS system.

(3) The replenishing arrangement

must be memorialized in writing,

whether through a contract signed

under the auspices of the Oversight

Entity by all participating ambulance

providers and receiving facilities or by

a generally applicable plan or protocol

promulgated or approved by the

Oversight Entity. The replenishing

arrangement must in practice comport

with the terms of the written

documentation.

(4) The receiving facility must not bill

any Federal health care program or

Federal program beneficiary for the

replenished drugs or supplies, or write

off such drugs or supplies as bad debt.

The purpose of this requirement is to

Federal Register / Vol. 65, No. 99 / Monday, May 22, 2000 / Proposed Rules 32063

prevent double payments by Medicare,

which pays hospitals under Part A

(through fiscal intermediaries), but

which typically pays ambulance

providers for drugs and supplies used

during emergency transports under Part

B (through carriers).

(5) In order to prevent ‘‘double

dipping,’’ ambulance providers may not

bill any Federal health care program or

Federal beneficiary separately for the

replenished drugs or supplies.

(6) The receiving facility and the

ambulance provider must maintain

records of the replenished drugs or

supplies and make those records

available to the Secretary upon request.

(7) The receiving facility and

ambulance provider must otherwise

comply with all Federal, State and local

laws regulating emergency medical care

and the provision of drugs and medical

supplies, including laws relating to the

handling of controlled substances such

as morphine.

Nothing in this preamble or the

proposed regulations is intended to

express any view as to the appropriate

billing of the Federal health care

programs for supplies used during

emergency transport services. Parties

seeking to comply with these proposed

safe harbors would still need to comply

with all relevant billing and claims

filing rules. The fifth and sixth

conditions described above for the

second proposed safe harbor merely set

forth criteria for determining whether a

particular arrangement qualifies for safe

harbor protection under the antikickback statute; the conditions do not

purport to establish any reimbursement

rule. Questions regarding

reimbursement under the Medicare and

Medicaid programs should be addressed

to the Health Care Financing

Administration or the party’s relevant

fiscal intermediary or carrier.

As with the existing safe harbor

provisions currently codified in

§ 1001.952, compliance with these

proposed safe harbors would be

voluntary. Failure to fit into one of these

safe harbors would not mean that an

ambulance replenishment arrangement

is illegal. Rather, it would simply mean

that the arrangement would need to be

evaluated on a case-by-case basis.

Meeting the Criteria for Establishing

New Safe Harbors

Section 205 of the Health Insurance

Portability and Accountability Act,

Public Law 104–191, established certain

criteria that the Secretary may consider

when modifying or establishing safe

harbors to the anti-kickback statute. We

indicated our intent to consider these

criteria in evaluating proposals for new

safe harbors in our Notice of Intent to

Develop Regulations (61 FR 69061;

December 31, 1996). We have

considered these criteria in developing

this proposed rulemaking, and we

believe, for the reasons described above,

that the proposed safe harbor for certain

ambulance replenishing arrangements is

likely to: (l) Increase or have no effect

on access for needy patients to health

care services; (2) increase the quality of

health care services for needy patients;

(3) have little or no effect on the cost of

Federal health care programs; (4) have

little or no effect on competition; and (5)

have little or no effect on the quantity

of services provided in underserved

areas. We further believe the proposed

safe harbor contains safeguards that

limit the potential for overutilization

and assure that patients retain their

freedom of choice of service providers.

III. Regulatory Impact Statement

Executive Order 12866, the Unfunded

Mandates Reform Act, Executive Order

13132, and the Regulatory Flexibility

Act

The Office of Management and Budget

(OMB) has reviewed this proposed rule

in accordance with the provisions of

Executive Order 12866 and the

Regulatory Flexibility Act (5 U.S.C. 601-

612), and has determined that it does

not meet the criteria for a significant

regulatory action. Executive Order

12866 directs agencies to assess all costs

and benefits of available regulatory

alternatives and, when rulemaking is

necessary, to select regulatory

approaches that maximize net benefits,

including potential economic,

environmental, public health, safety

distributive and equity effects. Section

202 of the Unfunded Mandates Reform

Act, Public Law 104–4, requires that

agencies prepare an assessment of

anticipated costs and benefits on any

rulemaking that may result in an

expenditure by State, local or tribal

Government, or by the private sector of

$100 million or more in any given year.

Further, Executive Order 13132,

Federalism, requires agencies to

determine if a rule will have a

significant affect on States, on their

relationship with the Federal

Government, and on the distribution of

power and responsibility among the

various levels of government.

In addition, under the Small Business

Enforcement Act (SBEA) of 1996, if a

rule has a significant economic effect on

a substantial number of small

businesses, the Secretary must

specifically consider the economic

effect of a rule on small business entities

and analyze regulatory options that

could lessen the impact of the rule. In

addition, under the Regulatory

Flexibility Act, if a rule has a significant

economic effect on a substantial number

of small businesses, the Secretary must

specifically consider the economic

effect of a rule on small business entities

and analyze regulatory options that

could lessen the impact of the rule.

Executive Order 12866 requires that

all regulations reflect consideration of

alternatives, costs, benefits, incentives,

equity and available information.

Regulations must meet certain

standards, such as avoiding unnecessary

burden. We believe that this proposed

rule would have no significant

economic impact. The proposed safe

harbor provisions set forth in this

rulemaking are designed to permit

individuals and entities to freely engage

in business practices and arrangements

that encourage competition, innovation

and economy. As indicated above, in

doing so, these regulations impose no

requirements on any party. 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 actions under the antikickback statute. We believe that any

aggregate economic effect of these safe

harbor regulations would be minimal

and would impact only those limited

few who engage in prohibited behavior

in violation of the statute. As such, we

believe that the aggregate economic

impact of these proposed regulations is

minimal and would have no effect on

the economy or on Federal or State

expenditures

Additionally, in accordance with the

Unfunded Mandates Reform Act of

1995, we believe that there are no

significant costs associated with these

proposed safe harbor guidelines that

would impose any mandates on State,

local or tribal governments, or the

private sector that will result in an

expenditure of $100 million or more in

any given year. Further, in reviewing

this rule under the threshold criteria of

Executive Order 13132, Federalism, we

have determined that this rule would

not significantly affect the rights, roles

and responsibilities of States, and that a

full analysis under these Acts are not

necessary.

Further, in accordance with the

Regulatory Flexibility Act (RFA) of

1980, and the Small Business

Regulatory Enforcement Act of 1996,

which amended the RFA, we are

required to determine if this rule will

have a significant economic effect on a

substantial number of small entities

and, if so, to identify regulatory options

that could lessen the impact. While

32064 Federal Register / Vol. 65, No. 99 / Monday, May 22, 2000 / Proposed Rules

these safe harbor provisions may have

an impact on small entities, we believe

that the aggregate economic impact of

this rulemaking would be minimal,

since it is the nature of the violation and

not the size of the entity that will result

in a violation of the anti-kickback

statute. Since the vast majority of

individuals and entities potentially

affected by these regulations do not

engage in prohibited arrangements,

schemes or practices in violation of the

law, we believe that these proposed

regulations would not have a significant

economic impact on a number of small

business entities, and that a regulatory

flexibility analysis is not required for

this rulemaking.

Paperwork Reduction Act

In accordance with section

3506(c)(2)(A) of the Paperwork

Reduction Act (PRA) of 1995, we are

required to solicit public comments, and

receive final OMB approval, on any

information collection requirements set

forth in rulemaking. While compliance

with the provisions in this safe harbor

rule would be voluntary, proposed

§ 1001.952(v)(3) contains information

collection requirements that would

require approval by OMB. As such, we

are required to solicit public comments

under section 3506(c)(2)(A) of the PRA

on these requirements. Specifically, in

order to qualify for safe harbor

protection for ambulance restocking

arrangements under § 1001.952(v)(3),

the regulations would require that

replenishing agreements be set forth in

writing in the form of (1) a contract

signed under the auspices of the

oversight entity by all participating

ambulance providers and receiving

facilities or (2) a generally applicable

plan or protocol promulgated or

approved by the oversight entity. There

is no obligation to submit these

agreements to the Secretary, however, in

order to achieve initial compliance with

the safe harbor. In addition, to qualify

for safe harbor protection for ambulance

restocking arrangements under

§ 1001.952(v)(3), the receiving facility

and the ambulance provider must

maintain records of the replenished

drugs and medical supplies (including

linens) and make those records available

to the Secretary promptly upon request.

However, as indicated above, the safe

harbor does not require any submission

of reports, data collection or other

documents in order to be in compliance

with the anti-kickback statute.

In accordance with the PRA

requirements, we are inviting comments

on (1) whether the proposed collection

of information is necessary for the

proper performance of the functions of

the agency, including whether the

information will have practical utility;

(2) the accuracy of the estimate of the

burden of the proposed collection of

information; (3) ways to enhance the

quality, utility and clarity of the

information collected; and (4) ways to

minimize the burden of the collection of

information on parties, including

through the use of automated collection

techniques or other forms of information

technology. As part of the OMB

approval for the collection of

information contained in this rule, we

are soliciting public comments on this

requirement, thereby initiating the

normal PRA clearance.

Title: Ambulance Restocking Safe

Harbor Under the Anti-Kickback

Statute.

Summary of the collection of

information: Proposed § 1001.952(v)

would set forth a new statutory

exception to the anti-kickback statute

that covers any gift or transfer of drugs

or medical supplies (including linens)

by a hospital or other receiving facility

to an ambulance provider for the

purpose of replenishing comparable

drugs or medical supplies (including

linens) used by the ambulance provider

in connection with the transport of an

emergency patient to the hospital or

other receiving facility. Safe harbors do

not create any affirmative obligation on

any individuals or entities. Seeking

protection under these safe harbor

provisions is purely voluntary.

The aggregate information burden for

the information collection requirements

contained in this proposed rulemaking

is set forth below.

Respondents: In accordance with

proposed § 1001.952(v), the respondents

for the collection of information

described in these regulations are

parties involved in written agreements

between (1) a hospital or other receiving

facility that replenishes drugs and

medical supplies, and (2) ambulance

providers who bring emergency patients

to the receiving facility.

Estimated number of respondents:

The safe harbor being proposed in

§ 1001.952(v) would protect those

restocking arrangements between

receiving facilities that replenish drugs

and medical supplies on an equal basis

to all ambulance providers who

transport their emergency patients to the

receiving facility. Virtually all such

replenishing arrangements already are

memorialized in written contracts as a

matter of prudent business practice,

irrespective of the existence of the

proposed safe harbor. We believe that

few, if any, parties will enter into

written arrangements specifically for the

purposes of safe harbor protection.

Accordingly, we estimate that the

number of parties entering into written

agreements to qualify for safe harbor

protection will be negligible.

Estimated number of responses per

respondent: None.

Estimated total annual burden on

respondents: We believe that the burden

of preparing written agreements and the

aggregate information burden for the

information collection requirements

contained in this proposed rulemaking

would be minimal. As indicated above,

in most, if not all, cases the parties

already have written agreements as part

of the parties’ replenishing

arrangements, independent of the safe

harbor requirements. Accordingly, any

burden imposed by these proposed

regulations would impose no burden on

such parties.

Comments on this information

collection activity should be sent to:

Allison Herron Eydt, OIG Desk Officer,

Office of Management and Budget,

Room 10235, New Executive Office

Building, 725 17th Street. NW,

Washington, DC 20053, FAX: (202) 395–

6974.

Comments on these paperwork

reduction requirements may be

submitted to the above-cited individual

within 60 days following the Federal

Register publication of this proposed

rule.

IV. Public Inspection of Comments and

Response to Comments

Comments will be available for public

inspection June 5, 2000 in Room 5518,

Office of Counsel to the Inspector

General, at 330 Independence Avenue,

SW, Washington, DC on Monday

through Friday of each week (Federal

holidays excepted) between the hours of

9 a.m. and 4 p.m., (202) 619–0089.

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 will respond to the

comments in the preamble of the final

rule.

List of Subjects in 42 CFR Part 1001

Administrative practice and

procedure, Fraud, Grant programs—

health, Health facilities, Health

professions, Maternal and child health,

Medicaid, Medicare.

Accordingly, 42 CFR part 1001 would

be amended as set forth below:

Federal Register / Vol. 65, No. 99 / Monday, May 22, 2000 / Proposed Rules 32065

PART 1001—[AMENDED]

1. The authority citation for part 1001

would continue to read as follows:

Authority: 42 U.S.C. 1302, 1320a–7,

1320a–7b, 1395u(h), 1395u(j), 1395u(k),

1395y(d), 1395y(e), 1395cc(b)(2)(D), (E) and

(F), and 1395hh; and sec. 2455, Pub.L. 103–

355, 108 Stat. 3327 (31 U.S.C. 6101 note).

2. Section 1001.952 would be

amended by republishing the

introductory text and by adding a new

paragraph (v) to read as follows:

§ 1001.952 Exceptions

The following payment practices shall

not be treated as a criminal offense

under section 1128B of the Act and

shall not serve as the basis for an

exclusion:

* * * * *

(v) Ambulance restocking. (1) As used

in section 1128B of the Act,

‘‘remuneration’’ does not include any

gift or transfer of drugs or medical

supplies (including linens) by a hospital

or other receiving facility to an

ambulance provider for the purpose of

replenishing comparable drugs or

medical supplies (including linens)

used by the ambulance provider in

connection with the transport of an

emergency patient to the hospital or

other receiving facility if all of the

applicable standards in either paragraph

(v)(2) or (v )(3) of this section are

satisfied.

(2)(i) Except as otherwise provided in

paragraph (v)(2)(ii) of this section, the

ambulance provider pays the receiving

facility fair market value, based on an

arms-length transaction, for the

replenished drugs or medical supplies

(including linens). A non-profit

receiving facility will be deemed to

meet this standard if it sells replenished

drugs or medical supplies to a nonprofit ambulance provider at cost in

order to comply with the Non-Profit

Institutions Act (15 U.S.C. 13(c)),

exception to the Robinson-Patman Act

(15 U.S.C. 3(a)–(f)).

(ii) If payment is not made

contemporaneously with the

replenishing of the drugs or medical

supplies (including linens), the

receiving facility and the ambulance

provider make commercially reasonable

payment arrangements in advance.

(3)(i) The receiving facility

replenishes drugs and medical supplies

(including linens) on an equal basis for

all ambulance providers who bring

emergency patients to the receiving

facility.

(ii) The replenishing arrangement

must be implemented with the

participation of, and monitored by, an

oversight entity (as defined in paragraph

(v)(4)(ii) of this section) as part of a

comprehensive and coordinated

regional emergency medical system

appropriate to the size and resources of

the service area and must be open and

available to all emergency ambulance

providers and receiving facilities in the

service area.

(iii) The replenishing arrangement

must be memorialized in writing. The

writing may be in the form of—

(A) A contract signed under the

auspices of the oversight entity by all

participating ambulance providers and

receiving facilities or

(B) A generally applicable plan or

protocol promulgated or approved by

the oversight entity.

(iv) The receiving facility refrains

from billing any Federal health care

program or Federal health care program

beneficiary for the replenished drugs or

medical supplies (including linens) and

does not write off the cost of such drugs

or medical supplies (including linens)

as bad debt.

(v) The ambulance provider refrains

from billing any Federal health care

program or Federal health care program

beneficiary separately for the

replenished drugs or medical supplies

(including linens).

(vi) The receiving facility and the

ambulance provider maintain records of

the replenished drugs and medical

supplies (including linens) and make

those records available to the Secretary

promptly upon request.

(vii) The receiving facility and the

ambulance provider otherwise comply

with all Federal, State and local laws

regulating emergency medical care and

the provision of drugs and medical

supplies, including, but not limited to,

laws relating to the handling of

controlled substances.

(4) For purposes of paragraph (v)(3) of

this section—

(i) A ‘‘receiving facility’’ is a hospital

or other facility that provides emergency

medical services; and

(ii) An ‘‘oversight entity’’ is a regional

emergency medical services council or

functionally similar entity, association

or organization that—

(A) Is described in section 501(c)(3) or

501(c)(4) of the Internal Revenue Code

and exempt from taxation under section

501(a) of that Code;

(B) Includes, or is composed of,

representatives of a broad array of

participants in a service area’s

emergency medical system (e.g.,

hospitals, ambulance providers,

emergency room physicians,

paramedics, public safety organizations,

local educational institutions and

community residents);

(C) Is open to all interested parties in

the service area on equal terms and

conditions; and

(D) Has as its mission the

improvement of the emergency medical

services delivery system in the relevant

service area.

Dated: November 2, 1999.

June Gibbs Brown,

Inspector General.

Approved: November 18, 1999.

Donna E. Shalala,

Secretary.

[FR Doc. 00–12697 Filed 5–19–00; 8:45 am]

BILLING CODE 4150–04–P

DEPARTMENT OF DEFENSE

48 CFR Parts 209 and 223

[DFARS Case 2000–D004]

Defense Federal Acquisition

Regulation Supplement; Pollution

Control and Clean Air and Water

AGENCY: Department of Defense (DoD).

ACTION: Proposed rule with request for

comments.

SUMMARY: The Acting Director of

Defense Procurement is proposing to

amend the Defense Federal Acquisition

Regulation Supplement (DFARS) to

revise and relocate policy on the level

of approval required to except a contract

from certain restrictions of the Clean Air

Act or the Clean Water Act. The policy

is moved from the Pollution Control and

Clean Air and Water subpart to the

Debarment, Suspension, and

Ineligibility subpart of the DFARS,

because the Federal Acquisition

Regulation (FAR) subpart on Pollution

Control and Clean Air and Water has

been removed.

DATES: Comments on the proposed rule

should be submitted in writing to the

address shown below on or before July

21, 2000, to be considered in the

formation of the final rule.

ADDRESSES: Interested parties should

submit written comments on the

proposed rule to: Defense Acquisition

Regulations Council, Attn: Ms. Sandra

G. Haberlin, PDUSD (AT&L) DP (DAR),

IMD 3D139, 3062 Defense Pentagon,

Washington, DC 20301–3062. Telefax

(703) 602–0350.

E-mail comments submitted via the

Internet should be addressed to:

dfars@acq.osd.mil

Please cite DFARS Case 2000–D004 in

all correspondence related to this

proposed rule. E-mail correspondence

should cite DFARS Case 2000–D004 in

the subject line.