7350 Federal Register / Vol. 62, No. 33 / Wednesday, February 19, 1997 / Rules and Regulations

List of Subjects in 14 CFR Part 73

Airspace, Navigation (air).

Adoption of the Amendment

In consideration of the foregoing, the

Federal Aviation Administration

amends 14 CFR part 73 as follows:

PART 73—[AMENDED]

1. The authority citation for part 73

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40103, 40113,

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–

1963 Comp., p. 389; 14 CFR 11.69.

§ 73.43 [Amended]

R–4305 Lake Superior, MN [Amended]

By removing ‘‘Time of Designation.

Intermittent by NOTAM, 12 hours in

advance,’’ and substituting ‘‘Time of

designation. Intermittent by NOTAM, 4

hours in advance.’’

Issued in Washington, DC, on February 7,

1997.

Jeff Griffith,

Program Director for Air Traffic Airspace

Management.

[FR Doc. 97–4068 Filed 2–18–97; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of Inspector General

42 CFR Part 1008

RIN 0991–AA85

Medicare and State Health Care

Programs: Fraud and Abuse; Issuance

of Advisory Opinions by the OIG

AGENCY: Office of Inspector General

(OIG), HHS

ACTION: Interim final rule with comment

period.

SUMMARY: In accordance with section

205 of the Health Insurance Portability

and Accountability Act of 1996, this

final rule establishes a new part 1008 in

42 CFR chapter V to address the new

OIG advisory opinion process.

Specifically, these regulations set forth

the specific procedures by which the

Office of Inspector General, in

consultation with the Department of

Justice, will issue advisory opinions to

outside parties regarding the

interpretation and applicability of

certain statutes relating to the Medicare

and State health care programs.

DATES: Effective Date: This rule is

effective on February 21, 1997.

Comment Period: To assure

consideration, public comments must be

delivered to the first address provided

under ADDRESSES by no later than 5 p.m.

on April 21, 1997. Comments will be

available for public inspection March 5,

1997 at the second address provided

under ADDRESSES on Monday through

Friday of each week from 8:00 a.m. to

4:30 p.m., (202) 619–0089.

ADDRESSES: Please mail or deliver your

written comments to the following

address: Office of Inspector General,

Department of Health and Human

Services, Attention: OIG–10–IFC, Room

5246, Cohen Building, 330

Independence Avenue, SW.,

Washington, DC 20201.

Because of staffing and resource

limitations, we cannot accept comments

by facsimile (FAX) transmission. In

commenting, please refer to file code

OIG–10–IFC.

FOR FURTHER INFORMATION CONTACT: Joel

Schaer, (202) 619–0089, OIG

Regulations Officer.

SUPPLEMENTARY INFORMATION:

I. Background

A. The Medicare Anti-Kickback Statute

Section 1128B(b) of the Social

Security 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

Medicare 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.

This provision is quite broad. 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 Medicare 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.

B. Safe Harbors and Fraud Alerts

As a response to the above concern,

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 Medicare

and State health care programs, would

not be treated as criminal offenses under

the anti-kickback statute (section

1128B(b) of the Social Security Act; 42

U.S.C. 1320b(b)) and would not serve as

a basis for a program exclusion under

section 1128(b)(7) of the Social Security

Act; 42 U.S.C. 1320a–7(b)(7).

The OIG safe harbor provisions have

been developed to permit individuals

and entities to freely engage in business

practices and arrangements that

encourage competition, innovation and

economy. 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 antikickback statute or program exclusion

authority. The 13 final safe harbor

provisions, which specify practices

which are expressly made legal, are

codified at 42 CFR 1001.952.

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. Eight

individual Special Fraud Alerts were

published in the Federal Register on

December 19, 1994 (59 FR 65372),

August 10, 1995 (60 FR 40847) and June

17, 1996 (61 FR 30623). Thus, for many

years the OIG has been publishing

substantial guidance indicating what

practices are lawful and what practices

the OIG considers unlawful under the

anti-kickback statute.

C. Advisory Opinions: Section 205 of

Public Law 104–191

The Health Insurance Portability and

Accountability Act of 1996, Public Law

104–191, effective August 21, 1996, now

requires the Department 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. Among the

provisions set forth in section 205 of

Public Law 104–191 is the requirement

that the Department, in consultation

with the Department of Justice (DoJ),

issue written advisory opinions to

particular parties with regard to: (1)

What constitutes prohibited

remuneration under the anti-kickback

statute; (2) whether an arrangement or

proposed arrangement satisfies the

criteria in section 1128B(b)(3) of the

Social Security Act, or established by

regulation, for activities which do not

result in prohibited remuneration; (3)

what constitutes an inducement to
Federal Register / Vol. 62, No. 33 / Wednesday, February 19, 1997 / Rules and Regulations 7351

1 Public Law 104–191 cited this provision as

section 1128B(b) of the Act. We believe the correct

reference is section 1128A(b).

reduce or limit services under section

1128A(b) of the Act to Medicare or

Medicaid program beneficiaries 1; and

(4) whether an activity or proposed

activity constitutes grounds for the

imposition of civil or criminal sanctions

under sections 1128, 1128A or 1128B of

the Act. Thus, advisory opinions will be

issued with regard to the provisions

authorizing the Department to exclude

individuals and entities from

participation in Medicare and the State

health care programs. Section 1128 of

the Act authorizes exclusion in a wide

variety of circumstances, for example,

conviction of health care related

offenses, State licensure action, and

submission of claims in excess of usual

charges or for services which fail to

meet professionally recognized

standards of health care. Similarly, the

civil money penalty provisions of

section 1128A of the Act authorize

penalties and exclusion for a variety of

acts, for example, presentation of a

Medicare or Medicaid claim that is false

or fraudulent, and hospital payments to

physicians to induce the physician to

reduce or limit care to any Medicare or

Medicaid beneficiary under the

physician’s direct care. The Department

will also provide advisory opinions

regarding the criminal provisions of

section 1128B of the Act which includes

the anti-kickback statute.

(On December 31, 1996, the OIG, in

accordance with section 205 of HIPAA,

published a notice in the Federal

Register (61 FR 69060) that solicited

proposals and recommendations for

developing new and modifying existing

safe harbor provisions under the

Medicare and State health care

programs’ anti-kickback statute, as well

as for developing new OIG Special

Fraud Alerts. We specifically indicated

in that notice our intention of

publishing separate rulemaking

addressing the procedures and process

for accepting and issuing advisory

opinions and soliciting public

comments and recommendations in this

area.)

In accordance with the statute,

requests for advisory opinions must be

accepted for agency review on or after

February 21, 1997. While the President’s

fiscal year 1998 budget submission

proposes a repeal of section 205, the

OIG and the Department are proceeding

to implement these statutory obligations

in accordance with existing law.

D. Waiver of Proposed Rulemaking

In developing and publishing these

regulations as an interim final rule, the

Secretary has determined that for good

cause it is both impracticable and

contrary to public interest to first issue

these regulations in proposed

rulemaking form. We believe that the

statutory requirement that final

regulations addressing the advisory

opinion process be in effect no later

than February 17, 1997, makes it

impracticable to develop such

procedures with the necessary intergovernmental collaboration and initial

public comment usually required in

such rulemaking by the statutory

deadline.

In addition, we believe that it is

imperative that we have in place

specific procedures by February 21,

1997, to address the receipt and

processing of advisory opinion requests.

It would be against the public interest

to proceed to receive and process

advisory opinions without setting forth

procedural guidance. However, we

believe that the 60-day period for public

comments being set forth in this interim

final rule will serve to protect the

public’s interest in this rulemaking

process by allowing for an opportunity

for additional input and

recommendations, without unduly

delaying the intent of these regulations.

We will respond to all appropriate and

relevant public comments received

during the 60-day comment period, and

make any necessary revisions to these

regulations through a revised final rule

to be issued, if possible, within 9

months of the close of the comment

period. Accordingly, we believe this

interim final rule approach will achieve

the dual purpose of issuing a

rulemaking consistent with statutory

time frames while soliciting and

benefiting from the public comment

process.

II. Provisions of the Interim Final Rule

Anti-kickback Statute Advisory

Opinions: ‘‘Case specific’’ Safe Harbors

These interim final regulations

establish a new 42 CFR part 1008 that

is designed to establish procedures for

advisory opinions that will provide the

public with meaningful advice

regarding the anti-kickback and other

OIG sanction statutes regarding specific

factual situations. With respect to the

anti-kickback statute, these procedures

contemplate particularized or ‘‘case

specific’’ safe harbors. In establishing

the regulatory safe harbors in§ 1001.952,

the OIG first considered the full scope

of factual circumstances potentially

subject to the anti-kickback statute, that

is, generally all types of arrangements

that could potentially involve an

intentional payment of remuneration to

induce the referral of Medicare

business. Next, we proceeded to ‘‘limit

the reach of the statute somewhat by

permitting certain non-abusive

arrangements, while encouraging

beneficial or innocuous arrangements.’’

(56 FR 35952, July 29, 1991). Thus we

sought to specify particular safe harbors

that, despite the potentially unlawful

intent, would protect non-abusive

relationships. To accomplish this

objective, each safe harbor contains

limitations and controls that provide

adequate assurance that the programs

will not be abused. The actual intent of

the parties is entirely irrelevant to this

analysis. The OIG has designed 13 final

safe harbors that describe practices that

are sheltered from liability, even though

unlawful intent may be present, and is

continuing to finalize 8 additional safe

harbor provisions.

The OIG views the advisory opinion

process with a means of analysis similar

to the safe harbor provisions, with one

major exception. Where the safe harbors

describe generalized, hypothetical

arrangements which are protected, we

view an advisory opinion as a means of

relating the anti-kickback statute to the

particular facts of a specific

arrangement. There are likely to be

factors that make some specific

arrangements appropriate for a favorable

advisory opinion, even in subject matter

areas where a generalized safe harbor

may be impractical. Thus, we believe

that particularized or ‘‘case specific’’

safe harbor treatment is appropriate

where the specific arrangement contains

limitations, requirements or controls

that give adequate assurance that

Federal health care programs can not be

abused.

These regulations are designed to

avoid the potential pitfalls of advisory

opinions on intent-based statutes, such

as the anti-kickback statute. First, it is

not practical for the agency to make an

independent determination of the

subjective intent of the parties based

only upon written materials submitted

by the requestor. While requestors are

required to submit a complete written

description of the transaction, along

with copies of the documents that

establish the arrangements in question,

these materials do not afford a

satisfactory basis upon which to make a

reliable determination of subjective

intent. In anti-kickback cases, the intent

issue is whether one purpose of the

remuneration in question is intended to

induce the referral of Federal program

business. In anti-kickback cases under

investigation, the determination of this
7352 Federal Register / Vol. 62, No. 33 / Wednesday, February 19, 1997 / Rules and Regulations

issue requires substantial independent

investigation of all facts and

circumstances surrounding the

transaction, usually including extensive

interviews. It is most unlikely that

written materials prepared by the

requestor could encompass all the

information necessary to enable the OIG

to make a reliable determination of the

subjective intent of the parties.

The second potential pitfall is that

advisory opinions are capable of being

misused by persons not a party to the

transaction in question in order to

inappropriately escape liability. While

the safe harbors are intended to create

exemptions that apply generally,

advisory opinions are intended to

address the facts of a particular

arrangement. A third party may

implement an arrangement that appears

similar to the arrangement described in

the advisory opinion, but the third party

may introduce additional factors that

may make a difference in the outcome

of an advisory opinion. Thus, advisory

opinions are binding upon and may

legally be relied upon only by the

requestor(s).

We believe that these regulations

provide for meaningful guidance to the

public on the statutes for which

advisory opinions are authorized, while

avoiding the potential pitfalls described

above.

As set forth, these interim final

regulations have been developed

primarily to address: (1) The procedures

to be followed by a party applying for

advisory opinions; (2) the procedures to

be followed by the OIG in responding to

these requests; (3) the time frames under

which the OIG will receive and respond

to requests for advisory opinions; (4) the

type and amount of fees to be charged

to the party requesting an advisory

opinion; and (5) the manner in which

the general public will be informed of

the issuance of any advisory opinions

by the OIG.

These regulations do not address the

substance or the content of advisory

opinions by the OIG.

Responsibilities of Outside Parties

Seeking Advisory Opinions

Any individual or entity may submit

a request for an advisory opinion.

However, since we anticipate that most

requests will apply to health care

business arrangements, for purposes of

this discussion, we will generally use

the term ‘‘arrangement’’ to refer to the

factual circumstances under which an

advisory opinion is requested, even

though we realize that some requests

will involve facts that are not related to

a business arrangement.

As indicated above, the advisory

opinion process is designed to provide

authoritative guidance to participants in

particular arrangements. Therefore, the

regulations indicate that the

arrangement in question must either be

in existence at the time of the request

for an advisory opinion, or with respect

to prospective arrangements, there must

be a good faith intention to enter into

the described arrangement in the near

future. (With respect to prospective

conduct, we are stating that the

requestor can declare the intention to

enter into the arrangement contingent

on the receipt of a favorable advisory

opinion.)

We do not believe that it is

appropriate to provide advisory

opinions to persons not involved in the

arrangement in question. For example,

we believe that a description of a

competitor’s arrangement is not the

proper subject of an OIG advisory

opinion since the participants to the

particular transaction would not be

involved in the request. A party to an

actual arrangement—either existing or

about to be entered into—is in a

position to provide full and complete

information regarding the facts in

question. By contrast, third parties are

not in a position to provide a reliable

statement as to the facts of a particular

arrangement in which the third party is

not a participant. In addition, it is

unclear who would be bound by an

advisory opinion on an arrangement not

involving the requestor.

Similarly, we do not believe it is

appropriate to provide advisory

opinions on hypothetical or generalized

arrangements for several reasons. First,

the anti-kickback statute and the other

OIG sanction statutes impose liability

with respect to acts by specific people

in particular factual circumstances, i.e.,

the context in which prosecutive

decisions are made. Anti-kickback cases

are almost never alike in all material

respects. In addition, especially with

intent-based statutes like the antikickback statute, it is often not possible

to determine that a particular general

practice is invariably good or bad. An

arrangement may be legal under the

anti-kickback statute with respect to one

party, but not with respect to a second

party. Such differing results can be a

function of the different intentions of

the two parties, or a function of the

introduction by a party of additional

factors that would make a material

difference in the resulting opinion. We

believe it would not be possible for an

advisory opinion reliably to identify all

the possible hypothetical factors that

might lead to different results.

Moreover, the OIG already has in

place a process for offering guidance on

the application of the OIG’s legal

authorities to hypothetical or

generalized factual circumstances—the

safe harbor provisions and Special

Fraud Alerts. As indicated above, the

OIG has promulgated 13 final safe

harbor provisions in § 1001.952, and has

proposed several others specifying

generalized payment practices that will

not be subject to sanction under the

Medicare and Medicaid anti-kickback

statute. Members of the public may also

now under section 1128D(a) of the Act

submit proposals for additional safe

harbor regulations to the OIG. Further,

in accordance with section 1128D(c) of

the Act, if a member of the public is

aware of a practice that may be suspect

or of particular concern under Medicare

or a State health care program, they may

request the OIG to issue a Special Fraud

Alert regarding the practice.

Requestors who are not individuals

are required to disclose certain

ownership and control information, so

that the appropriate checks can be made

to ensure that the matter which is the

subject of the advisory opinion request

is not under current investigation.

Initiating the Process for an Advisory

Opinion

To initiate the advisory opinion

process, we are indicating in part 1008

that the requestor must submit a written

request for an advisory opinion. The

request must clearly and thoroughly

present a complete description of the

facts for which an advisory opinion is

being requested. To the extent that the

subject matter of the request is the

requestor’s potential liability under one

sanction authority, we believe the

request should provide a complete

description of the facts addressing the

elements of that authority. Under these

interim final regulations, if the request

asks the OIG to advise on whether an

arrangement is subject to sanction under

more than one legal authority, we

believe the submission should include a

complete description of the facts

regarding the different sanction

authorities in those statutes. To the

extent that the necessary information is

provided in a clear and orderly manner,

the OIG will be better able to process the

request.

The regulations are requiring any

submission to include copies of all

relevant documents, such as contracts,

leases, employment agreements and

court documents, as well as descriptions

of any other understandings that may

affect the documents. In addition, the

submission should include a narrative

description of the arrangement. As
Federal Register / Vol. 62, No. 33 / Wednesday, February 19, 1997 / Rules and Regulations 7353

indicated in § 1008.36, in making the

request, the identities (including names

and addresses) of the requestor and all

other actual and potential parties, to the

extent known to the requestor to the

arrangement that is the subject of the

request to the advisory opinion must be

included. In addition, the requestor

must identify a designated contact

person who will be available to

communicate with the OIG.

We are requesting comments on the

certification process being adopted.

Under these regulations at this point we

are requiring two certifications to be

made in a request for an advisory

opinion. The certifications must be

signed by the individual (if an

individual requestor), the Chief

Executive Officer, or comparable officer

of the company (if a corporate

requestor), or the managing partner (if a

partnership is the requestor). The

responsible individual must certify that

all of the information provided is true

and correct, and constitutes a complete

description of the facts regarding which

an advisory opinion is sought, to the

best of the knowledge of the requestor.

Where the request relates to prospective

conduct, the regulations state that the

request must also include a certification

that the requestor intends in good faith

to enter into the arrangement described

in the request. This certification may be

made contingent upon receipt of a

favorable advisory opinion.

Under these interim final regulations,

while all submissions should include

the above information, because of the

wide variety of activities upon which

the OIG must issue advisory opinions,

we cannot detail at this point all of the

information a requestor must provide.

We are requesting public comment and

input on the type of information to be

provided by the requesting party and

will address this point further in any

revised final rulemaking. In the interim,

prior to submitting a request for an

advisory opinion, the requestor is

advised to contact the OIG to inquire

about the information needed by the

OIG to process a request of the type the

requestor intends to submit. Inquiries

should be made in writing and sent to

the Office of Inspector General, Office of

Counsel to the Inspector General,

Industry Guidance Branch, Room 5246

Cohen Building, 330 Independence

Avenue, S.W., Washington, D.C. 20201.

(Any changes to this address regarding

inquiries will be posted on the OIG

home page at http://www.sba.gov/ignet/

internal/hhs/hhs.html.) The OIG may,

depending on the subject matter of the

inquiry, provide the requestor with

preliminary questions designated to

elicit the factual information necessary

to facilitate an OIG response to the

request. These questions should be (but

are not required to be) answered in the

request for an advisory opinion.

If the information needed by the OIG

is in the preliminary submission, we

will be better able to render a prompt,

concise and appropriate advisory

opinion. We welcome comments on this

approach.

Fees Charged to Requesting Parties

Section 1128D(b)(5)(B)(ii) of the Act

requires that requestors be charged a fee

equal to the costs incurred by the

Department in responding to the

request. The fee must be paid into the

general fund of the U.S. Treasury.

Section 1008.31 of these regulations

indicates that the actual costs of

responding to requests for advisory

opinions will factor in the salary,

benefits and overhead costs of attorneys

and others who will work on analyzing

requests and writing advisory opinions

from requesting parties. In light of the

breadth of subject matter and possible

range of complexities for advisory

opinion requests, we do not believe it is

possible to calculate or accurately

estimate the actual cost of providing an

advisory opinion in advance. Indeed,

we believe that the statute requires us to

calculate the actual costs incurred

during the processing of a specific

request and charge the requestor for that

amount. As set forth in these

regulations, at the conclusion of the

advisory opinion process, when either

the opinion has been issued or the

request has been withdrawn, the

requestor is responsible for paying the

U.S. Treasury an amount equal to the

costs incurred by the Government in

responding to the request.

Although we cannot reliably project

the processing costs in advance, we can

make broad estimates that may be of use

to prospective requestors. We estimate

that the actual cost of processing

requests, including salaries, benefits and

overhead, will be near $100 per hour.

We must include the time of staff

attorneys, supervisors and support staff,

as well as others who are consulted on

various issues. The processing time will

vary according to the complexity of the

request and the quality of the

submission. Simple requests, for

example, regarding whether a certain

court action is a conviction for the

purposes of exclusion in accordance

with section 1128 of the Act may take

approximately 3 hours to analyze and

produce a written opinion. On the other

hand, requests involving the application

of the anti-kickback statute to large,

multiple party, intricate business deals

may take in excess of 40 hours or more

to fully analyze and produce a written

advisory opinion.

We believe that it is reasonable to

expect that requests for an advisory

opinion will cost at least $250 in initial

processing. Every request for an

advisory opinion will take time to read

and analyze for the OIG to ensure that

it has an accurate understanding of all

material facts submitted. Following that

initial analysis, the OIG is required to

consult with the DoJ and write the

actual advisory opinion. By its very

nature, most of this work will need to

be done by the OIG staff attorneys.

Accordingly, the regulations are

providing for a non-refundable payment

of $250 that is to accompany the request

for an advisory opinion. Once we have

gained experience in the time and staff

resources involved in this process, a

clearer estimate may need to be made

and a re-calculation set forth.

Because we do not believe that we can

accurately estimate our costs in advance

for a particular request, we are

attempting to accommodate requestors

who may want to limit the costs of

receiving an advisory opinion. The

regulations provide that a requestor may

designate a ‘‘triggering dollar amount’’

in their request for an advisory opinion.

If the OIG calculates that the cost of

processing the request has reached, or is

likely to exceed, that triggering amount,

the OIG will stop processing the request

and promptly notify the requestor. The

requestor may then decide to either

authorize continued processing or

withdraw the request for an advisory

opinion. While the OIG intends to be

able to more accurately reflect such

costs in advance as experience is

gained, this triggering mechanism

approach should ensure that requestors

do not pay costs far in excess of what

they expect to incur by their request.

Section 1008.39 of the regulations

specifically indicates that while a

requestor may withdraw a request for an

advisory opinion at any time, he or she

will be responsible for any costs

incurred in processing the request prior

to its withdrawal.

When the advisory opinion has been

completed as discussed below, or the

request has been withdrawn, the OIG

will calculate the total costs incurred in

processing the request after taking into

account any previous payments, such as

the initial $250 fee, associated with the

request, and the OIG will then notify the

requestor of the amount owed. Once the

requestor has paid the full amount owed

for the cost of processing the request as

required by statute, the OIG will release

the advisory opinion to the requestor.

While the OIG believes the above

approach for payment and release will
7354 Federal Register / Vol. 62, No. 33 / Wednesday, February 19, 1997 / Rules and Regulations

be sufficient for the vast majority of

requests for advisory opinions, an

additional procedure will be necessary

in those cases where the request

requires expert advice on non-legal

matters. The OIG is particularly

concerned about requests for advisory

opinions requiring review by medical

experts. For example, section

1128(b)(6)(B) of the Act authorizes the

OIG to exclude any individual or entity

who has furnished services to patients

‘‘substantially in excess of the needs of

such patients or of a quality which fails

to meet professionally recognized

standards of health care.’’ In order to

determine whether a given factual

scenario would form the basis for a

sanction under this authority, as stated

in § 1008.33 of these regulations, the

OIG may make a determination that

extensive medical as well as legal

analysis is required, and that the

medical analysis should be referred to a

Peer Review Organization or other

entity capable of providing and issuing

medical reviews.

Because of the time and expense of

such expert reviews, we believe that a

request that requires such outside

consultation should be treated

differently from a standard request

involving the application of the

governing law to a given set of facts.

When the OIG determines that an expert

non-legal opinion is required, we will

obtain an estimate for the costs of such

an opinion and provide the requestor

with that estimate. The requestor may

then decide whether to pay the

estimated cost of the expert review or

withdraw the request. If the requestor

pays the estimated cost, the OIG will

promptly refer the matter to the expert

for such review. Once the OIG receives

the medical or other review from the

outside expert, the advisory opinion

process will continue with the OIG

applying the expert evaluation to the

legal question(s) at issue.

Responsibilities of the OIG in Reviewing

the Advisory Opinion Requests

Subpart E of part 1008 discusses the

obligations and responsibilities of the

OIG in answering requests for advisory

opinions. As set forth in these

regulations, once the OIG receives a

request for an advisory opinion, we will

promptly examine it to determine if it

appears to contain sufficient

information to form the basis for an

informed advisory opinion. Generally

speaking, the request must contain

responses to the preliminary questions

posed by the OIG, as discussed above.

If the request does not appear sufficient,

we will promptly notify the requestor

what additional information is required.

Conversely, if the request appears to be

sufficient, we will accept the request. In

all cases, we will either request

additional information or accept the

request within 10 working days after

receiving the request. If we have

requested additional information and

the requestor resubmits the advisory

opinion request, we will assess within

10 working days the resubmission to

determine whether it can be accepted or

whether we still need further

information. At the point when the OIG

accepts the request, we will notify the

requestor by U.S. mail of the date of

acceptance.

We believe that this approach allows

the OIG a reasonable amount of time to

identify requests that do not contain

information sufficient for the OIG to

process the request. While we are

limiting the time period of this initial

assessment to ensure that facially

complete requests are promptly

processed, we are soliciting public

comment on the appropriateness of this

method of screening requests for

advisory opinions prior to their

acceptance.

Notwithstanding the acceptance of a

request, the OIG reserves the right to

later determine that it needs additional

information. If we decide such

additional information is necessary, we

will notify the requestor in the same

manner as we did prior to acceptance.

The time period between when we

notify the requestor about the additional

information we need and when we

receive the requested information will

not be counted in considering the time

for issuance of an opinion.

Because of the fact-intensive inquiry

that will be necessary to render most

advisory opinions, the OIG anticipates

that there may be a need to request

additional information from many

requestors. In responding, the requestor

should provide the OIG with the

necessary information and accompany

that submission with a certification

from the same individual (or one in the

same position) who certified the original

request for an advisory opinion.

As required by section 1128D(b)(5)(B)

of the Act and set forth in § 1008.43, the

OIG will issue an advisory opinion

within 60 days after the request for the

opinion is accepted. Once the OIG

receives a request for an opinion that

appears to meet the submission criteria,

the request for an opinion will be

promptly accepted and the 60-day time

period for issuance of an opinion will

commence. The OIG will send the

advisory opinion to the requestor by

regular U.S. mail at the conclusion of

the 60-day time period and once all

required fees have been paid.

We believe that under certain

circumstances the running of the 60-day

time limit for issuing an opinion should

be tolled. The tolling periods will only

reflect time when the OIG cannot work

on analyzing the request. If the OIG

notifies the requestor that the costs have

reached, or are likely to exceed, the

triggering amount designated by that

requestor, the OIG will stop processing

the request until the requestor instructs

the OIG to continue. Similarly, if the

OIG notifies a requestor of the need for,

and estimated cost of, an outside expert

opinion on a non-legal issue, the

regulations state that the OIG will stop

processing the request until the

requestor pays the estimated cost and

the outside expert provides its opinion.

Likewise, in those instances when the

OIG requests additional information

from the requestor that the OIG believes

is necessary to issue the advisory

opinion, the OIG will stop processing

the opinion until the additional

information is provided. The time that

elapses during these periods when the

OIG is not processing the request will

not be counted as part of the 60-day

period.

The time period for issuing an

advisory opinion does not include the

time after the OIG notifies the requestor

that the advisory opinion is completed

and the requestor must pay the full

balance due for the cost of the opinion.

While the OIG intends to issue

advisory opinions within 60 days of the

receipt of the request, we do not believe

that the 60-day time period should

include delays in the processing of the

request that are not within the control

of the OIG. With the exception of the

delay while waiting for a needed

outside expert opinion, all of the

possible tolling events are under the

exclusive control of the requestor, and

as such, since for what we believe will

be the vast majority of advisory opinion

requests, the 60-day period will only be

tolled for those periods during which

the requestor has not paid a required fee

or has not provided information

necessary to the processing of the

request.

As required by section 1128D(b)(1) of

the Act, the OIG will consult with DoJ

when responding to requests for

advisory opinions, and will issue an

advisory opinion to the requestor after

considering the complete description of

all facts provided to it by the requestor.

The opinion will restate the material

facts known to the OIG and discuss the

OIG’s analysis and conclusion regarding

the legal question(s) to be applied to the

facts presented.
Federal Register / Vol. 62, No. 33 / Wednesday, February 19, 1997 / Rules and Regulations 7355

Dissemination of Advisory Opinions

Section 1128D(b)(5)(A)(v) requires

these regulations to describe the manner

in which advisory opinions will be

made available to the public. As set

forth in subpart E of these regulations,

once the OIG issues an advisory opinion

to a requestor, the OIG will promptly

make a copy of that opinion available

for public inspection at the OIG

headquarters and the DHHS/OIG web

site. We also anticipate that advisory

opinions will likely be made widely

available to interested members of the

public through commercial publishers

and trade groups. Public comments and

additional suggestions regarding the

dissemination of advisory opinions to

the public will be welcomed.

Documents submitted to the OIG

related to requested advisory opinions,

and internal government documents

related to such opinions, will be

available to the extent authorized by the

Freedom of Information Act (FOIA) (5

U.S.C. 552). To the extent that a

requestor provides information it

believes is not subject to disclosure

under FOIA, such as items that the

requestor believes are trade secrets or

privileged and confidential commercial

or financial information, the requestor

should identify such information in the

manner described in 45 CFR 5.65 (c)

and (d). The requestor’s assertions about

the nature of information, however, are

not controlling.

In addition, although a document may

be exempt from disclosure under FOIA,

facts reflected on that document may

become part of the advisory opinion that

will be provided to the public. The

material facts of the arrangement in

question will be described in the body

of each advisory opinion, all of which

will be fully available to the public.

Rescission of an Advisory Opinion

Section 1008.45 of the regulations

addresses the rescission of an advisory

opinion by the OIG. The regulations

reserve the right of the OIG to rescind

an advisory opinion after its issuance in

limited circumstances, such as when the

OIG learns after the issuance of the

opinion that the arrangement in

question may lead to fraud and abuse.

In such an instance, the OIG will notify

the requestor of the rescission and make

such notice available to the same extent

as an advisory opinion. Unless the OIG

establishes that the requestor failed to

provide material information in its

submissions to the OIG, the requestor

would not be subject to OIG sanction for

actions it took prior to the notice of

rescission if the requestor acted in good

faith reliance on the advisory opinion.

We are specifically soliciting comments

on whether this approach reasonably

balances the Government’s need to

ensure that advisory opinions are legally

correct and the requestor’s interest in

finality.

Scope and Effect of Advisory Opinions

Subpart F of part 1008 of these

regulations addresses the scope and

effect of advisory opinions. An advisory

opinion issued under this process is

legally binding on the Department

(including the OIG) and the requestor,

but only with respect to the specific

conduct of the particular requestor. In

other words, in accordance with section

1128D(b)(4)(A) of the Act with respect

to the issuance of advisory opinions, the

Department is not legally bound with

respect to the conduct of third parties,

even if the conduct of that party appears

similar to the requestor. We believe that

no third parties are bound nor may they

rely on an advisory opinion since each

advisory opinion will apply legal

standards to a set of facts involving

certain known persons who provide

specific statements about key factual

issues. A third party may implement a

look-alike arrangement with additional

characteristics that would lead to an

unfavorable opinion. Therefore, by their

very nature, advisory opinions, unlike

the safe harbor regulations, cannot be

applied generally.

We believe the receipt of an advisory

opinion regarding a certain arrangement

does not totally prevent the Government

from commencing an action against a

party to the arrangement where, for

example, a requestor failed to disclose a

material fact. In any such action under

sections 1128, 1128A or 1128B of the

Act, an individual or entity who has

requested and received an advisory

opinion from the OIG regarding the

arrangement in question may seek to

introduce the advisory opinion into

evidence in the proceeding. We believe

that the court must then determine

whether the requestor of the advisory

opinion was justified in relying on the

opinion. This determination must be

made by examining all relevant

circumstances, including whether the

requestor fully and accurately described

the arrangement in its submissions to

the OIG.

III. Regulatory Impact Analysis

Executive Order 12866

The Office of Management and Budget

(OMB) has reviewed this interim final

rule in accordance with the provisions

of Executive Order 12866. 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).

As indicated in section II of this

preamble, this rule deals primarily with

the procedural issues involved in the

receipt, review and response to requests

for advisory opinions by the OIG. It sets

up the procedures as required by Public

Law 104–191, for obtaining an advisory

opinion on whether or not certain

activities violate designated fraud and

abuse authorities. This rule does not

address the substance of the antikickback or other sanction statutes. It

does not address the substance or

content of advisory opinions which may

be issued in the future. To the extent

that advisory opinions affect the

behavior of health care providers, that

effect is the product of the substantive

content of the sanction statutes

themselves, and the substantive content

of the advisory opinions which will be

issued on a case-by-case basis in the

future. The effect of advisory opinions

on health care providers is not a

function of the process for requesting an

advisory opinion.

In addition, the extent to which

advisory opinions will result in

alteration of future business practices, if

any, is impossible to analyze without

experience. It would be completely

speculative to try to divine to what

degree business deals may or may not

occur as a result of the substance of

advisory opinions issued in the future.

Moreover, we have no way of

knowing in advance what the volume of

requests for advisory opinions will be.

However, we estimate that we will

receive approximately 500 requests per

year that will generally require between

3 and 40 hours each to process.

Accordingly, it would likely cost in the

range of $150,000 to $2,000,000 per year

to issue advisory opinions.

Regulatory Flexibility Act

Under the Regulatory Flexibility Act

(5 U.S.C. 601–612), if a rule has a

significant economic effect on a

substantial number of small businesses

the Secretary must specifically consider

the effects of a rule on small business

entities and analyze regulatory options

that could lessen the impact of the rule.

As stated above, this rule does not

address the substance of the fraud and

abuse statutes or the substance of

advisory opinions which may be issued

in the future. It describes the process by

which an individual or entity may

receive an opinion as to the application

of these statutes to particular business
7356 Federal Register / Vol. 62, No. 33 / Wednesday, February 19, 1997 / Rules and Regulations

practices. The aggregate economic

impact of this rulemaking on small

business entities should, therefore, be

minimal.

There will, however, be costs

involved in filing requests for opinions

by OIG. Those costs will vary depending

on the complexity of the request.

Compared to the costs of seeking private

legal advice, it would appear that fees

charged for the OIG’s review would not

be substantial. Furthermore, the

requirement that applicants pay costbased fees for advisory opinions is not

a product of this rulemaking: It is

prescribed by statute that such fees be

paid by those requesting advisory

opinions. This rule merely lays out the

procedures for such costs to be paid.

Thus, we have concluded, and the

Secretary certifies, that this final rule

will not have a significant economic

impact on a substantial number of small

business entities, and that a regulatory

flexibility analysis is not required for

this rulemaking.

IV. Paperwork Reduction Act

In order to provide appropriate

advisory opinions, the OIG will need

certain information from the parties

who request advisory opinions. Sections

1008.18, 1008.36(b) and 1008.37

through 1008.40 of this interim final

rule contain information collection

requirements that require approval by

OMB. We are required to solicit public

comments under section 3506(c)(2)(A)

of the Paperwork Reduction Act of 1995.

Specifically, comments are invited 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 respondents, including

through the use of automated collection

techniques or other forms of information

technology.

We are seeking emergency OMB

approval for the collection of

information contained in this rule. In a

separate Federal Register notice,

containing a 60-day public comment

period, we will solicit public comment

on these requirements, thereby initiating

the normal Paperwork Reduction Act

clearance.

Title: OIG Advisory Opinion

Procedure.

Summary of the collection of

information: Section 205 of Public Law

104–191 requires the Department to

provide advisory opinions to the public

regarding several categories of subject

matter. The Department must opine on

requestor’s potential liability under

sections 1128, 1128A, and 1128B of the

Act. These regulations provide the

procedures under which members of the

public may request advisory opinions

from the OIG. Because all requests for

advisory opinions are purely voluntary,

respondents will only be required to

provide information regarding facts

about which they have decided to

request an opinion from the OIG.

In order to ensure a useful advisory

opinion process, the OIG must receive

information sufficient to determine

whether the arrangement in question is

subject to sanction. The information

provided by the requestor will be

applied by the OIG to the legal question

posed in the request for an advisory

opinion. In general, we are requiring a

complete description of all facts

relevant to the inquiry, including all

related documents.

The general requirements in this

rulemaking may be supplemented by

voluntary preliminary questions we

have developed that correspond with

each sanction authority in sections

1128, 1128A, and 1128B of the Act as

appropriate. These more specific

information collection requirements are

being made available for public review

and comment by a separate Federal

Register notice. The preliminary

questions will be designed to elicit the

specific information that will enable the

OIG to provide the most accurate and

timely opinion possible. For example, if

a request is made for an advisory

opinion on whether a given arrangement

will violate the anti-kickback statute,

one question may relate specifically to

how much remuneration is paid to

various parties to the arrangement.

Although requestors will be under no

obligation to answer the preliminary

questions, we believe that the questions

will provide requestors with valuable

guidance about what information we

will need to answer their inquiry. A

request for an advisory opinion that

includes complete answers to the

preliminary questions corresponding to

the issue(s) raised by the requestor

should contain most, if not all, of the

information that we will require to issue

an advisory opinion. Even though we

believe that the questions will aid

requestors, the answering of these

questions is purely voluntary in nature

and we will process advisory opinion

requests regardless of whether the

preliminary questions are answered.

The following discussion relates the

aggregate effect of the collections of

information included in the text of this

interim final rule and in the preliminary

questions.

Respondents: The ‘‘respondents’’ for

the collection of information described

in these regulations will be self-selected

individuals and entities that choose to

submit requests for advisory opinions to

the OIG. We anticipate that the

respondents will include health care

providers of many types, from sole

practitioner physicians to large

diversified publicly-traded corporations.

Estimated number of respondents:

500. Most individuals and entities that

provide medical services that may be

paid for by Medicare, Medicaid or

Federal health care programs could

potentially have questions regarding one

of the subject matters about which the

OIG will issue advisory opinions. In

reality, we believe that the number of

requestors will be a small fraction of

such providers.

Over the past several years, the

Inspector General Division of the Office

of the General Counsel has answered

telephone inquiries from individuals

and entities seeking informal guidance

with respect to the Medicare and State

health care programs’ anti-kickback

statute and other sanction authorities.

Many of the inquiries related to

authorities outside the scope of the

advisory opinion process, that is, the

self-referral provisions of section 1877

of the Act. Furthermore, we believe that

most of the inquiries have been of a

nature that the caller would be unlikely

to request a written advisory opinion on

the subject matter. Many inquiries

related to relatively simple matters that

could be researched by private counsel

at relatively minor expense.

Nevertheless, the rate of these telephone

inquiries may form a starting point for

estimating the number of advisory

opinion requests. We estimate that we

received an average of 6 telephone

inquiries per day over the past several

years. Of these, we believe that an

average of two per day could potentially

have been the subject of an advisory

opinion. Using that history as a rough

guide, we estimate an annual number of

500 requests. Obviously, the actual

number of requests could be larger

since, for the first time, formal written

opinions are available. Conversely, the

numbers could be smaller for a

combination of many unquantifiable

reasons, such as the desire not to subject

an arrangement to official scrutiny.

Estimated number of responses per

respondent: 1.

Estimated total annual burden on

respondents: We believe that the burden

of preparing requests for advisory

opinions will vary widely because of

differences in size and complexity of the
Federal Register / Vol. 62, No. 33 / Wednesday, February 19, 1997 / Rules and Regulations 7357

business transaction in question. We

estimate that the average burden for

each submitted request for an advisory

opinion will be in the range of 2 to 40

hours. We further believe that the

burden for most requests will be closer

to the lower end of the range, with an

average burden of 10 hours per

respondent. Total burden for this

proposed information collection is

estimated to be 5000 hours.

We are requiring requests for advisory

opinions to involve existing conduct, or

conduct in which the requestor intends

to engage. We anticipate that most

requests will involve business

arrangements into which the requesting

party intends to enter. Because the facts

will relate to business plans, the

requesting party will have collected and

analyzed all or almost all of the

information we will need to collect to

review the request. Therefore, in order

to request an advisory opinion, the

requestor will most likely simply need

to compile already collected

information for our examination. In

some cases, however, the requestor may

need to expend a more significant

amount of time in preparing a

submission related to a complex

arrangement involving a large number of

parties.

In addition to the hour burden

discussed above, some respondents may

incur additional costs related to the

purchase of outside professional

services, such as attorneys or

consultants. We believe that the cost

burden related to such outside

assistance will vary from zero to 40

hours per submission. The outside

assistance cost burden estimate is based

on an estimate of 10 hours per request

at $200 per hour. Thus, the cost burden

for these outside functions is estimated

at $1,000,000.

Comments on this information

collection should be sent to both:

Cynthia Agens Bauer, OS Reports

Clearance Officer, ASMB Budget

Office, Room 503–H, Humphrey

Building, 200 Independence Avenue,

S.W., Washington, D.C. 20201, FAX:

(202) 690–6352

Allison Herron Eydt, OIG Desk Officer,

Office of Management and Budget,

Room 10235, New Executive Office

Building, 725 17th Street, N.W.,

Washington, D.C. 20053, FAX: (202)

395–6974.

Comments on these paperwork

reduction requirements may be

submitted to the above-cited individuals

within two days following the Federal

Register publication of this interim final

rule.

List of Subjects in 42 CFR Part 1008

Administrative practice and

procedures, Fraud, Grant programs—

health, Health facilities, Health

professions, Medicaid, Medicare,

Penalties.

Accordingly, 42 CFR chapter V,

subchapter B is amended by adding a

new part 1008 as set forth below:

TITLE 42—PUBLIC HEALTH

CHAPTER V—OFFICE OF INSPECTOR

GENERAL—HEALTH CARE, DEPARTMENT

OF HEALTH AND HUMAN SERVICES

PART 1008—ADVISORY OPINIONS BY

THE OIG

Subpart A—General Provisions

Sec.

1008.1 Basis and purpose.

1008.3 Effective period.

1008.5 Matters subject to advisory opinions.

Subpart B—Preliminary Obligations and

Responsibilities of the Requesting Party

1008.11 Who may submit a request.

1008.15 Facts subject to advisory opinions.

1008.18 Preliminary questions suggested for

the requesting party.

Subpart C—Advisory Opinion Fees

1008.31 OIG fees for the cost of advisory

opinions.

1008.33 Expert opinions from outside

sources.

Subpart D—Submission of a Formal

Request for an Advisory Opinion

1008.36 Submission of a request.

1008.37 Disclosure of ownership and

related information.

1008.38 Signed certifications by the

requestor.

1008.39 Additional information.

1008.40 Withdrawal.

Subpart E—Obligations and

Responsibilities of the OIG

1008.41 OIG acceptance of the request.

1008.43 Issuance of a formal advisory

opinion.

1008.45 Rescission.

1008.47 Disclosure.

Subpart F—Scope and Effect of OIG

Advisory Opinions

1008.51 Exclusivity of OIG advisory

opinions.

1008.53 Affected parties.

1008.55 Admissibility of evidence.

1008.59 Range of the advisory opinion.

Authority: 42 U.S.C. 1320a-7d(b).

Subpart A—General Provisions

§ 1008.1 Basis and purpose.

(a) This part contains the specific

procedures for the submission of

requests by an individual or entity for

advisory opinions to, and the issuance

of advisory opinions by, the OIG, in

consultation with the Department of

Justice (DoJ), in accordance with section

1128D(b) of the Social Security Act

(Act), 42 U.S.C. 1320a-7d(b). The OIG

will issue such advisory opinions based

on actual or proposed factual

circumstances submitted by the

requesting individual or entity.

(b) An individual or entity may

request an advisory opinion from the

OIG regarding on any of 5 specific

subject matters described in § 1008.5 of

this part.

(c) The requesting party must provide

a complete description of the facts as set

forth in subpart B of this part, and pay

the costs to the OIG of processing the

request for an advisory opinion as set

forth in subpart C of this part.

(d) Nothing in this part limits the

investigatory or prosecutorial authority

of the OIG, DoJ or any other agency of

the Government.

§ 1008.3 Effective period.

The provisions in this part are

applicable to requests for advisory

opinions submitted on or after February

21, 1997, and before August 21, 2000,

and to any requests submitted during

any other time period for which the OIG

is required by law to issue advisory

opinions.

§ 1008.5 Matters subject to advisory

opinions.

(a) An individual or entity may

request an advisory opinion from the

OIG regarding—

(1) What constitutes prohibited

remuneration within the meaning of

section 1128B(b) of the Act;

(2) Whether an arrangement, or

proposed arrangement, satisfies the

criteria set forth in section 1128B(b)(3)

of the Act for activities that do not result

in prohibited remuneration;

(3) Whether an arrangement, or

proposed arrangement, satisfies the

criteria set forth in § 1001.952 of this

chapter for activities that do not result

in prohibited remuneration;

(4) What constitutes an inducement to

reduce or limit services under section

1128A(b) of the Act to Medicare or

Medicaid program beneficiaries; and

(5) Whether any activity, or proposed

activity, constitutes grounds for the

imposition of a sanction under sections

1128, 1128A or 1128B of the Act.

(b) Exceptions. The OIG will not

address through the advisory opinion

process—

(1) What the fair market value will be,

or what the fair market value was paid

or received, for any goods, services or

property; and

(2) Whether an individual is a bona

fide employee within the requirements

of section 3121(d)(2) of the Internal

Revenue Code of 1986.
7358 Federal Register / Vol. 62, No. 33 / Wednesday, February 19, 1997 / Rules and Regulations

Subpart B—Preliminary Obligations

and Responsibilities of the Requesting

Party

§ 1008.11 Who may submit a request.

Any individual or entity may submit

a request to the OIG for an advisory

opinion regarding an existing

arrangement or one which the requestor

in good faith specifically plans to

undertake. The requestor must be a

party to the arrangement, or proposed

arrangement, that is the subject of the

request.

§ 1008.15 Facts subject to advisory

opinions.

(a) The OIG will consider requests

from a requesting party for advisory

opinions regarding the application of

specific facts to the subject matters set

forth in § 1008.5(a) of this part. The facts

must relate to an existing arrangement,

or one which the requestor in good faith

plans to undertake. The plans may be

contingent upon receiving a favorable

advisory opinion. The advisory opinion

request should contain a complete

description of the arrangement that the

requestor is undertaking, or plans to

undertake.

(b) Requests presenting a general

question of interpretation, posing a

hypothetical situation, or regarding the

activities of third parties do not qualify

as advisory opinion requests.

(c) An advisory opinion request will

not be accepted when—

(1) The request is not related to a

named individual or entity;

(2) The same, or substantially the

same, course of action is under

investigation, or is or has been the

subject of a proceeding involving the

Department of Health and Human

Services or another governmental

agency; or

(3) An informed opinion cannot be

made, or could be made only after

extensive investigation, clinical study,

testing or collateral inquiry.

§ 1008.18 Preliminary questions

suggested for the requesting party.

(a) The OIG may establish and

maintain a set of questions

corresponding to the categories of

opinion subject matter as set forth in

§ 1008.5(a) of this part as appropriate.

The questions will be designed to elicit

specific information relevant to the

advisory opinion being sought;

however, answering the questions is

voluntary.

(b) Questions the OIG suggests the

requestor to address may be obtained

from the OIG. Requests should be made

in writing, specify the subject matter

and be sent to the headquarter offices of

the OIG.

(c) When submitting a request for an

advisory opinion, a requestor may

answer the questions corresponding to

the subject matter for which the opinion

is requested. The extent to which any of

the questions is not fully answered may

effect the content of the advisory

opinion.

Subpart C—Advisory Opinion Fees

§ 1008.31 OIG fees for the cost of advisory

opinions.

(a) Responsibility for fees. The

requestor is responsible for paying a fee

equal to the costs incurred by the

Department in responding to the request

for an advisory opinion.

(b) Initial payment. A request for an

advisory opinion must be accompanied

by a check or money order payable to

the Treasury of the United States for

$250. This initial payment is nonrefundable.

(c) Calculation of costs. Prior to the

issuance of the advisory opinion, the

OIG will calculate the costs to be

incurred by the Department in

responding to the request. The

calculation will include the costs of

salaries and benefits payable to

attorneys and others who have worked

on the request in question, as well as

administrative and supervisory support

for such persons. The OIG has the

exclusive authority to determine the

cost of responding to a request for an

advisory opinion and such

determination is not reviewable or

waivable.

(d) Agreement to pay all costs. (1) By

submitting the request for an advisory

opinion, the requestor agrees, except as

indicated in paragraph (d)(3) of this

section, to pay all costs incurred by the

OIG in responding to the request for an

advisory opinion.

(2) In its request for an advisory

opinion, the requestor may designate a

triggering dollar amount. If the OIG

estimates that the costs of processing the

advisory opinion request have reached

or are likely to exceed the designated

triggering dollar amount, the OIG will

notify the requestor.

(3) If the OIG notifies the requestor

that the estimated cost of processing the

request has reached or is likely to

exceed the triggering dollar amount, the

OIG will stop processing the request

until such time as the requestor makes

a written request for the OIG to continue

processing the request. Any delay in the

processing of the request for an advisory

opinion attributable to these procedures

will toll the time for issuance of an

advisory opinion until the requestor

asks the OIG to continue working on the

request.

(4) If the requestor chooses not to pay

for completion of an advisory opinion,

or withdraws the request, the requestor

is still obligated to pay for all costs

incurred and identified by the OIG

attributable to processing the request for

an advisory opinion up to that point.

(5) If the costs incurred by the OIG in

responding to the request are greater

than the amount paid by the requestor,

the OIG will, prior to the issuance of the

advisory opinion, notify the requestor of

any additional amount due. The OIG

will not issue an advisory opinion until

the full amount owed by the requestor

has been paid. Once the requestor has

paid the OIG the total amount due for

the costs of processing the request, the

OIG will issue the advisory opinion.

The time period for issuing advisory

opinions will be tolled from the time the

OIG notifies the requestor of the amount

owed until the time full payment is

received.

(e) Fees for outside experts. (1) In

addition to the fees identified in this

section, the requestor also must pay any

required fees for expert opinions, if any,

from outside sources, as described in

§ 1008.33.

(2) The time period for issuing an

advisory opinion will be tolled from the

time that the OIG notifies the requestor

of the need for an outside expert

opinion until the time the OIG receives

the necessary expert opinion.

§ 1008.33 Expert opinions from outside

sources.

(a) The OIG may request expert advice

from qualified sources on non-legal

issues if necessary to respond to the

advisory opinion request. For example,

the OIG may require the use of

appropriate medical reviewers, such as

peer review organizations, to obtain

medical opinions on specific issues.

(b) If the OIG determines that it is

necessary to obtain expert advice to

issue a requested advisory opinion, the

OIG will notify the requestor of that fact

and provide the identity of the

appropriate expert and an estimate of

the costs of the expert advice. As

indicated in § 1008.31(e), the requestor

must pay the estimated cost of the

expert advice.

(c) Once payment is made for the cost

of the expert advice, the OIG will

arrange for a prompt expert review of

the issue or issues in question.

Subpart D—Submission of a Formal

Request for an Advisory Opinion

§ 1008.36 Submission of a request.

(a) A request for a formal advisory

opinion must be submitted in writing.

An original and 2 copies of the request
Federal Register / Vol. 62, No. 33 / Wednesday, February 19, 1997 / Rules and Regulations 7359

1The requestor is under an affirmative obligation

to make full and true disclosure with respect to the

facts regarding the advisory opinion being

requested.

should be addressed to the headquarter

offices of the OIG.

(b) Each request for an advisory

opinion must include—

(1) The identities, including the

names and addresses, of the requestor

and of all other actual and potential

parties, to the extent known to the

requestor to the arrangement that is the

subject of the request for an advisory

opinion;

(2) The name, title, address, and

daytime telephone number of a contact

person who will be available to discuss

the request for an advisory opinion with

the OIG on behalf of the requestor;

(3) A declaration of the subject

category or categories as described in

§ 1008.5 of this part for which the

advisory opinion is requested;

(4) A complete and specific

description of all relevant information

bearing on the arrangement for which an

advisory opinion is requested and on

the circumstances of the conduct,1

including—

(i) Background information,

(ii) Complete copies of all operative

documents, and

(iii) Detailed statements of all

collateral or oral understandings, if any;

(5) All Medicare and Medicaid

provider numbers used by all parties to

the arrangement;

(6) Signed certifications by the

requestor, as described in § 1008.37 of

this part; and

(7) A check or money order payable

to the Treasury of the United States in

the amount of $250, as discussed in

§ 1008.31(b) of this part.

§ 1008.37 Disclosure of ownership and

related information.

Each individual or entity requesting

an advisory opinion will supply full and

complete information as to the identity

of each entity owned or controlled by

the indivudual, and of each person with

an ownership or control interest in the

entity, as defined in section 1124(a)(1)

of the Social Security Act (42 U.S.C.

1320a–3(a)(1)) and part 420 of this

chapter.

§ 1008.38 Signed certifications by the

requestor.

(a) Every request must include the

following signed certification: ‘‘With

knowledge of the penalties for false

statements provided by 18 U.S.C. 1001

and with knowledge that this request for

an advisory opinion is being submitted

to the Department of Health and Human

Services, I certify that all of the

information provided is true and

correct, and constitutes a complete

description of the facts regarding which

an advisory opinion is sought, to the

best of my knowledge and belief.’’

(b) If the advisory opinion relates to

a proposed arrangement, the request

must also include the following signed

certification: ‘‘The arrangement

described in this request for an advisory

opinion is one that [the requestor] in

good faith plans to undertake.’’ This

statement may be made contingent on a

favorable OIG advisory opinion, in

which case, the phrase ‘‘if the OIG

issues a favorable advisory opinion’’

should be added to the certification.

(c) The certification(s) will be signed

by—

(1) The requestor, if the requestor is

an individual;

(2) The chief executive officer, or

comparable officer, of the requestor, if

the requestor is a corporation; or

(3) The managing partner of the

requestor, if the requestor is a

partnership.

§ 1008.39 Additional information.

(a) If the request for an advisory

opinion does not contain all of the

information required by § 1008.36 of

this part, or the OIG believes it needs

more information prior to rendering an

advisory opinion, the OIG may, at any

time, request whatever additional

information or documents it deems

necessary. The time period for the

issuance of an advisory opinion will be

tolled from the time the OIG requests

the additional information from the

requestor until such time as the OIG

determines that it has received the

requested information.

(b) The OIG may request additional

information before or after the request

for an advisory opinion has been

accepted.

(c) Additional information should be

provided in writing, signed by the same

person who signed the initial request

and certified by this person to be a true,

correct and complete disclosure of the

requested information in a manner

equivalent to that described in § 1008.37

of this part.

(d) In connection with any request for

an advisory opinion, the OIG or DoJ may

conduct whatever independent

investigation they believe appropriate.

§ 1008.40 Withdrawal.

The requestor of an advisory opinion

may withdraw the request prior to the

issuance of a formal advisory opinion by

the OIG. The withdrawal must be

written and must be submitted to the

same address as the submitted request,

as indicated in §§ 1008.18(b) and

1008.36(a) of this part. Regardless of

whether the request is withdrawn, the

requestor must pay the costs expended

by the OIG in processing the opinion, as

discussed in § 1008.31(d) of this part.

The OIG reserves the right to retain any

request for an advisory opinion,

documents and information submitted

to it under these procedures, and to use

them for any governmental purposes.

Subpart E—Obligations and

Responsibilities of the OIG

§ 1008.41 OIG acceptance of the request.

(a) Upon receipt of a request for an

advisory opinion, the OIG will promptly

make an initial determination of

whether the submission includes all of

the information the OIG will require to

process the request.

(b) Within 10 working days of receipt

of the request, the OIG will—

(1) Formally accept the request for an

advisory opinion,

(2) Notify the requestor of what

additional information is needed, or

(3) Decline to formally accept the

request.

(c) If the requestor provides the

additional information requested, or

otherwise resubmits the request, the

OIG will process the resubmission in

accordance with paragraphs (a) and (b)

of this section as if it was an initial

request for an advisory opinion.

(d) Upon acceptance of the request,

the OIG will notify the requestor by

regular U.S. mail of the date that the

request for the advisory opinion was

formally accepted.

(e) The 60-day period for issuance of

an advisory opinion set forth in

§ 1008.43(c) of this part will not

commence until the OIG has formally

accepted the request for an advisory

opinion.

§ 1008.43 Issuance of a formal advisory

opinion.

(a) An advisory opinion will be

considered issued, once payment is

received, when it is dated, numbered,

and signed by an authorized official of

the OIG.

(b) An advisory opinion will contain

a description of the material facts

known to the OIG with regard to the

arrangement for which an advisory

opinion has been requested. The

advisory opinion will state the OIG’s

opinion regarding the subject matter of

the request based on the facts provided

and known to the OIG.

(c)(1) The OIG will issue an advisory

opinion, in accordance with the

provisions of this part, within 60 days

after the request for an advisory opinion

has been formally accepted;
7360 Federal Register / Vol. 62, No. 33 / Wednesday, February 19, 1997 / Rules and Regulations

(2) If the 60th day falls on a Saturday,

Sunday, or Federal holiday, the time

period will end at the close of the

business day next following the

weekend or holiday;

(3) The 60 day period will be tolled

from the time the OIG—

(i) Notifies the requestor that the costs

have reached or are likely to exceed the

triggering amount until the time when

the OIG receives written notice from the

requestor to continue processing the

request;

(ii) Requests additional information

from the requestor until the time the

OIG receives the requested information;

(iii) Notifies the requestor of the full

amount due until the time the OIG

receives payment of the full amount

owed; and

(iv) Notifies the requestor of the need

for expert advice until the time the OIG

receives the expert advice.

(d) After the OIG has notified the

requestor of the full amount owed and

the OIG has received full payment of

that amount, the OIG will issue the

advisory opinion and promptly mail it

to the requestor by regular first class

U.S. mail.

§ 1008.45 Rescission.

Any advice given by the OIG is

without prejudice to the right of the OIG

to reconsider the questions involved

and, where the public interest requires,

to rescind or revoke the action. Notice

of such rescission or revocation will be

given to the requestor so that the

individual or entity may discontinue the

course of action taken in accordance

with the OIG advisory opinion. The OIG

will not proceed against the requestor

with respect to any action taken in good

faith reliance upon the OIG advice

under this part, where all the relevant

facts were fully, completely and

accurately presented to the OIG, and

where such action was promptly

discontinued upon notification of

rescission or revocation of the OIG

approval.

§ 1008.47 Disclosure.

(a) Advisory opinions issued and

released in accordance with the

provisions set forth in this part will be

available to the public.

(b) Promptly after the issuance and

release of an advisory opinion to the

requestor, a copy of the advisory

opinion will be available for public

inspection between the hours of 10:00

a.m. and 3:00 p.m. on normal business

days at the headquarter offices of the

OIG and on the DHHS/OIG web site.

(c) Any pre-decisional document, or

part of such pre-decisional document,

that is prepared in the OIG, DoJ or any

other Department or agency of the

United States in connection with an

advisory opinion request under the

procedures set forth in this part will be

exempt from disclosure under 5 U.S.C.

552, and will not be made publicly

available.

(d) Documents submitted by the

requestor to the OIG in connection with

a request for an advisory opinion will be

available to the public to the extent

authorized by 5 U.S.C. 552, through

procedures set forth in 45 CFR part 5.

(e) Nothing in this section will limit

the OIG’s right, in its discretion, to issue

a press release or otherwise publicly

disclose the identity of the requesting

party or parties, and the nature of the

action taken by the OIG upon the

request.

Subpart F—Scope and Effect of OIG

Advisory Opinions

§ 1008.51 Exclusivity of OIG advisory

opinions.

The only method for obtaining a

binding advisory opinion regarding any

of the subject matters set forth in

§ 1008.5(a) is through the procedures

described in this part. No binding

advisory opinion, oral or written, has or

may be issued by the OIG regarding the

specific matters set forth in § 1008.5(a)

except through written opinions issued

in accordance with this part.

§ 1008.53 Affected parties.

An advisory opinion issued by the

OIG will have no application to any

individual or entity that does not join in

the request for the opinion. No

individual or entity other than the

requestor(s) may rely on an advisory

opinion.

§ 1008.55 Admissibility of evidence.

(a) The failure of a party to seek an

advisory opinion may not be introduced

into evidence to prove that the party

intended to violate the provisions of

sections 1128, 1128A or 1128B of the

Act.

(b) An advisory opinion not issued to

a person may not be introduced into

evidence to prove that person did not

intend to violate the provisions of

sections 1128, 1128A or 1128B of the

Act.

§ 1008.59 Range of the advisory opinion.

(a) An advisory opinion will state

only the OIG’s opinion regarding the

subject matter of the request. If the

arrangement for which an advisory

opinion is requested is subject to

approval or regulation by any other

agency, such advisory opinion will not

be taken to indicate the OIG’s views on

the legal or factual issues that may be

raised before that agency.

(b) An advisory opinion issued under

this part will not bind or obligate any

agency other than the Department. It

will not affect the requestor’s, or anyone

else’s, obligations to any other agency,

or under any statutory or regulatory

provision other than that which is the

specific subject matter of the advisory

opinion.

Dated: December 26, 1996.

June Gibbs Brown,

Inspector General, Department of Health and

Human Services.

Approved: January 28, 1997.

Donna E. Shalala,

Secretary.

[FR Doc. 97–4086 Filed 2–18–97; 8:45 am]

BILLING CODE 4150–04–P

DEPARTMENT OF TRANSPORTATION

Coast Guard

46 CFR Part 199

[CGD 84–069]

RIN 2115–AB72

Lifesaving Equipment

AGENCY: Coast Guard, DOT.

ACTION: Interim rule, partial suspension;

request for comments.

SUMMARY: On May 20, 1996 the Coast

Guard published an interim rule

revising the lifesaving equipment

regulations for U.S. inspected vessels.

The interim rule included provisions for

vessels not on international routes to

comply with certain new requirements

by October 1, 1997 and October 1, 2001.

The Coast Guard has received comments

concerning the regulatory analysis for

the interim rule which may lead to

changes to the lifesaving requirements

in the final rule. To prevent any

economic expenditures based on the

interim rule which might not be

necessary under the final rule, the Coast

Guard is suspending the

implementation requirements for certain

provisions in the interim rule. The Coast

Guard requests comments on the

economic impacts of the lifesaving

requirements covered by the partial

suspension.

DATES: The suspension of § 199.10(i)(1)

(i), (ii) and (iii) is effective February 19,

1997. Comments must be received on or

before April 21, 1997.

ADDRESSES: Mail comments to the

Executive Secretary, Marine Safety

Council (G–LRA) [CGD 84–069], U.S.

Coast Guard Headquarters, 2100 Second