Federal Register / Vol. 63, No. 136 /Thursday, July 16, 1998 /Rules and Regulations 38309

These regulations will be effective on

that portion of Fiesta Bay and Mission

Bay, San Diego, California, that is

described in Table 1 of 33 CFR

100.1101. Implementation of 33 CFR

100.1101 is necessary to control vessel

traffic in the regulated area during the

event to ensure the safety of participants

and spectators.

Pursuant to 33 CFR 100.1101(a),

Commander, Coast Guard Activities San

Diego, is designated Patrol Commander

for this event; he has the authority to

delegate this responsibility to any

commissioned, warrant, or petty officer

of the Coast Guard.

DATES: This section is effective from

7:30 a.m. PDT until 6 p.m. PDT,

September 18, 1998, and continues to be

effective from 7:30 a.m. PDT until 6

p.m. PDT every day through, and

including, September 20, 1998. If the

event concludes prior to the scheduled

termination date and/or time, the Coast

Guard will cease enforcement of this

section and will announce that fact via

Broadcast Notice To Mariners.

FOR FURTHER INFORMATION CONTACT:

QMC Michael C. Claeys, U.S. Coast

Guard Activities San Diego, California;

Tel: (619) 683–6309.

SUPPLEMENTARY INFORMATION:

Discussion of Implementation

The World Series of Power Boat

Racing on Mission Bay is scheduled to

occur on September 18 and continues

daily through, and including, September

20, 1998. This event, formerly known as

the Thunderboat Regatta, consists of

racing using high-speed powerboats

with a maximum length of 27 feet.

Neither the sponsor, nor the date, nor

the location of the event has changed

since this event was listed as the

‘‘Thunderboat Regatta’’ in Table 1 of 33

CFR 100.1101.

These Special Local Regulations

permit Coast Guard control of vessel

traffic in order to ensure the safety of

spectator and participant vessels. In

accordance with the regulations in 33

CFR 100.1101, no persons or vessels

shall block, anchor, or loiter in the

regulated area; nor shall any person or

vessel transit through the regulated area,

or otherwise impede the transit of

participant or official patrol vessels in

the regulated area, unless cleared for

such entry by or through an official

patrol vessel acting on behalf of the

Patrol Commander.

Dated: June 25, 1998.

J.C. Card,

Vice Admiral, U.S. Coast Guard, Commander,

Eleventh Coast Guard District.

[FR Doc. 98–18947 Filed 7–15–98; 8:45 am]

BILLING CODE 4910–15–M

POSTAL SERVICE

39 CFR Part 111

Use and Determination of Postage

Value of Breast Cancer Research

Semi-postal Stamp

AGENCY: Postal Service.

ACTION: Final rule; request for

comments.

SUMMARY: This rule amends the

Domestic Mail Manual to establish the

terms and conditions for use and

determination of value of the Breast

Cancer Research Semi-postal Stamp.

DATES: Effective July 29, 1998.

Comments must be received on or

before August 17, 1998.

ADDRESSES: Mail or deliver written

comments to the Manager, Mail

Preparation and Standards, 475 L’Enfant

Plaza, SW, Room 6800, Washington, DC,

20260–2405. Copies of all written

comments will be available for

inspection and photocopying between 9

a.m. and 4 p.m., Monday through Friday

at USPS Headquarters Library, 475

L’Enfant Plaza SW, 11th Floor N,

Washington, DC.

FOR FURTHER INFORMATION CONTACT:

Anne Emmerth, (202) 268–2363.

SUPPLEMENTARY INFORMATION: The

Stamp Out Breast Cancer Act, Pub. L.

No. 105–41, 111 Stat. 1119 (1997),

directs the Postal Service to make

available a Breast Cancer Research

Semi-postal Stamp at a special price to

enable the public to make contributions

to fund breast cancer research. The Act

specifies that the price of the special

postage stamp is the First-Class Mail

single-piece first-ounce letter rate plus a

differential not to exceed 25 percent of

that rate category. The Act empowers

the Governors of the United States

Postal Service to establish the price for

the stamp. Pursuant to the Act, the

Governors have established a price of 40

cents for each Breast Cancer Research

Semi-postal Stamp.

Mailers may use the Breast Cancer

Research Semi-postal Stamp in place of

First-Class Mail single-piece first-ounce

letter rate stamps on their mail, if they

so choose, in order to make a

contribution. The difference between

the purchase price of the stamp (40

cents) and the First-Class Mail singlepiece first-ounce letter rate (currently 32

cents) less associated costs will be used

to fund breast cancer research. Pursuant

to the Act, the Postal Service is directed

to pay, after deduction for its reasonable

costs, 70 percent of the revenue from the

differential to the National Institutes of

Health, and the remainder to the

Department of Defense.

The stamp’s dual purposes, namely,

as a means of payment of postage and

as a device for raising funds for breast

cancer research, require that special

terms and conditions apply to the use of

the stamp. In particular, because the

stamp must be made available for a twoyear period, and given that the Act does

not require that the stamp’s price be

changed in the event that a change in

the First-Class Mail single-piece rate is

implemented during the two-year

period, the Postal Service has

determined that the stamp will be nondenominated. This measure preserves

the Governors’ option of maintaining

the price of the Breast Cancer Research

Semi-postal Stamp at 40 cents, even

after the First-Class Mail single-piece

rate is raised to 33 cents after the

stamp’s issuance, without the need to

reprint the stamp with a new numerical

denomination. When the First-Class

Mail single-piece rate is increased to 33

cents on January 10, 1999, the postage

value of Semi-postal stamps purchased

before such change is effected will

remain the same. Stamps purchased

after a change in the First-Class Mail

single-piece rate is effected will have a

postage value equivalent to that rate at

the time of purchase. Thus, Semi-postal

stamps purchased before the First-Class

Mail single-piece rate is changed on

January 10, 1999, will have a postage

value of $0.32; Semi-postal stamps

purchased after the rate change is

implemented will have a postage value

of $0.33.

In lieu of a numerical denomination,

the stamp will bear the words ‘‘FirstClass.’’ This measure is intended to

inform mailers that the stamp’s postage

value is equal to the First-Class Mail

single-piece letter rate in effect at the

time of purchase. In addition, the

Domestic Mail Manual distinguishes the

price of the stamp from its postage value

and establishes that the postage value of

the stamp is determined by the FirstClass Mail first-ounce single-piece letter

rate in effect at the time of purchase.

Conforming limitations on refunds

and valuation for purposes of exchange

or conversion are also included in the

final rule. A conforming amendment is

also made to DMM R000.4.0.

Although exempt from the notice and

comment requirements of the

Administrative Procedure Act (5 U.S.C.

553(b), (c)) regarding rulemaking by 39

U.S.C. 410(a), the Postal Service is

seeking comments on the following

revisions of the Domestic Mail Manual

(DMM), incorporated by reference in the

Code of Federal Regulations. See 39 CFR

part 111.
38310 Federal Register / Vol. 63, No. 136 /Thursday, July 16, 1998 /Rules and Regulations

List of Subjects in 39 CFR Part 111

Postal Service.

Accordingly, 39 CFR 111 is amended

as follows:

PART 111—[AMENDED]

1. The authority citation for 39 CFR

part 111 is amended to read as follows:

Authority: 5 U.S.C. 552(a); 39 U.S.C. 101,

401, 403, 414, 3001–3011, 3201–3219, 3403–

3406, 3621, 3626, 5001.

2. Revise the following sections of the

Domestic Mail Manual as set forth

below:

P Postage and Payment Methods

* * * * *

P014 Refunds and Exchanges

1.0 STAMP EXCHANGES

1.1 USPS Fault

[Amend to read:]

The post office may correct mistakes

in selling damaged, defective, or

otherwise unserviceable stamps by

exchanging stamps at full postage value.

1.2 Damaged in Customer’s Possession

[Amend the last sentence to read as

follows:]

* * * Each such transaction is

limited to $100 worth of postage from

each customer.

* * * * *

1.5 Purchase Error

[Amend the first sentence to read as

follows:]

If a customer bought the wrong

denomination stamps (or the wrong

kind, size, or denomination envelope),

they may be exchanged at full postage

value. * * *

* * * * *

2.0 POSTAGE AND FEES REFUNDS

* * * * *

[Add new 2.10 to read as follows:]

2.10 Breast Cancer Research Semipostal Stamps

Customers may exchange or convert

Breast Cancer Research Semi-postal

Stamps for their postage value, i.e., the

price of the stamps less the contribution

amount, to the extent exchange or

conversion of postage stamps is

permitted under P014. The postage

exchanged or converted is equivalent to

the First-Class Mail single-piece rate in

effect at the time of purchase (currently

$0.32), as supported by the mailer’s

receipt. The contribution amount is not

included in the exchange or conversion

value. If the mailer cannot produce a

receipt, the exchange or conversion

value of each Breast Cancer Research

Semi-postal Stamp cannot exceed $0.32

per stamp, regardless of whether the

First-Class Mail single-piece rate in

effect at the time of purchase is $0.33 or

higher.

* * * * *

P020 Postage Stamps and Stationery

P022 Adhesive Stamps

1.0 PURCHASE AND USE

* * * * *

[Create 1.6 to read as follows:]

1.6 Breast Cancer Research Semipostal Stamps

Breast Cancer Research Semi-postal

Stamps are subject to special limitations

and conditions:

a. Breast Cancer Research Semi-postal

Stamps provide a means for customers

to make contributions toward breast

cancer research. Breast Cancer Research

Semi-postal Stamps are offered for sale

for a limited time as provided under 39

U.S.C. 414.

b. The price of the Breast Cancer

Research Semi-postal Stamp is 40 cents.

The postage value of the Breast Cancer

Research Semi-postal Stamp is the FirstClass Mail Nonautomation Single-Piece

first-ounce letter rate in R100.1.2 that is

in effect at the time of purchase. The

difference between the purchase price

and the First-Class Mail Nonautomation

Single-Piece first-ounce letter rate in

effect at the time of purchase constitutes

a contribution to breast cancer research,

and cannot be used to pay postage.

Additional postage must be affixed to

pieces weighing in excess of one ounce,

pieces subject to the nonstandard

surcharge, or pieces for which special

services have been elected. The postage

value of Breast Cancer Research Semipostal Stamps is fixed according to the

First-Class Mail Nonautomation SinglePiece first-ounce letter rate in effect at

the time of purchase; the postage value

of Breast Cancer Research Semi-postal

Stamps purchased before any

subsequent change in the First-Class

Mail Nonautomation Single-Piece firstounce letter rate is unaffected by any

subsequent change in that rate.

c. Contributions to breast cancer

research made through purchase of

Breast Cancer Research stamps are not

refundable. The postage value of Breast

Cancer Research stamps for purposes of

exchange or conversion under P014 is

determined by the First-Class Mail

Nonautomation Single-Piece rate in

effect at the time of purchase, or as

otherwise provided in P014.2.10.

* * * * *

R Rates and Fees

R000 Stamps and Stationery

* * * * *

[Amend the table in R000.4.0 to

include the following line item:]

Purpose Form Denomination

* * * * * * *

Breast Cancer Research.

Panes of up to 20 ....... Purchase Price of $0.40; Postage Value Equivalent to First-Class Mail Nonautomation Single-Piece Rate (currently $0.32); remainder is contribution to fund Breast Cancer Research.
Federal Register / Vol. 63, No. 136 /Thursday, July 16, 1998 /Rules and Regulations 38311

1Public Law 104–191 erroneously cited this

provision as section 1128B(b) of the Act. Section

4331(a) of the Balanced Budget Act of 1997, Public

Law 105–33, corrected this citation to section

1128A(b) of the Act.

2Any individual or entity may submit a request

for an advisory opinion. However, we anticipate

that most requests will apply to health care

business arrangements. Therefore, for purposes of

this discussion, we will generally use the term

‘‘arrangement’’ to refer to the factual circumstances

about which an advisory opinion is requested, even

though we realize that some requests will involve

facts not related to a business arrangement.

* * * * *

An appropriate amendment to 39 CFR

111.3 will be published to reflect these

changes.

Stanley F. Mires,

Chief Counsel, Legislative.

[FR Doc. 98–19017 Filed 7–15–98; 8:45 am]

BILLING CODE 7710–12–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: Final rule.

SUMMARY: In accordance with section

205 of the Health Insurance Portability

and Accountability Act of 1996, this

final rule sets forth the specific

procedures by which the Department,

through the Office of Inspector General

(OIG), in consultation with the

Department of Justice (DoJ), will issue

advisory opinions to outside parties

regarding the interpretation and

applicability of certain statutes relating

to the Federal and State health care

programs. The procedures for

submitting a request and obtaining an

advisory opinion from the OIG were

established through interim final

regulations published in the Federal

Register on February 19, 1997. In

response to public comments received

on these interim final regulations, this

final rule revises and clarifies various

aspects of the earlier rulemaking.

EFFECTIVE DATE: This rule is effective on

July 16, 1998.

FOR FURTHER INFORMATION CONTACT: Joel

Schaer, (202) 619–0089, OIG

Regulations Officer.

SUPPLEMENTARY INFORMATION:

I. Background

A. Section 205 of Public Law 104–191

The Health Insurance Portability and

Accountability Act of 1996 (HIPAA),

Public Law 104–191, specifically

required the Department to provide a

formal guidance process to requesting

individuals and entities regarding the

application of the anti-kickback statute,

the safe harbor provisions, and other

OIG health care fraud and abuse

sanctions. In accordance with section

205 of HIPAA, the Department, in

consultation with the DoJ, issues written

advisory opinions to 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 (the Act), or

established by regulation, for activities

which do not result in prohibited

remuneration; (3) what constitutes an

inducement to reduce or limit services

to Medicare or Medicaid program

beneficiaries under section 1128A(b) of

the Act 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 may be issued with regard to

the criminal provisions of section 1128B

of the Act, which includes the antikickback statute, as well as the

provisions of section 1128 of the Act,

which authorizes the Department to

exclude individuals and entities from

participation in Federal and State health

care programs. Exclusions are

authorized in a wide variety of

circumstances, including, for example,

conviction of health care related

offenses, State licensure action, and

submission of claims in excess of usual

charges or for services that fail to meet

professionally recognized standards of

health care. In addition, advisory

opinions are available regarding the

civil money penalty provisions of

section 1128A of the Act, which

authorizes penalties for a variety of acts,

including, among others, presentation of

a false or fraudulent Medicare or

Medicaid claim and hospital payments

to physicians to induce them to reduce

or limit care to any Medicare or

Medicaid beneficiary under their direct

care.

B. OIG Interim Final Regulations

Because HIPAA required that specific

procedures and final regulations on the

advisory opinion process be in place by

February 21, 1997, the Secretary

determined that it was both

impracticable and contrary to the public

interest to first issue regulations in

proposed rulemaking form. As a result,

on February 19, 1997, the OIG

published interim final regulations (62

FR 7350) establishing a new part 1008

in 42 CFR chapter V addressing the

various procedural issues and aspects of

the advisory opinion process.

Specifically, the interim final rule set

forth (1) the procedures to be followed

by parties applying for advisory

opinions and by the OIG in responding

to these requests; (2) the time frames

pursuant to which the OIG will receive

and respond to requests; (3) the type

and amount of fees to be charged to

requesting parties; and (4) the manner in

which the public will be informed of the

issuance of any advisory opinions.

The interim final rule also set forth a

60-day public comment period for

specific comments and

recommendations for refining the

advisory opinion process.

C. Summary of the Interim Final Rule

The establishment of a new part 1008

in 42 CFR chapter V specifically

addressed, among other provisions, the

following procedural aspects of the

advisory opinion process:

1. Responsibilities of Outside Parties

Section 1008.15 of the interim final

rule indicated that any individual or

entity may submit a request for an

advisory opinion, but that the

arrangement in question must, at the

time of the request for an opinion, either

be in existence or be an arrangement

into which the parties have a good faith

intention to enter in the future.2 Section

1008.15(b) stated that requests

presenting general questions of

interpretation, posing hypothetical

situations, or seeking an opinion about

the activities of third parties would not

qualify for advisory opinions. Section

1008.11 stated that the OIG would not

provide advisory opinions to persons

not involved directly in the

arrangement. In addition, §§ 1008.53

and 1008.55(b) of the rule stated that an

advisory opinion would be legally

binding on the Department and the

requesting party only with respect to the

specific conduct of the requesting party;

it would not be legally binding with

respect to third party conduct, even if

such conduct appears similar to the

conduct of the initial requestor.

Section 1008.36 of the interim final

rule indicated that a request for an

advisory opinion must be submitted to

the OIG in written form and must

present all facts relevant to the subject

matter for which the opinion is being

requested. Section 1008.37 provided

that all parties and potential parties to

the arrangement must be identified.