Federal Register / Vol. 62, No. 173 / Monday, September 8, 1997 / Proposed Rules 47195

(b) In making the reinstatement

determination, the OIG will consider—

* * * * *

(3) Whether all fines, and all debts

due and owing (including

overpayments) to any Federal, State or

local government that relate to Medicare

or any of the State health care programs,

have been paid or satisfactory

arrangements have been made to fulfill

these obligations; and

(4) Whether HCFA has determined

that the individual or entity complies

with, or has made satisfactory

arrangements to fulfill, all of the

applicable conditions of participation or

supplier conditions for coverage under

the statutes and regulations.

(c) If the OIG determines that the

criteria in paragraphs (a)(1) (ii) and (iii)

of this section have been met, an entity

excluded in accordance with

§ 1001.1001 will be reinstated upon a

determination by the OIG that the

individual whose conviction, exclusion

or civil money penalty was the basis for

the entity’s exclusion—

* * * * *

(d) If the OIG determines that the

criteria in paragraphs (a)(1) (ii) and (iii)

of this section have been met, an

individual excluded in accordance with

§ 1001.1051 will be reinstated upon a

determination with paragraph (a) of this

section of § 1001.3005.

(e) Reinstatement will not be effective

until the OIG grants the request and

provides notice under § 1001.3003(a) of

this part. Reinstatement will be effective

as provided in the notice.

(f) A determination with respect to

reinstatement is not appealable or

reviewable except as provided in

§ 1001.3004.

(g) An ALJ may not require

reinstatement of an individual or entity

in accordance with this chapter.

C. Part 1002 would be amended as

follows:

PART 1002—[AMENDED]

1. The authority citation for part 1002

would continue to read as follows:

Authority: 42 U.S.C. 1302, 1320a–3,

1320a–5, 1320a–7, 1396(a)(4)(A), 1396(p)(1),

1396a(30), 1396a(39) 1396b(a)(6),

1396b(b)(3), 1396b(i)(2) and 1396b(q).

2. Section 1002.3 would be amended

by revising paragraph (b)(2) and by

adding a new paragraph (b)(3) to read as

follows:

§ 1002.3 Disclosure by providers;

information on persons convicted of

crimes.

* * * * *

(b) Notification to Inspector General.

* * *

(2) The agency must promptly notify

the Inspector General of any action it

takes on the provider’s application for

participation in the program.

(3) The agency must also promptly

notify the Inspector General of any

action it takes to limit the ability of an

individual or entity to participate in its

program, regardless of what such an

action is called. This includes, but is not

limited to, suspension actions,

settlement agreements and situations

where an individual or entity

voluntarily withdraws from the program

to avoid a formal sanction.

* * * * *

3. Section 1002.203 would be

amended by revising paragraph (a) to

read as follows:

§ 1002.203 Mandatory exclusion.

(a) The State agency, in order to

receive Federal financial participation

(FFP), must provide that it will exclude

from participation any HMO, or entity

furnishing services under a waiver

approved under section 1915(b)(1) of

the Act, if such organization or entity—

(1) Could be excluded under

§§ 1001.1001 or 1001.1051 of this

chapter, or

(2) Has, directly or indirectly, a

substantial contractual relationship with

an individual or entity that could be

excluded under §§ 1001.1001 or

1001.1051 of this chapter.

* * * * *

4. Section 1002.211 would be

amended by revising paragraph (a) to

read as follows:

§ 1002.211 Effect of exclusion.

(a) Denial of payment. Except as

provided for in § 1001.1901 (c)(3), (c)(4)

and (c)(5)(i) of this chapter, no payment

may be made by the State agency for any

item or service furnished on or after the

effective date specified in the notice by

an excluded individual or entity, or at

the medical direction or on the

prescription of a physician who is

excluded when a person furnishing

such item or service knew, or had

reason to know, of the exclusion.

PART 1005—[AMENDED]

D. Part 1005 would be amended as

follows:

1. The authority citation for part 1005

would continue to read as follows:

Authority: 42 U.S.C. 405(a), 405(b), 1302,

1320a–7, 1320a–7a and 1320c–5.

2. Section 1005.15 would be amended

by revising introductory paragraph (f)(1)

to read as follows:

§ 1005.15 The hearing and burden of

proof.

* * * * *

(f)(1) A hearing under this part is not

limited to specific items and

information set forth in the notice letter

to the petitioner or respondent. Subject

to the 15-day requirement under

§ 1005.8, additional items and

information, including aggravating or

mitigating circumstances that arose or

became known subsequent to the

issuance of the notice letter, may be

introduced by either party during its

case-in-chief unless such information or

items are—

* * * * *

Dated: March 13, 1997.

June Gibbs Brown,

Inspector General, Department of Health and

Human Services.

Approved: June 18, 1997.

Donna E. Shalala,

Secretary.

[FR Doc. 97–23379 Filed 9–5–97; 8:45 am]

BILLING CODE 4150–04–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of Inspector General

42 CFR Part 1001

Negotiated Rulemaking Committee on

the Shared Risk Exception; Meetings

AGENCY: Office of Inspector General

(OIG), HHS.

ACTION: Meeting of Negotiated

Rulemaking Committee.

SUMMARY: In accordance with the

Federal Advisory Committee Act, this

document announces the dates and

location for the fourth and fifth set of

meetings by the Negotiated Rulemaking

Committee on the Shared Risk

Exception. The purpose of this

committee is to negotiate the

development of an interim final rule

addressing the shared risk exception to

the Federal health care programs’ antikickback provisions, as statutorilymandated by section 216 of the Health

Insurance Portability and

Accountability Act of 1996.

DATES: The fourth series of meetings

will be held from 9:00 a.m. to 5:00 p.m.

on October 8 and 9, 1997, and from 9:00

a.m. to 2:00 p.m. on October 10, 1997.

The fifth series of meetings will be held

from 9:00 a.m. to 5:00 p.m. on

November 19, 20 and 21, 1997.

ADDRESSES: The October meeting will be

held in the OIG Conference Room,

Room 5542, Cohen Building, 330

Independence Avenue, S.W.,
47196 Federal Register / Vol. 62, No. 173 / Monday, September 8, 1997 / Proposed Rules

Washington, D.C. 20201. The November

meeting will be held in Rooms 383 and

385, Hall of States Building of the

National Association of Insurance

Commissioners, 444 North Capitol

Street, N.W., Washington, D.C. 20001.

FOR FURTHER INFORMATION CONTACT:

Inquiries regarding these meetings

should be addressed to Joel Schaer, OIG

Regulations Officer, Office of Counsel to

the Inspector General, Room 5518,

Cohen Building, 330 Independence

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

or call (202) 619–0089.

SUPPLEMENTARY INFORMATION: The

Negotiated Rulemaking Committee on

the Shared Risk Exception has been

established to provide advice and make

recommendations to the Secretary of

Health and Human Services with

respect to the text or content of an

interim final rule that will establish

standards relating to the exception to

the anti-kickback statute for risk-sharing

arrangements, set forth in section

1128B(b)(3)(F) of the Social Security

Act. The exception was enacted by

section 216 of Public Law 104–191, the

Health Insurance Portability and

Accountability Act (HIPAA) of 1996.

Section 216 of HIPAA provides that the

Secretary will promulgate regulations

that establish standards for the

exception using an expedited negotiated

rulemaking process.

The intent to form the negotiated

rulemaking committee and the dates for

the first two series of meetings held in

June and July 1997 were announced in

the Federal Register on May 23, 1997

(62 FR 28410). The third series of

meetings is scheduled for September 9

and 10, 1997 (see 62 FR 39798 for times

and location of the September

meetings).

During the scheduled October and

November meetings, the committee will

continue to discuss issues relating to the

development of the interim final rule

and to generate and discuss options for

resolving those issues.

The meetings will be open to the

public without advanced registration.

Public attendance at the October

meeting may be limited to space

available. Members of the public

wishing to attend the October sessions

may want to notify the contact person

listed above in advance to expedite

access to the Cohen Building. A

summary of all proceedings of these

meetings and relevant matters and other

material will also be available for public

inspection at the address listed above

from the hours of 8:30 a.m. to 5:00 p.m.,

or can be accessed through the OIG web

site (http://www.sbaonline.sba.gov/

ignet/internal/hhs/hhs.html).

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. App. 2).

Dated: August 27, 1997.

June Gibbs Brown,

Inspector General.

[FR Doc. 97–23530 Filed 9–5–97; 8:45 am]

BILLING CODE 4150–04–P