[Federal Register Volume 73, Number 138 (Thursday, July 17, 2008)]
[Rules and Regulations]
[Pages 40982-40983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-15777]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

42 CFR Part 1008


Office of Inspector General; 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.

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SUMMARY: OIG is adopting in final form, without change, an interim 
final rule published on March 26, 2008 (73 FR 15937). We received no 
comments to the interim final rule. The interim final rule revised the 
process for advisory opinion requestors to submit payments for advisory 
opinion costs.

DATES: Effective Date: This final rule is effective as of July 17, 
2008.

FOR FURTHER INFORMATION CONTACT: Meredith Melmed, Office of Counsel to 
the Inspector General, (202) 619-0335.

SUPPLEMENTARY INFORMATION: 

I. Background

    The Health Insurance Portability and Accountability Act of 1996 
(HIPAA), Public Law 104-101, specifically required the Department of 
Health and Human Services (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. OIG published an 
interim final rule (62 FR 7350; February 19, 1997) establishing a new 
part 1008 in 42 CFR chapter V addressing various procedural issues and 
aspects of the advisory opinion process. In response to public comments 
received on the interim final regulations, we published a final rule 
(63 FR 38311; July 16, 1998) revising and clarifying various aspects of 
the earlier rulemaking. The rulemaking established procedures for 
requesting an advisory opinion. Specifically, the rule provided 
information to the public regarding costs associated with preparing an 
opinion and procedures for submitting an initial deposit and final 
payment to OIG for such costs.

II. Interim Final Rule With Comment Period and Final Rule

    On March 26, 2008, OIG published an interim final rule amending 42 
CFR chapter V, subchapter B (73 FR 15937). The comment period ended on 
April 25, 2008 and no comments were received. Accordingly, OIG is 
adopting the interim final rule as a final rule with no modifications.

[[Page 40983]]

    The interim final rule modified the procedures for submitting an 
advisory opinion request by deleting the requirements at Sec.  
1008.31(b) and 1008.36(b)(6) for an initial payment of $250 for each 
advisory opinion request, and amending Sec.  1008.31(b) to require that 
payment for an advisory opinion be made directly to the Treasury of the 
United States, as directed by OIG. In addition, we amended Sec.  
1008.43(d) to state that an advisory opinion will be issued following 
receipt by OIG of confirmation that payment in full has been remitted 
by the requesting party to the Department of Treasury, as directed by 
OIG. We also notified the public that, as of the effective date of the 
interim final rule, we no longer would accept checks or money orders 
from requesting parties and payments must be made directly to the 
United States Treasury through wire or other electronic funds transfer. 
We provided additional instructions to the public on our Web site 
(www.oig.hhs.gov) for paying fees owed for advisory opinions via wire 
or other electronic funds transfer.

III. Regulatory Impact Statement

A. Administrative Procedure Act

    The advisory opinion process is an established OIG program. This 
final rule is limited to modifying the processing of payments received 
for advisory opinion requests. It does not modify eligibility of a 
party to request an advisory opinion, nor does it modify the standards 
under which OIG will accept and/or analyze a request. OIG expects that 
this final rule will further the public's interest with minimal burden 
by confirming the interim final rule, which deleted the requirement for 
an initial payment of a deposit to be credited toward the final 
advisory opinion processing costs, and by requiring the use of 
electronic transfers of funds. This final rule will also provide 
greater efficiency in processing payments from requestors and will save 
staff time.

B. Regulatory Analysis

    We have examined the impact of this final rule as required by 
Executive Order 12866, the Regulatory Flexibility Act (RFA) of 1980, 
the Unfunded Mandates Reform Act of 1995, and Executive Order 13132.
Executive Order 12866 and Regulatory Flexibility Act
    As discussed above, these regulations were published as an interim 
final rule on March 26, 2008. Because no notice of proposed rulemaking 
was required, the provisions of the RFA do not apply. Further, this 
document does not meet the criteria for a significant regulatory action 
as specified in Executive Order 12866.
Unfunded Mandates Reform Act
    Section 202 of the Unfunded Mandates Reform Act of 1995, Public Law 
104-4, requires that agencies assess anticipated costs and benefits 
before issuing any rule that may result in expenditures in any one year 
by State, local, or tribal governments, in the aggregate, or by the 
private sector, of $100 million or more (adjusted annually for 
inflation). We believe that this final rule will not impose any 
mandates on State, local, or tribal governments or the private sector 
that would result in an expenditure of $100 million or more (adjusted 
for inflation) in any given year, and that a full analysis under the 
Unfunded Mandates Reform Act is not necessary.
Executive Order 13132
    Executive Order 13132, Federalism, establishes certain requirements 
that an agency must meet when it promulgates a rule that imposes 
substantial direct requirements or costs on State and local 
governments, preempts State law, or otherwise has Federalism 
implications. In reviewing this final rule under the threshold criteria 
of Executive Order 13132, Federalism, we have determined that this 
final rule would not significantly limit the rights, roles, and 
responsibilities of State or local governments. We have determined, 
therefore, that a full analysis under Executive Order 13132 is not 
necessary.

C. Paperwork Reduction Act

    In accordance with section 3506(c)(2)(A) of the Paperwork Reduction 
Act of 1995, we are required to solicit public comments, and receive 
final OMB approval, on any information collection requirements set 
forth in rulemaking. This final rule will not impose any information 
collection burden or affect information currently collected by OIG.
    Accordingly, the interim final rule amending 42 CFR chapter V, 
subchapter B, which was published in the Federal Register at 73 FR 
15937 on March 26, 2008, is adopted as a final rule without change.

    Dated: July 3, 2008.
Daniel R. Levinson,
Inspector General.
    Approved: July 3, 2008.
Michael O. Leavitt,
Secretary.
 [FR Doc. E8-15777 Filed 7-16-08; 8:45 am]
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