[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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