Medicare and State Health Care Programs: Fraud and Abuse; Issuance of Advisory Opinions by OIG, 15937-15939 [E8-6164]
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Federal Register / Vol. 73, No. 59 / Wednesday, March 26, 2008 / Rules and Regulations
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[FR Doc. E8–6205 Filed 3–25–08; 8:45 am]
BILLING CODE 6560–50–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Office of Inspector General
42 CFR Part 1008
Medicare and State Health Care
Programs: Fraud and Abuse; Issuance
of Advisory Opinions by OIG
Office of Inspector General
(OIG), HHS.
ACTION: Interim final rule with comment
period.
sroberts on PROD1PC70 with RULES
AGENCY:
SUMMARY: In accordance with section
205 of the Health Insurance Portability
and Accountability Act of 1996, this
final rule amends the OIG regulations at
42 CFR part 1008 by (1) revising the
process for advisory opinion requestors
to submit payments for advisory
opinion costs, and (2) clarifying that
notices to the public announcing
procedures for processing advisory
opinion requests will be published on
OIG’s Web site.
DATES: Effective Date: These regulations
are effective on April 25, 2008.
Comment Period: To assure
consideration, public comments must be
delivered to the address provided below
by no later than 5 p.m. on April 25,
2008.
ADDRESSES: In commenting, please refer
to file code OIG–223–IFC. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
three ways (no duplicates, please):
VerDate Aug<31>2005
16:40 Mar 25, 2008
Jkt 214001
1. Electronically. You may submit
electronic comments on specific
recommendations and proposals
through the Federal eRulemaking Portal
at https://www.regulations.gov.
(Attachments should be in Microsoft
Word, if possible.)
2. By regular, express, or overnight
mail. You may send written comments
to the following address: Office of
Inspector General, Department of Health
and Human Services, Attention: OIG–
223–IFC, Room 5246, Cohen Building,
330 Independence Avenue, SW.,
Washington, DC 20201. Please allow
sufficient time for mailed comments to
be received before the close of the
comment period.
3. By hand or courier. If you prefer,
you may deliver, by hand or courier,
your written comments before the close
period to Office of Inspector General,
Department of Health and Human
Services, Cohen Building, 330
Independence Avenue, SW.,
Washington, DC 20201. Because access
to the interior of the Cohen Building is
not readily available to persons without
Federal Government identification,
commenters are encouraged to schedule
their delivery with one of our staff
members at (202) 358–3141.
For information on viewing public
comments, please see section IV in the
SUPPLEMENTARY INFORMATION section
below.
FOR FURTHER INFORMATION CONTACT:
Meredith Melmed, Office of Counsel to
the Inspector General, (202) 619–0335.
SUPPLEMENTARY INFORMATION:
I. Background
A. Section 205 of Public Law 104–191
The Health Insurance Portability and
Accountability Act of 1996 (HIPAA),
Public Law 104–101, 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 Department of
Justice, 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
PO 00000
Frm 00077
Fmt 4700
Sfmt 4700
15937
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.
B. OIG Final Regulations
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. Provisions of the Interim Final Rule
By statute, the Department must
charge a fee equal to the costs incurred
by the Department in responding to a
request for an advisory opinion. (42
U.S.C. 1320a–7d(b)(5)(B)(ii)). Under the
interim final and final advisory opinion
rules, we directed requestors to make an
initial payment to the U.S. Treasury by
check or money order in the amount of
$250. The regulations have also allowed
for the acceptance of final payment of
the fee by check or money order.
Through this interim final rule, we are
setting forth several revisions to the
payment process for advisory opinion
requests. Specifically, we are modifying
our procedures for submitting an
advisory opinion request by deleting the
current requirements at §§ 1008.31(b)
and 1008.36(b)(6) for an initial payment
of $250 for each advisory opinion
request, and replacing the existing
provision set forth in § 1008.31(b) with
a requirement that payment for an
advisory opinion be made directly to the
Treasury of the United States, as
directed by OIG. In addition, we are
amending § 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.
1 Public 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.
E:\FR\FM\26MRR1.SGM
26MRR1
15938
Federal Register / Vol. 73, No. 59 / Wednesday, March 26, 2008 / Rules and Regulations
A. Electronic Payment Directly to the
U.S. Treasury
As of the effective date of this rule, we
will no longer accept checks or money
orders from requesting parties and will
require payments to be made directly to
the United States Treasury through wire
or other electronic funds transfer.
Changing the requirement that payment
be made by check or money order to
provide for wire or other electronic
funds transfers will create efficiencies in
processing payments for advisory
opinion requests, reduce the use of staff
resources to process such payments, and
reduce the burden on requesting parties.
B. Elimination of Initial Deposit
We are also eliminating the initial
deposit payment from the requirements
for submitting an advisory opinion
request. A deposit is not required by
statute. We believe that deleting the
initial deposit payment will further
streamline the electronic payment
process and will eliminate
administrative burdens that may arise if
an initial deposit must be returned. For
instance, where parties erroneously
submit requests that are wholly outside
our authority to issue an advisory
opinion, such as requests regarding
issues arising under the physician selfreferral law (42 U.S.C. 1395nn),
returning funds submitted directly to
the Department of Treasury would be
cumbersome. In addition, eliminating
the initial deposit requirement will
reduce the burden on requesting parties
by consolidating the parties’ payment
obligations into one final payment. We
will provide additional instructions to
the public on our Web site (https://
www.oig.hhs.gov) for paying fees owed
for advisory opinions via wire or other
electronic funds transfer.
sroberts on PROD1PC70 with RULES
III. Regulatory Impact Statement
A. Administrative Procedure Act
OIG has determined that the public
notice and comment requirements of the
Administrative Procedure Act, 5 U.S.C.
553(b), do not apply to this rule because
the rule is procedural in nature and
does not alter the substantive rights of
the affected parties. Therefore, this rule
satisfies the exemption from notice and
comment rulemaking in 5 U.S.C.
553(b)(A). OIG nevertheless invites
comments on this rule and will consider
all timely submitted comments.
The advisory opinion process is an
established OIG program. This 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
VerDate Aug<31>2005
16:40 Mar 25, 2008
Jkt 214001
which OIG will accept and/or analyze a
request. OIG expects that this rule will
further the public’s interest in minimal
burden by deleting the requirement for
an initial payment of a deposit to be
credited toward the final advisory
opinion processing costs and by
allowing the use of electronic transfers
of funds. The 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
rule as required by Executive Order
12866, the Unfunded Mandates Reform
Act of 1995, the Regulatory Flexibility
Act (RFA) of 1980, and Executive Order
13132.
Executive Order 12866
Executive Order 12866 directs
agencies to assess all costs and benefits
of available regulatory alternatives and,
if regulations are necessary, to select
regulatory approaches that maximize
net benefits (including potential
economic, environmental, public health,
and safety effects; distributive impacts;
and equity). A regulatory impact
analysis must be prepared for major
rules with economically significant
effects (i.e., $100 million or more in any
given year).
This is not a major rule, as defined at
5 U.S.C. 804(2), and it is not
economically significant since the
overall economic effect of the rule is
less than $100 million annually. As
indicated in Section II of this preamble,
this rule deals exclusively with the
procedural issues involved in the
payment for advisory opinions issued
by OIG. This rule does not address the
substance of the anti-kickback statute or
other sanction statutes. This rule does
not change any costs associated with
requesting an advisory opinion, but,
rather, clarifies the procedures for
submitting statutorily-mandated
payment for costs incurred preparing an
advisory opinion. We believe that the
aggregate economic impact of this rule
will be minimal and will have no effect
on the economy or on Federal or State
expenditures. To the extent that there is
any economic impact, that impact will
likely result in savings of Federal
dollars through the improved
efficiencies in the use of staff resources
for processing advisory opinion requests
and payments related to advisory
opinion requests, as well as savings for
parties that request advisory opinions.
Unfunded Mandates Reform Act
Section 202 of the Unfunded
Mandates Reform Act of 1995, Public
PO 00000
Frm 00078
Fmt 4700
Sfmt 4700
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
$110 million. Since the rule merely
revises the process for paying for
advisory opinions and creates greater
efficiencies in processing payments, we
believe that this rule that will not
impose any mandates on State, local, or
tribal governments or the private sector
that would result in an expenditure of
$110 million or more (adjusted for
inflation) in any given year, and that a
full analysis under the Unfunded
Mandates Reform Act is not necessary.
Regulatory Flexibility Act
The RFA and the Small Business
Regulatory Enforcement and Fairness
Act of 1996, which amended the RFA,
require agencies to analyze options for
regulatory relief of small entities. For
purposes of the RFA, small entities
include small businesses, certain
nonprofit organizations, and small
governmental jurisdictions. Individuals
and States are not included in the
definition of a small entity. The RFA, as
amended, requires an agency to prepare
and make available to the public a
regulatory flexibility analysis that
describes the effect of a proposed rule
on small entities when the agency is
required to publish a general notice of
proposed rulemaking for any proposed
rule. Because this rule is being issued as
an interim final rule, on the grounds set
forth above, a regulatory flexibility
analysis is not required under the RFA.
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 rule under the
threshold criteria of Executive Order
13132, we have determined that this
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.
The Office of Management and Budget
(OMB) has reviewed this rule in
accordance with Executive Order 12866.
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
E:\FR\FM\26MRR1.SGM
26MRR1
Federal Register / Vol. 73, No. 59 / Wednesday, March 26, 2008 / Rules and Regulations
final OMB approval, on any information
collection requirements set forth in
rulemaking.
This rule will not impose any
information collection burden or affect
information currently collected by OIG.
IV. Inspection of Public Comments
All comments received before the end
of the comment period are available for
viewing by the public. All comments
will be posted on https://
www.regulations.gov as soon as possible
after they have been received.
Comments received timely will also be
available for public inspection as they
are received at Office of Inspector
General, Department of Health and
Human Services, Cohen Building, 330
Independence Avenue, SW.,
Washington, DC 20201, Monday
through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an
appointment to view public comments,
phone (202) 619–0089.
List of Subjects in 42 CFR Part 1008
Administrative practice and
procedure, Fraud, Grant programs—
health, Health facilities, Health
professions, Medicaid, Medicare,
Penalties.
I Accordingly, 42 CFR chapter V,
subchapter B is mended as set forth
below:
PART 1008—[AMENDED]
1. The authority citation for part 1008
continues to read as follows:
I
Authority: 42 U.S.C. 1320a–7d(b)
2. Section 1008.31 is amended by
revising paragraph (b) to read as follows:
I
§ 1008.31 OIG fees for the cost of advisory
opinions.
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*
*
*
*
(b) Payment Method. Payment for a
request for an advisory opinion must be
made to the Treasury of the United
States, as directed by OIG.
*
*
*
*
*
I 3. Section 1008.36 is amended by
removing paragraph (b)(6) and
redesignating paragraphs (b)(7) and
(b)(8) as (b)(6) and (b)(7) respectively.
*
*
*
*
*
I 4. Section 1008.43 is amended by
revising paragraph (d) to read as
follows:
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§ 1008.43
opinion.
Issuance of a formal advisory
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(d) After OIG has notified the
requestor of the full amount owed and
OIG has determined that the full
payment of that amount has been
VerDate Aug<31>2005
16:40 Mar 25, 2008
Jkt 214001
properly paid by the requestor, OIG will
issue the advisory opinion and
promptly mail it to the requestor by
regular first class U.S. mail.
Dated: January 30, 2008.
Daniel R. Levinson,
Inspector General.
Approved: February 28, 2008.
Michael O. Leavitt, Secretary.
[FR Doc. E8–6164 Filed 3–25–08; 8:45 am]
BILLING CODE 4152–01–P
OFFICE OF MANAGEMENT AND
BUDGET
Office of Federal Procurement Policy
48 CFR Part 9903
Cost Accounting Standards Board;
Contract Clauses
Cost Accounting Standards
Board, Office of Federal Procurement
Policy, OMB.
ACTION: Final rule.
AGENCY:
SUMMARY: The Cost Accounting
Standards (CAS) Board has adopted,
without change, a final rule to add a
clause for inclusion in CAS-covered
contracts and subcontracts awarded to
foreign concerns. The Board is taking
this action to provide a standard clause
for use by Government and contractor
personnel in applying the CAS
requirements to contracts and
subcontracts awarded to foreign
concerns.
DATES: Effective Date: April 25, 2008.
FOR FURTHER INFORMATION CONTACT:
Laura Auletta, Manager, Cost
Accounting Standards Board, 725 17th
Street, NW., Room 9013, Washington,
DC 20503 (telephone: 202–395–3256).
Reference CAS–2007–01F.
SUPPLEMENTARY INFORMATION:
A. Background
The CAS Board published a proposed
rule on June 14, 2007 (72 FR 32829) to
provide a clause for use in contracts
with foreign concerns. Prior to
November 4, 1993, modified CAS
coverage required a contractor to
comply with only CAS 401 and CAS
402. Similarly, 9903.201–1(b)(4)
required that foreign concerns comply
with only CAS 401 and 402. Thus, prior
to November 4, 1993, the contract clause
at 9903.201–4(c) was used for both
contracts with modified coverage and
contracts with foreign concerns.
However, on November 4, 1993, the
Board revised the definition of modified
coverage to include CAS 405 and 406,
so that modified coverage currently
PO 00000
Frm 00079
Fmt 4700
Sfmt 4700
15939
includes CAS 401, 402, 405, and 406
(see 9903.201–2(b)). In conjunction with
the revised definition of modified
coverage, the Board also amended the
clause at 9903.201–4(c) to include CAS
405 and 406. However, the Board did
not change the requirement that foreign
concerns comply with only CAS 401
and 402. As a result, the contract clause
at 9903.201–4(c) could not be used for
foreign concerns without modification
by the parties.
This final rule provides a clause for
use in contracts with foreign concerns
that will not require modification.
Except that it includes only CAS 401
and 402, this clause is identical to the
clause currently applicable to contracts
subject to modified coverage. To effect
this change, this final rule amends
9903.201–4, Contract Clauses, to
include the new clause at (f), Disclosure
and Consistency of Cost Accounting
Practices—Foreign Concerns.
The Board received no public
comments in response to the proposed
rule and has adopted the proposed rule
as a final rule without change.
B. Paperwork Reduction Act
The Paperwork Reduction Act, Public
Law 96–511, does not apply to this
rulemaking, because this rule imposes
no paperwork burden on offerors,
affected contractors and subcontractors,
or members of the public which requires
the approval of OMB under 44 U.S.C.
3501, et seq.
C. Regulatory Flexibility Act, Unfunded
Mandates Reform Act, Congressional
Review Act, and Executive Orders
12866 and 13132
The Board certifies that this rule will
not have a significant effect on a
substantial number of small entities
within the meaning of the Regulatory
Flexibility Act, 5 U.S.C. 601, et seq.,
because small businesses are exempt
from the application of the Cost
Accounting Standards. For purposes of
the Unfunded Mandates Reform Act of
1995, as well as Executive Orders 12866
and 13132, the final rule will not
significantly or uniquely affect small
governments, does not have federalism
implications, and will not result in
increased expenditures by State, local,
and tribal governments, or by the
private sector, of $100 million or more.
In addition, the Board has determined
that this rule is not economically
significant under the provisions of
Executive Order 12866 or otherwise
subject to Executive Order 12866
review. Finally, the final rule is not a
‘‘major rule’’ under 5 U.S.C. Chapter 8;
the rule will not have any of the effects
set forth in 5 U.S.C. 804(2).
E:\FR\FM\26MRR1.SGM
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]]>Agencies
[Federal Register Volume 73, Number 59 (Wednesday, March 26, 2008)]
[Rules and Regulations]
[Pages 15937-15939]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-6164]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Office of Inspector General
42 CFR Part 1008
Medicare and State Health Care Programs: Fraud and Abuse;
Issuance of Advisory Opinions by 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 amends the
OIG regulations at 42 CFR part 1008 by (1) revising the process for
advisory opinion requestors to submit payments for advisory opinion
costs, and (2) clarifying that notices to the public announcing
procedures for processing advisory opinion requests will be published
on OIG's Web site.
DATES: Effective Date: These regulations are effective on April 25,
2008.
Comment Period: To assure consideration, public comments must be
delivered to the address provided below by no later than 5 p.m. on
April 25, 2008.
ADDRESSES: In commenting, please refer to file code OIG-223-IFC.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of three ways (no duplicates,
please):
1. Electronically. You may submit electronic comments on specific
recommendations and proposals through the Federal eRulemaking Portal at
https://www.regulations.gov. (Attachments should be in Microsoft Word,
if possible.)
2. By regular, express, or overnight mail. You may send written
comments to the following address: Office of Inspector General,
Department of Health and Human Services, Attention: OIG-223-IFC, Room
5246, Cohen Building, 330 Independence Avenue, SW., Washington, DC
20201. Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By hand or courier. If you prefer, you may deliver, by hand or
courier, your written comments before the close period to Office of
Inspector General, Department of Health and Human Services, Cohen
Building, 330 Independence Avenue, SW., Washington, DC 20201. Because
access to the interior of the Cohen Building is not readily available
to persons without Federal Government identification, commenters are
encouraged to schedule their delivery with one of our staff members at
(202) 358-3141.
For information on viewing public comments, please see section IV
in the Supplementary information section below.
FOR FURTHER INFORMATION CONTACT: Meredith Melmed, Office of Counsel to
the Inspector General, (202) 619-0335.
SUPPLEMENTARY INFORMATION:
I. Background
A. Section 205 of Public Law 104-191
The Health Insurance Portability and Accountability Act of 1996
(HIPAA), Public Law 104-101, 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 Department of Justice, 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.
---------------------------------------------------------------------------
\1\ Public 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.
---------------------------------------------------------------------------
B. OIG Final Regulations
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. Provisions of the Interim Final Rule
By statute, the Department must charge a fee equal to the costs
incurred by the Department in responding to a request for an advisory
opinion. (42 U.S.C. 1320a-7d(b)(5)(B)(ii)). Under the interim final and
final advisory opinion rules, we directed requestors to make an initial
payment to the U.S. Treasury by check or money order in the amount of
$250. The regulations have also allowed for the acceptance of final
payment of the fee by check or money order.
Through this interim final rule, we are setting forth several
revisions to the payment process for advisory opinion requests.
Specifically, we are modifying our procedures for submitting an
advisory opinion request by deleting the current requirements at
Sec. Sec. 1008.31(b) and 1008.36(b)(6) for an initial payment of $250
for each advisory opinion request, and replacing the existing provision
set forth in Sec. 1008.31(b) with a requirement that payment for an
advisory opinion be made directly to the Treasury of the United States,
as directed by OIG. In addition, we are amending 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.
[[Page 15938]]
A. Electronic Payment Directly to the U.S. Treasury
As of the effective date of this rule, we will no longer accept
checks or money orders from requesting parties and will require
payments to be made directly to the United States Treasury through wire
or other electronic funds transfer. Changing the requirement that
payment be made by check or money order to provide for wire or other
electronic funds transfers will create efficiencies in processing
payments for advisory opinion requests, reduce the use of staff
resources to process such payments, and reduce the burden on requesting
parties.
B. Elimination of Initial Deposit
We are also eliminating the initial deposit payment from the
requirements for submitting an advisory opinion request. A deposit is
not required by statute. We believe that deleting the initial deposit
payment will further streamline the electronic payment process and will
eliminate administrative burdens that may arise if an initial deposit
must be returned. For instance, where parties erroneously submit
requests that are wholly outside our authority to issue an advisory
opinion, such as requests regarding issues arising under the physician
self-referral law (42 U.S.C. 1395nn), returning funds submitted
directly to the Department of Treasury would be cumbersome. In
addition, eliminating the initial deposit requirement will reduce the
burden on requesting parties by consolidating the parties' payment
obligations into one final payment. We will provide additional
instructions to the public on our Web site (https://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
OIG has determined that the public notice and comment requirements
of the Administrative Procedure Act, 5 U.S.C. 553(b), do not apply to
this rule because the rule is procedural in nature and does not alter
the substantive rights of the affected parties. Therefore, this rule
satisfies the exemption from notice and comment rulemaking in 5 U.S.C.
553(b)(A). OIG nevertheless invites comments on this rule and will
consider all timely submitted comments.
The advisory opinion process is an established OIG program. This
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
rule will further the public's interest in minimal burden by deleting
the requirement for an initial payment of a deposit to be credited
toward the final advisory opinion processing costs and by allowing the
use of electronic transfers of funds. The 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 rule as required by Executive
Order 12866, the Unfunded Mandates Reform Act of 1995, the Regulatory
Flexibility Act (RFA) of 1980, and Executive Order 13132.
Executive Order 12866
Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, if regulations are
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health, and safety
effects; distributive impacts; and equity). A regulatory impact
analysis must be prepared for major rules with economically significant
effects (i.e., $100 million or more in any given year).
This is not a major rule, as defined at 5 U.S.C. 804(2), and it is
not economically significant since the overall economic effect of the
rule is less than $100 million annually. As indicated in Section II of
this preamble, this rule deals exclusively with the procedural issues
involved in the payment for advisory opinions issued by OIG. This rule
does not address the substance of the anti-kickback statute or other
sanction statutes. This rule does not change any costs associated with
requesting an advisory opinion, but, rather, clarifies the procedures
for submitting statutorily-mandated payment for costs incurred
preparing an advisory opinion. We believe that the aggregate economic
impact of this rule will be minimal and will have no effect on the
economy or on Federal or State expenditures. To the extent that there
is any economic impact, that impact will likely result in savings of
Federal dollars through the improved efficiencies in the use of staff
resources for processing advisory opinion requests and payments related
to advisory opinion requests, as well as savings for parties that
request advisory opinions.
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 $110 million. Since the rule merely revises the
process for paying for advisory opinions and creates greater
efficiencies in processing payments, we believe that this rule that
will not impose any mandates on State, local, or tribal governments or
the private sector that would result in an expenditure of $110 million
or more (adjusted for inflation) in any given year, and that a full
analysis under the Unfunded Mandates Reform Act is not necessary.
Regulatory Flexibility Act
The RFA and the Small Business Regulatory Enforcement and Fairness
Act of 1996, which amended the RFA, require agencies to analyze options
for regulatory relief of small entities. For purposes of the RFA, small
entities include small businesses, certain nonprofit organizations, and
small governmental jurisdictions. Individuals and States are not
included in the definition of a small entity. The RFA, as amended,
requires an agency to prepare and make available to the public a
regulatory flexibility analysis that describes the effect of a proposed
rule on small entities when the agency is required to publish a general
notice of proposed rulemaking for any proposed rule. Because this rule
is being issued as an interim final rule, on the grounds set forth
above, a regulatory flexibility analysis is not required under the RFA.
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 rule under the threshold criteria of
Executive Order 13132, we have determined that this 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.
The Office of Management and Budget (OMB) has reviewed this rule in
accordance with Executive Order 12866.
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
[[Page 15939]]
final OMB approval, on any information collection requirements set
forth in rulemaking.
This rule will not impose any information collection burden or
affect information currently collected by OIG.
IV. Inspection of Public Comments
All comments received before the end of the comment period are
available for viewing by the public. All comments will be posted on
https://www.regulations.gov as soon as possible after they have been
received. Comments received timely will also be available for public
inspection as they are received at Office of Inspector General,
Department of Health and Human Services, Cohen Building, 330
Independence Avenue, SW., Washington, DC 20201, Monday through Friday
of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to
view public comments, phone (202) 619-0089.
List of Subjects in 42 CFR Part 1008
Administrative practice and procedure, Fraud, Grant programs--
health, Health facilities, Health professions, Medicaid, Medicare,
Penalties.
0
Accordingly, 42 CFR chapter V, subchapter B is mended as set forth
below:
PART 1008--[AMENDED]
0
1. The authority citation for part 1008 continues to read as follows:
Authority: 42 U.S.C. 1320a-7d(b)
0
2. Section 1008.31 is amended by revising paragraph (b) to read as
follows:
Sec. 1008.31 OIG fees for the cost of advisory opinions.
* * * * *
(b) Payment Method. Payment for a request for an advisory opinion
must be made to the Treasury of the United States, as directed by OIG.
* * * * *
0
3. Section 1008.36 is amended by removing paragraph (b)(6) and
redesignating paragraphs (b)(7) and (b)(8) as (b)(6) and (b)(7)
respectively.
* * * * *
0
4. Section 1008.43 is amended by revising paragraph (d) to read as
follows:
Sec. 1008.43 Issuance of a formal advisory opinion.
* * * * *
(d) After OIG has notified the requestor of the full amount owed
and OIG has determined that the full payment of that amount has been
properly paid by the requestor, OIG will issue the advisory opinion and
promptly mail it to the requestor by regular first class U.S. mail.
Dated: January 30, 2008.
Daniel R. Levinson,
Inspector General.
Approved: February 28, 2008.
Michael O. Leavitt, Secretary.
[FR Doc. E8-6164 Filed 3-25-08; 8:45 am]
BILLING CODE 4152-01-P
