[Federal Register Volume 73, Number 59 (Wednesday, March 26, 2008)]
[Rules and Regulations]
[Pages 15937-15939]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-6164]
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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.
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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
http://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.
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\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.
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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 (http://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
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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
http://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]
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