[Federal Register Volume 62, Number 55 (Friday, March 21, 1997)]
[Notices]
[Pages 13621-13622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7138]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary
[Document Identifier: OIG-10-ICF]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Office of Inspector General (OIG), HHS.

ACTION: Notice.

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SUMMARY: The proposed information collection requirement described 
below will be submitted to the Office of Management and Budget for 
review, as required by the Paperwork Reduction Act. The Department is 
soliciting public comment on the proposed application of preliminary 
questions under the Office of Inspector General's (OIG) advisory 
opinion process in accordance with section 205 of the Health Insurance 
Portability and Accountability Act of 1996.

DATES: Written comments should be received by May 20, 1997.

ADDRESSES: Interested persons are invited to submit comments regarding 
this collection of information. Comments should refer to the document 
identifier code OIG-10-IFC, and should be sent to: Cynthia Agens Bauer, 
OS Reports Clearance Officer, Room 503H, Humphrey Building, 200 
Independence Avenue, S.W., Washington, D.C. 20201.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
project or to obtain a copy of the information collection plans and 
instruments, please contact the OS Reports Clearance Officer, (202) 
690-6207.

SUPPLEMENTARY INFORMATION: The Department of Health and Human Services, 
Office of the Secretary periodically publishes summaries of proposed 
information collection projects and solicits public comments in 
compliance with the requirements of section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995. Interested persons are invited to send 
comments regarding burden estimates or any aspect of the collection of 
information, including (1) whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information will have practical 
utility; (2) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (3) ways to enhance the quality, 
utility and clarity of the information to be collected; and (4) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology.
    Type of information collection request: OIG Advisory Opinion 
Procedures in 42
    CFR Part 1008 and Preliminary Questions. Section 205 of the Health 
Insurance Portability and Accountability Act of 1996, Public Law 104-
191, requires the Department to provide advisory opinions to the public 
regarding several categories of subject matter, including the 
requestor's potential liability under sections 1128, 1128A and 1128B of 
the Social Security Act (the Act). The Office of Inspector General 
(OIG) has separately published interim final regulations in the Federal 
Register on February 19, 1997 (62 FR 7350) setting forth the procedures 
under which members of the public may request advisory opinions from 
the OIG. That discussion contains a more thorough discussion of the 
advisory opinion process and the role of these preliminary questions. 
In order to aid potential requestors and the OIG in providing opinions 
under this process, the OIG is providing preliminary questions that may 
be answered in an advisory opinion request. These preliminary questions 
will be voluntary and will correspond with each sanction provision 
about which advisory opinions will be rendered. The aggregate 
information burden for the information collection requirements 
contained in the interim final rule, in conjunction with the 
preliminary questions, is set forth below.
    Respondents: The ``respondents'' for the collection of information 
described in the OIG rulemaking will be self-selected individuals and 
entities that choose to submit request for advisory opinions to the 
OIG. We anticipate that the respondents will include many types of 
health care providers, from sole practitioner physicians to large 
diversified publicly-traded corporations.
    Estimated number of respondents: 500. Most individuals and entities 
that provide medical services that may be paid for by Medicare, 
Medicaid or Federal health care programs could potentially have 
questions regarding one of the subject matters about which the OIG will 
issue advisory opinions. In reality, we believe that the number of 
requestors will be a small fraction of such providers.
    Over the past several years, the Office of the General Counsel, 
Inspector General Division has answered telephone inquiries from 
individuals and entities seeking informal guidance with respect to the 
Medicare and State health care programs' anti-kickback statute and 
other sanction authorities. Many of the inquiries related to 
authorities outside the scope of the advisory opinion process, such as 
the self-referral provisions of section 1877 of the Act. In addition, 
we believe that most of the inquiries received have been of a nature 
that the caller or requestor would be unlikely to request a formal 
written advisory opinion on the subject matter. Many inquiries related 
to rather simple and straight-forward matters that could have been 
researched by private counsel at relatively minor expense. 
Nevertheless, the rate of these telephone inquiries form a starting 
point for estimating point for estimating the potential number of 
advisory opinion requests.
    We estimate that the OIG received an average of six related 
telephone inquiries per day over the past several years. Using that 
history as a general guide and benchmark, we estimate an annual number 
of 500 respondents. Obviously, the actual number of requests could be 
larger since, for the first time, formal written opinions are 
available. Conversely, the number of inquiries could be less based on 
combination of several unquantifiable reasons, including the desire not 
to have one's arrangement be subject to scrutiny by the OIG (following 
issuance of the opinion) and the general public.
    Estimated number of responses per respondent: One.
    Estimated total annual (hour) burden on respondents: 5,000 hours. 
We believe that the burden of preparing requests for advisory opinions 
will vary widely depending upon the differences in the size of the 
entity making the request and the complexity of the advice sought. We 
estimate that the average burden for each submitted request for an 
advisory opinion will be in the range of 2 to 40 hours. We further 
believe that the burden for most requests will be closer to the lower 
end of this range, with an average burden of approximately 10 hours per 
respondent.
    The OIG is requiring requests for advisory opinions to involve 
actual or intended fact scenarios. We anticipate that most requests 
will involve business arrangements into which the requesting party 
intends to enter. Because the facts will relate to business plans, the 
requesting party will have collected and analyzed all, or almost all, 
of the information we will need to collect to review the request. 
Therefore, in order to request an advisory opinion, in many instances 
the requestor will simply have need to compile already collected 
information for our examination. In some cases, the requestor may need 
to

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expend a more significant amount of time and cost in preparing a 
submission related to more complex arrangements that involve a large 
number of parties or participants.
    Estimated annual cost burden on respondents (in addition to the 
hour burden): $1,000,000. In addition to the hour burden on respondents 
discussed above, some respondents may incur additional information 
collection costs related to the purchase of outside professional 
services, such as attorneys or consultants. We believe that the cost 
burden related to such outside assistance will vary from zero to 40 
hours per request, with an average of 10 hours. At the rate of $200 per 
hour, this total burden would amount to $1,000,000.

    Authority: Section 3506 of the Paperwork Reduction Act of 1995, 
44 U.S.C. Chapter 35, as amended.

    Dated: March 10, 1997.
Dennis P. Williams,
Deputy Assistant Secretary, Budget.
[FR Doc. 97-7138 Filed 3-20-97; 8:45 am]
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