Agency Information Collection Activities: Proposed Collection; Comment Request

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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