[Federal Register Volume 83, Number 166 (Monday, August 27, 2018)]
[Proposed Rules]
[Pages 43607-43611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18519]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of Inspector General

42 CFR Parts 1001 and 1003

RIN 0936-AA10


Medicare and State Health Care Programs: Fraud and Abuse; Request 
for Information Regarding the Anti-Kickback Statute and Beneficiary 
Inducements CMP

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

ACTION: Request for information.

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SUMMARY: This request for information seeks input from the public on 
how to address any regulatory provisions that may act as barriers to 
coordinated care or value-based care.

DATES: Comment Date: To ensure consideration, comments must be received 
at one of the addresses provided below, no later than 5 p.m. on October 
26, 2018.

ADDRESSES: In commenting, refer to file code OIG-0803-N. Because of 
staff and resource limitations, we cannot accept comments by facsimile 
(fax) transmission. However, you may submit comments in one of three 
ways (no duplicates, please):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular, express, or overnight mail. You may send written 
comments to the following address: Susan Edwards, Office of Inspector 
General, Department of Health and Human Services, Attention: OIG-0803-
N, Room 5513, 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 your written 
comments by hand or courier before the close of the comment period to: 
Susan Edwards, Office of Inspector General, Department of Health and 
Human Services, Attention: OIG-0803-N, Room 5513, 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) 619-0335.

[[Page 43608]]

    For information on viewing public comments, please see the 
SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Susan Edwards, (202) 708-9845.

SUPPLEMENTARY INFORMATION:
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following 
website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to 
view public comments. Comments received in a timely manner will also be 
available for public inspection as they are received at the Office of 
Inspector General, Department of Health and Human Services, Cohen 
Building, 330 Independence Avenue SW, Washington, DC 20201, Monday 
through Friday, from 10 a.m. to 5 p.m. To schedule an appointment to 
view public comments, phone (202) 619-0335.

I. Introduction

    The Department of Health and Human Services (HHS) is working to 
transform the health care system into one that better pays for value. 
Care coordination is a key aspect of systems that deliver value. 
Removing unnecessary government obstacles to care coordination is a key 
priority for HHS. To help accelerate the transformation to a value-
based system that includes care coordination, HHS has launched a 
Regulatory Sprint to Coordinated Care, led by the Deputy Secretary. 
This ``Regulatory Sprint'' is focused on identifying regulatory 
provisions that may act as barriers to coordinated care, assessing 
whether those regulatory provisions are unnecessary obstacles to 
coordinated care, and issuing guidance or revising regulations to 
address such obstacles and, as appropriate, to encourage and 
incentivize coordinated care while protecting against harms caused by 
fraud and abuse.
    The Office of Inspector General (OIG) seeks to identify ways in 
which it might modify or add new safe harbors to the anti-kickback 
statute and exceptions to the beneficiary inducements civil monetary 
penalty (CMP) definition of ``remuneration'' in order to foster 
arrangements that would promote care coordination and advance the 
delivery of value-based care, while also protecting against harms 
caused by fraud and abuse. Through internal discussion and with the 
benefit of facts and information received from external stakeholders, 
OIG has identified the broad reach of the anti-kickback statute and 
beneficiary inducements CMP as a potential impediment to beneficial 
arrangements that would advance coordinated care. To inform our 
efforts, we welcome public comment on the safe harbors to the anti-
kickback statute and the exceptions to the beneficiary inducements CMP 
definition of ``remuneration'' as they relate to the goals of the 
Regulatory Sprint outlined above. In particular, we welcome comments in 
response to the questions presented in this Request for Information 
(RFI).

II. Background

    Section 1128B(b) of the Social Security Act (the Act), the Federal 
anti-kickback statute, provides criminal penalties for individuals or 
entities that knowingly and willfully offer, pay, solicit, or receive 
remuneration to induce or reward the referral of business reimbursable 
under Federal health care programs, as defined in section 1128B(f) of 
the Act. The law endeavors to protect patients and the Federal health 
care programs from fraud and abuse by curtailing the corrupting 
influence of remuneration on health care decisions; however, because 
the statute is broadly written, when it was enacted there was concern 
that some relatively innocuous and potentially beneficial arrangements 
were technically covered by the statute and therefore were subject to 
criminal prosecution.
    In response to this concern, Congress passed section 14 of the 
Medicare and Medicaid Patient and Program Protection Act of 1987, which 
required HHS to set forth ``safe harbors'' to the anti-kickback 
statute. Specifically, section 1128B(b)(3)(E) of the Act protects from 
the anti-kickback statute ``any payment practice specified by the 
Secretary in regulations promulgated pursuant to section 14(a) of the 
Medicare and Medicaid Patient and Program Protection Act of 1987.'' In 
giving HHS the authority to protect certain arrangements and payment 
practices under the anti-kickback statute, Congress intended the safe 
harbors to be evolving rules that would be updated periodically to 
reflect changing business practices and technologies in the health care 
industry.\1\
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    \1\ H.R. Rep. No. 100-85, Pt. 2, at 27 (1987).
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    Health care providers and others may voluntarily comply with safe 
harbors in an effort to ensure that their business practices will not 
be subject to criminal prosecution under the anti-kickback statute, the 
imposition of civil monetary penalties (CMPs) under section 1128A(a)(7) 
of the Act, program exclusion under section 1128(b)(7) of the Act, and 
liability under the False Claims Act (31 U.S.C. 3729-33). Since 
finalizing the first safe harbors in 1991, OIG has continued to engage 
the industry on the application of the Federal anti-kickback statute 
and development of safe harbors.
    Section 1128A(a)(5) of the Act, the beneficiary inducements CMP, 
provides for the imposition of CMPs against any person who offers or 
transfers remuneration to a Medicare or State health care program 
beneficiary that the benefactor knows or should know is likely to 
influence the beneficiary's selection of a particular provider, 
practitioner, or supplier of any item or service for which payment may 
be made, in whole or in part, by Medicare or a State health care 
program. In the same administrative proceedings in which it may seek to 
impose CMPs against a person, OIG may seek to exclude such person from 
the Federal health care programs. For purposes of section 1128A(a)(5) 
of the Act, the statute defines ``remuneration'' to include, without 
limitation, waivers of co-payments and deductible amounts (or any part 
thereof) and transfers of items or services for free or for other than 
fair market value.\2\ The statute and associated regulations contain a 
limited number of exceptions.\3\
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    \2\ See section 1128A(i)(6) of the Act.
    \3\ See id.; 42 CFR 1003.110.
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    OIG is mindful of the impact of delivery system and payment reform 
on Federal health care programs and the changing relationships between 
providers, suppliers, and other entities in delivering higher quality, 
better coordinated care; enhancing value; and improving the overall 
health of patients. We have received several suggestions for new safe 
harbors and proposed modifications to existing safe harbors that may 
promote care coordination and reduce regulatory impediments to value-
based arrangements, including in response to our annual ``Solicitation 
of New Safe Harbors and Special Fraud Alerts.'' \4\
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    \4\ See, e.g., Solicitation of New Safe Harbors and Special 
Fraud Alerts, 82 FR 61,229 (Dec. 27, 2017), available at https://www.gpo.gov/fdsys/pkg/FR-2017-12-27/pdf/2017-27117.pdf; OIG, 
Semiannual Report to Congress, April 1, 2017-September 30, 2017, 
available at https://oig.hhs.gov/reports-and-publications/archives/semiannual/2017/sar-fall-2017.pdf.
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    We continue to consider how to balance additional flexibility for 
industry stakeholders to provide

[[Page 43609]]

efficient, well-coordinated, patient-centered care with protections 
against the harms caused by fraud and abuse. We are requesting 
additional information in this RFI to help inform our efforts. We are 
particularly interested in thoughts on topics that include, but are not 
limited to: (i) The structure of arrangements between parties that 
participate in alternative payment models or other novel financial 
arrangements designed to promote care coordination and value; (ii) the 
need for new or revised safe harbors and exceptions to the definition 
of ``remuneration'' under the beneficiary inducements CMP to promote 
beneficial care coordination, patient engagement, and value-based 
arrangements; and (iii) terminology related to alternative payment 
models, value-based arrangements, and care coordination. We are 
interested in any special considerations for rural providers and others 
serving underserved populations, including American Indian and Alaska 
Native communities.
    Where relevant, we intend to review comments submitted in response 
to the Medicare Program; Request for Information Regarding the 
Physician Self-Referral Law, RIN 0938-AT64, issued by the Centers for 
Medicare & Medicaid Services (CMS).\5\ However, given the volume of 
questions included in that RFI and OIG's separate, and different, 
authorities, we urge individuals and entities to resubmit any relevant 
comments to this RFI to ensure they are considered by OIG. We look 
forward to receiving input in response to this RFI.
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    \5\ Medicare Program; Request for Information Regarding the 
Physician Self-Referral Law, 83 FR 29,524 (June 25, 2018), available 
at https://www.gpo.gov/fdsys/pkg/FR-2018-06-25/pdf/2018-13529.pdf.
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III. Request for Information

    We welcome public input on any or all of the topics identified 
below. Respondents are not required to address every issue or respond 
to every question discussed in this RFI to have their responses 
considered.

1. Promoting Care Coordination and Value-Based Care

    A. Please tell us about potential arrangements that the industry is 
interested in pursuing, such as care coordination, value-based 
arrangements, alternative payment models, arrangements involving 
innovative technology, and other novel financial arrangements that may 
implicate the anti-kickback statute or beneficiary inducements CMP. For 
example, we are interested in better understanding the structure and 
terms of the arrangement (e.g., categories/types of parties; how risk 
is allocated among parties; financial relationships involving potential 
referral sources and seekers created by the arrangement; and types of 
items and services provided by the arrangement). We are also interested 
in understanding how the arrangement promotes care coordination or 
value-based care and how the arrangement prevents potential harms, such 
as increased costs, inappropriate utilization, poor quality of care, 
and distorted decision making.
    B. Please identify what, if any, additional or modified safe 
harbors to the anti-kickback statute or exceptions to the definition of 
``remuneration'' under the beneficiary inducements CMP may be necessary 
to protect such arrangements and any key provisions that should be 
included in the additional or modified safe harbor or exception. 
Existing safe harbors and exceptions of particular relevance to 
coordinated care include, for example, those related to personal 
services and management contracts, electronic health record 
arrangements, warranties, transportation, and promoting access to care. 
Suggested new safe harbors or exceptions might address care 
coordination services arrangements or arrangements promoting the use of 
innovative technology. In particular, please describe what conditions 
would be appropriate to include in a safe harbor or exception to 
protect against fraud and abuse in the context of such arrangements, 
including what, if any, disclosures should be required by such safe 
harbors or exceptions.
    C. Please explain how ``value'' could be defined and used in a safe 
harbor or exception such that OIG could evaluate ``value'' within an 
arrangement to determine compliance with the safe harbor or exception.
    D. In the context of health care delivery reform, payment reform, 
and the anti-kickback statute, please share thoughts on definitions for 
critical terminology such as:

i. Alternative payment model
ii. Care coordination services
iii. Care coordinator
iv. Clinical integration
v. Coordinated care
vi. Financial integration
vii. Gainsharing
viii. Health system
ix. Integrated care model
x. Integrated delivery system
xi. Incentive payments
xii. Outcomes-based care
xiii. Risk
xiv. Risk-sharing
xv. Value-based care
xvi. Value-based arrangement

    E. Are there opportunities where OIG could clarify its position 
through guidance as opposed to regulation? For example, would a law 
enforcement policy statement offer sufficient protection in some 
instances? If so, please elaborate.

2. Beneficiary Engagement

A. Beneficiary Incentives
    i. Please provide feedback regarding the types of incentives 
providers, suppliers, and others are interested in providing to 
beneficiaries, how providing such incentives would contribute to or 
improve quality of care, care coordination, and patient engagement, 
including adherence to care plans, and whether the types of providers, 
suppliers, or other entities that furnish the incentives matter from an 
effectiveness and program integrity perspective. Please be as specific 
as possible. Additional areas of interest include:
    a. What, if any, restrictions should OIG place on the sources, 
types, or frequency of beneficiary incentives that could be provided to 
reduce the risk of fraud and abuse?
    b. Examples of beneficiary incentive arrangements that are 
appropriate and effective.
    c. Should beneficiary incentives connected to medication adherence 
and medication management be treated differently than other types of 
beneficiary incentives? If so, how and why?
    d. What, if any, disclosures should OIG require the offeror to make 
to beneficiaries regarding an incentive (e.g., the source of the 
incentive)?
    ii. Please identify (and provide citations to) any recent studies 
assessing the positive or negative effects of beneficiary incentives on 
patient care or patient engagement.
    iii. In the context of beneficiary incentives, please identify any 
risks or benefits from the following types of potential remuneration, 
as well as any safeguards to mitigate risks, and describe how these 
terms should be defined for purposes of any rulemaking related to 
coordinated care or value-based arrangements:

a. Cash equivalent
b. Gift card
c. In-kind items and services
d. Nonmonetary remuneration

    iv. To promote care coordination and value-based care, should OIG 
amend its ``Office of Inspector General Policy Statement Regarding 
Gifts of Nominal Value To Medicare and Medicaid

[[Page 43610]]

Beneficiaries'' \6\ to increase ``nominal value'' from no more than $15 
per item or $75 in the aggregate per patient on an annual basis? If so, 
why? Please provide data or other support for any suggested changes in 
the dollar amounts. Also, please provide input on whether OIG should 
have a similar policy under the anti-kickback statute and, if so, how 
such policy would contribute to care coordination or value-based care.
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    \6\ OIG, Office of Inspector General Policy Statement Regarding 
Gifts of Nominal Value To Medicare and Medicaid Beneficiaries (Dec. 
7, 2016), available at https://oig.hhs.gov/fraud/docs/alertsandbulletins/OIG-Policy-Statement-Gifts-of-Nominal-Value.pdf.
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B. Cost-Sharing Obligations
    i. We are interested in input about how relieving or eliminating 
beneficiary cost-sharing obligations might improve care delivery, 
enhance value-based arrangements, and promote quality of care. Please 
describe any patient care scenarios in which cost-sharing obligations 
are particularly problematic.
    ii. Please describe the financial impact on providers, suppliers, 
and other entities, as well as the fraud and abuse risks, if cost-
sharing amounts could be waived (i.e., the amount owed is not paid) by 
participants in a care coordination or value-based arrangement. What, 
if any, concerns arise if cost-sharing obligations could be subsidized 
by providers, suppliers, or other entities in a care delivery 
arrangement?
    iii. Please describe any risks to beneficiaries and Federal health 
care programs from the reduction or elimination of cost-sharing 
obligations.
    iv. Please describe any suggested protections or safeguards that 
OIG should incorporate if we were to create a safe harbor for certain 
beneficiary cost-sharing waiver or subsidy arrangements.

3. Other Related Topics of Interest

A. Current Fraud and Abuse Waivers
    i. Please provide feedback on the current waivers developed for the 
purposes of testing models by the Center for Medicare and Medicaid 
Innovation (Innovation Center) and carrying out the Medicare Shared 
Savings Program (MSSP).\7\ Feedback from parties who are using or who 
are eligible to use those waivers would be helpful as we consider the 
issues raised in this RFI. For example, we are interested in the 
following:
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    \7\ CMS, Fraud and Abuse Waivers for Select CMS Models and 
Programs, available at https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/Fraud-and-Abuse-Waivers.html.
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    a. How, if at all, have stakeholders found compliance with the 
waiver conditions challenging? Please be as specific as possible.
    b. Are any waiver requirements particularly burdensome, such that 
they impede the goals of the models, initiatives, or programs? If so, 
please specify which waiver requirements and why they impede the goals 
of the model, initiative, or program.
    c. What waiver structures or conditions, if any, work well? Should 
OIG consider any waiver structures or conditions for any future safe 
harbors or exceptions related to care coordination and value-based care 
(including beneficiary incentives to promote patient engagement)? 
Please be as specific as possible and provide reasons.
    d. One of the key safeguards to mitigate the risk of fraud or abuse 
from arrangements protected by the pre-participation and participation 
waivers developed pursuant to the MSSP, the Next Generation ACO Model's 
participation waiver, and the Pioneer ACO Model's participation waiver 
\8\ is the involvement of the accountable care organization's (ACO's) 
governing body in the authorization of each arrangement. We are 
interested in feedback on how the ACO governing body concept is 
working, and whether and if so how, it could be applied to safe harbors 
or exceptions for alternative payment models and coordinated care 
arrangements.
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    \8\ The Pioneer ACO model began in 2012, and the final 
performance year concluded on December 31, 2016.
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    e. We invite specific feedback regarding the pros and cons of fraud 
and abuse protections (e.g., waivers or safe harbors) that are uniform 
across different types of CMS-sponsored models, initiatives, and 
programs.

B. Cybersecurity-Related Items and Services

    i. We are aware of interest in donating or subsidizing 
cybersecurity-related items and services to providers and others with 
whom they share information. We are interested in information about the 
types of cybersecurity-related items or services that entities wish to 
donate or subsidize, and how existing fraud and abuse laws may pose 
barriers to such arrangements. For example, we are interested in (i) 
the types of persons that would be parties to, or benefit from, such 
arrangements; (ii) whether any persons should be excluded from such 
arrangements; (iii) the particular types of items that would be 
involved in such arrangements (e.g., hardware, software, and other 
items); and (iv) the types of services that would be involved in such 
arrangements (e.g., testing services, training services, monitoring 
services, or repair or maintenance services). Other areas of interest 
include:
    a. How might such items or services reduce cybersecurity risks to 
the following: The donor, the recipient, patients, and other nonparties 
to the arrangement?
    b. Are there technical or legal barriers (besides the physician 
self-referral law and the anti-kickback statute) that could prevent or 
limit the arrangements?
    c. Are there any potential risks or unintended consequences to such 
arrangements (e.g., potential for fraud or abuse, information blocking, 
or anti-competitive practices) and, if so, how might these risks be 
mitigated?
    d. Are there any particular risks if HHS takes no action?

C. ACO Beneficiary Incentive Program (Section 50341(b) of the 
Bipartisan Budget Act of 2018) \9\
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    \9\ Bipartisan Budget Act of 2018, Public Law 115-123, 115th 
Cong. (2018) (enacted).
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    Section 50341(b) of the Bipartisan Budget Act of 2018, which added 
section 1128B(b)(3)(K) of the Act, states that ``illegal remuneration'' 
under the anti-kickback statute does not include ``. . . an incentive 
payment made to a Medicare fee-for-service beneficiary by an ACO under 
an ACO Beneficiary Incentive Program established under subsection (m) 
of section 1899, if the payment is made in accordance with the 
requirements of such subsection and meets such other conditions as the 
Secretary may establish.''
    i. For the purposes of implementing this new statutory exception 
through a safe harbor, what, if any, ``other conditions'' should this 
safe harbor include as protections or safeguards? Please provide 
supporting reasons.

D. Telehealth (Section 50302(c) of the Bipartisan Budget Act of 2018) 
\10\
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    \10\ Id.
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    Section 50302(c) of the Bipartisan Budget Act of 2018 creates a new 
exception to the definition of ``remuneration'' in the beneficiary 
inducements CMP. This exception applies to ``telehealth technologies'' 
provided on or after January 1, 2019, by a provider of services or a 
renal dialysis facility to an individual with end-stage renal disease 
(ESRD) who is receiving home dialysis for which payment is being made 
under Medicare Part B. Under the statute, ``telehealth technologies'' 
is a term to be defined by the Secretary. The exception requires that 
(i) the telehealth technologies not be offered as part of any 
advertisement

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or solicitation; (ii) the telehealth technologies must be provided for 
the purpose of furnishing telehealth services related to the patient's 
ESRD; and (iii) the provision of the telehealth technologies must 
``meet[[hairsp]] any other requirements set forth in regulations 
promulgated by the Secretary.''
    i. For the purposes of this exception, please provide input on how 
``telehealth technologies'' should be defined. Please provide examples 
of telehealth technologies that may be used to furnish telehealth 
services related to a beneficiary's ESRD (e.g., technologies that 
address services on the Medicare telehealth list). Also, please 
indicate whether telehealth technologies should include services. If 
so, please explain, in detail, what services should be considered 
``telehealth technologies.''
    ii. For the purposes of this exception, should OIG include 
protections or safeguards as ``any other requirements set forth in 
regulations promulgated by the Secretary?'' If so, please explain what 
protections or safeguards and why.

4. Intersection of Physician Self-Referral Law and Anti-Kickback 
Statute

    Please share any feedback regarding specific circumstances in which 
(i) exceptions to the physician self-referral law and safe harbors to 
the anti-kickback statute should align for purposes of the goals of 
this RFI; and (ii) exceptions to the physician self-referral law in 
furtherance of care coordination or value-based care should not have a 
corresponding safe harbor to the anti-kickback statute.
    Respondents are encouraged to provide complete but concise and 
organized responses, including any relevant data and specific examples. 
Respondents are not required to address every issue or respond to every 
question discussed in this RFI to have their responses considered. All 
responses will be considered, provided they contain information OIG can 
use to identify the commenter.
    Please note: This is a request for information only. This RFI is 
issued solely for information and planning purposes; it does not 
constitute a Request for Proposal (RFP), application, proposal 
abstract, or quotation. This RFI does not commit the U.S. Government to 
contract for any supplies or services or make a grant award. Further, 
OIG is not seeking proposals through this RFI and will not accept 
unsolicited proposals. Respondents are advised that the U.S. Government 
will not pay for any information or administrative costs incurred in 
response to this RFI; all costs associated with responding to this RFI 
will be solely at the interested party's expense. Not responding to 
this RFI does not preclude participation in any future procurement, if 
conducted. It is the responsibility of the potential responders to 
monitor this RFI announcement for additional information pertaining to 
this request. Please note that OIG will not respond to questions about 
the policy issues raised in this RFI. Contractor support personnel may 
be used to review RFI responses.
    Responses to this RFI are not offers and cannot be accepted by the 
U.S. Government to form a binding contract or issue a grant. 
Information obtained as a result of this RFI may be used by the U.S. 
Government for program planning on a nonattribution basis. Respondents 
should not include any information that might be considered proprietary 
or confidential. This RFI should not be construed as a commitment or 
authorization to incur costs for which reimbursement would be required 
or sought. All submissions become U.S. Government property and will not 
be returned. OIG may publicly post the comments received or a summary 
thereof.

IV. Collection of Information Requirements

    This document does not impose information collection requirements, 
that is, reporting, recordkeeping, or third-party disclosure 
requirements. However, section III of this document does contain a 
general solicitation of comments in the form of a request for 
information. In accordance with the implementing regulations of the 
Paperwork Reduction Act (PRA), specifically 5 CFR 1320.3(h)(4), this 
general solicitation is exempt from the PRA. Facts or opinions 
submitted in response to general solicitations of comments from the 
public, published in the Federal Register or other publications, 
regardless of the form or format thereof, provided that no person is 
required to supply specific information pertaining to the commenter, 
other than that necessary for self-identification, as a condition of 
the agency's full consideration, are not generally considered 
information subject to the PRA. Consequently, there is no need for 
review by the Office of Management and Budget under the authority of 
the PRA (44 U.S.C. 3501 et seq.).

V. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, if we proceed with a subsequent document, we may respond to the 
comments in the preamble to that document.

    Dated: August 20, 2018.
Daniel R. Levinson,
Inspector General.
[FR Doc. 2018-18519 Filed 8-24-18; 8:45 am]
 BILLING CODE 4152-01-P