Notice2021-20558
OIG Modernization Initiative To Improve Its Publicly Available Resources-Request for Information
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 24, 2021
Issuing agencies
Health and Human Services Department
Abstract
This request for information seeks input from the public on OIG resources and how OIG could enhance the usefulness and timeliness of such resources and improve their accessibility and usability.
Full Text
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<title>Federal Register, Volume 86 Issue 183 (Friday, September 24, 2021)</title>
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[Federal Register Volume 86, Number 183 (Friday, September 24, 2021)]
[Notices]
[Pages 53072-53079]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-20558]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of Inspector General
OIG Modernization Initiative To Improve Its Publicly Available
Resources--Request for Information
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
OIG resources and how OIG could enhance the usefulness and timeliness
of such resources and improve their accessibility and usability.
DATES: Please submit comments electronically at <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the ``Submit a comment'' instructions and
refer to file code OIG-0922-N. Comments must be received no later than
January 31, 2022, to ensure consideration. In light of the broad scope
of the RFI and to provide adequate opportunity for input from a wide
range of stakeholders, we are providing an extended comment period for
this RFI. Thank you in advance for your valued input. For information
on viewing public comments, please see the SUPPLEMENTARY INFORMATION
section.
FOR FURTHER INFORMATION CONTACT: Susan Edwards, (202) 619-0335.
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: <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the search instructions on
that website to view public comments.
I. Introduction
The Department of Health and Human Services (HHS) Office of
Inspector General (OIG) is working to modernize the accessibility and
usability of our publicly available resources, including guidance,
program integrity resources, publicly available data, and advisory
opinions (collectively, resources). Given the significant passage of
time since many of our resources launched and corresponding
advancements in technology, we are looking holistically at where we can
make improvements to delivering publicly available resources
effectively and efficiently. We want to continue producing useful and
timely resources that, among other things, advance the health care
industry's voluntary compliance and help prevent fraud, waste, and
abuse. Further, we are mindful that stakeholders increasingly use new
technologies to ingest, manage, and operationalize data and
information, and we are interested in delivering data and information
in ways that are compatible with the technologies used by stakeholders.
To modernize our publicly available resources, we anticipate a
multistep, multiyear process that prioritizes high-value changes. Input
collected from this RFI will help inform decisions about which areas to
address first. By tailoring our resources in response to stakeholder
[[Page 53073]]
input, and making it easier to use OIG's resources, we hope to spur
improved compliance and innovative approaches within the health care
industry.
Through this Request for Information (RFI), OIG seeks input from
the health care industry and the public, including:
<bullet> Health care providers and suppliers, pharmaceutical and
medical device manufacturers, compliance professionals, attorneys,
boards of directors, payors, health technology companies and
professionals, companies and individuals providing health care-related
services (such as social services or case management), industry
associations, and health care compliance software vendors;
<bullet> State officials who administer or oversee Medicaid and
other State health care programs;
<bullet> Tribal officials and providers and suppliers serving
American Indian and Alaska Native communities;
<bullet> health care consumers and their advocates; and
<bullet> health care researchers and policy analysts.
While our focus is generally on resources related to health care,
we also offer resources related to HHS's human services programs,
including programs administered through grants and contracts, and would
welcome input from stakeholders about resources related to those
programs. Any changes we make will continue to ensure that our content
and information remain 508 compliant.
We want to know whether and how you currently use the OIG resources
listed below, and how we could enhance the value and timeliness of such
resources and improve their accessibility and usability. We also are
interested in input on additional types of OIG resources that would be
useful, or additional subject areas for OIG resources. Specifically, we
seek feedback on:
<bullet> Advisory opinions;
<bullet> fraud alerts (including special fraud alerts);
<bullet> special advisory bulletins;
<bullet> compliance program guidance;
<bullet> frequently asked questions (FAQs), including COVID-19
FAQs;
<bullet> other compliance guidance and resources;
<bullet> corporate integrity agreements (CIAs);
<bullet> the list of excluded individuals/entities (LEIE); and
<bullet> audits and evaluations.
II. RFI Objectives
For 45 years, OIG has provided objective, independent information
to the public to foster an improved understanding of program integrity
risks in HHS programs, enhance compliance practices by industry
stakeholders participating in HHS programs, and protect against fraud
and abuse. OIG issues audit and evaluation reports that contain
findings and recommendations; conducts investigations; and provides
compliance guidance, fraud alerts, and other information to promote
program integrity and compliance. Through this RFI, we seek feedback
from respondents about how they use OIG's resources (and the related
benefits and challenges of such uses) to improve the value and
timeliness of, access to, and the usability of, such resources.
This feedback will inform our efforts to modernize our publicly
available resources. Our goals are to: (i) Continue producing useful
and timely resources, (ii) deliver data and information to the public
using modern technology, and (iii) spur improved compliance and
innovative approaches that adapt to changes in the health care system
and keep pace with technological change.
The health care industry will continue to face many changes. More
specifically, the health care delivery system is undergoing structural
changes resulting from, for example, the COVID-19 public health
emergency; the entrance of new health care stakeholders, such as
digital health technology companies; the development and continuing
proliferation of innovative treatments; and the evolution and
increasing complexity of financial relationships within the health care
industry. Ensuring that OIG's publicly available resources continue to
meet stakeholders' needs as these and other changes unfold is
important. Modernizing OIG's publicly available resources will further
OIG's mission to promote the economy, efficiency, effectiveness, and
integrity of HHS programs, as well as the health and welfare of the
people they serve.
This RFI is an opportunity for a range of stakeholders to suggest
ways to improve the usefulness, timeliness, accessibility, and
usability of OIG's resources by: (i) Providing insights into how they
use OIG resources, (ii) identifying the successes and challenges
organizations have had using OIG resources, and (iii) identifying other
potential opportunities for OIG to provide information to the public
and other stakeholders. We recognize that many of the issues raised by
this RFI may cross different professional disciplines or functions, and
we encourage respondents to incorporate a broad perspective, as
applicable.
Through this RFI, we intend to elicit a more complete and nuanced
understanding of how OIG resources are used by different stakeholders
and how we may best improve upon them and their accessibility. We hope
that respondents provide candid feedback, including examples of
challenges related to any category of OIG resource listed in this RFI,
as well as new opportunities for OIG to provide information and data
more effectively. Feedback that we receive will inform OIG's
consideration and prioritization of potential updates to existing
resources, modifications of processes for developing resources, changes
in how data and information are provided to the public, and development
of new materials or data sets, as appropriate.
Notably, this RFI is just one action we are taking to gather input.
We intend to conduct roundtables and are considering other ways to
collect feedback, such as performing user surveys regarding targeted
aspects of our data. We also are launching a new page on our website to
provide information regarding this initiative.
After reviewing comments submitted in response to this RFI and
feedback received through any other mechanisms, OIG will consider what
changes, if any, should be made to our resources and how to prioritize
and implement those changes. Certain changes to the advisory opinion
process may require amendments to OIG regulations that would be
implemented via notice-and-comment rulemaking. Updated resources, new
materials, or modified processes would be introduced incrementally and
not according to any specific timeline. We anticipate that this
initiative could be a multiyear undertaking. We will prioritize the
highest value actions.
III. Request for Information
Historically, OIG has provided extensive publicly available
resources across a range of compliance and program integrity topics and
information types. For example, some resources provide guidance to the
health care industry related to the Federal anti-kickback statute,\1\
OIG's administrative enforcement authorities, such as the civil
monetary penalty (CMP) provision prohibiting inducements to
beneficiaries (the Beneficiary Inducements CMP),\2\ and other
compliance and program integrity considerations. In addition, the
purpose and goals of OIG's resources vary: Some address trends in the
health care industry that pose a fraud and abuse risk (e.g., fraud
alerts), others
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provide information to encourage compliance best practices (e.g.,
compliance program guidance documents (CPGs) and compliance-focused
toolkits), and others are intended to explain OIG's legal
interpretations of the Federal anti-kickback statute and the agency's
administrative enforcement authorities or to describe our enforcement
priorities (e.g., policy statements). Some resources, such as the LEIE,
provide data that industry stakeholders use for their own operations or
compliance programs. Other resources, such as audit and evaluation
reports, provide both findings and recommendations specific to a
Federal agency, grantee, health care provider, or other entity,
alongside broader takeaways that other stakeholders may use to improve
their own operations.
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\1\ Section 1128B(b) of the Social Security Act (the Act).
\2\ Section 1128A(a)(5) of the Act.
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We recognize that the variety of purposes and goals of OIG's
resources mean that stakeholders access and use this information in a
variety of ways. Respondents interested in providing information
broadly across the categories should read the general questions in
section III.A. Those questions solicit information on OIG's general
approach for providing publicly available resources and issues that may
improve the usefulness, timeliness, usability, and accessibility of
OIG's resources. In addition, to ensure that we receive specific
feedback relevant to each category of OIG resources described here,
sections III.B through III.J each have two parts. First, we summarize
each category of OIG resources to establish a common understanding.
Second, we pose specific questions relevant to each category. For some
categories, the RFI asks questions to assess how stakeholders access
and use OIG's resources, as well as questions to assess whether new or
updated resources are needed. For other categories, such as OIG audit
and evaluation reports, we ask questions only about the format of such
information but do not request ideas for specific products (e.g.,
audits or evaluations).
Respondents are urged to address those questions most relevant to
them and do not need to respond to every question.
To aid OIG's review of responses, it would be helpful if
respondents structured their responses using the same lettering and
numbering system we use here.
A. OIG Resources: General Questions
The following questions seek input about OIG's general approach to
providing publicly available resources that may improve the usefulness,
timeliness, usability, and accessibility of OIG's resources across
categories. Questions 1 through 8 relate to OIG's current resources and
web page. Questions 9 through 11 relate to how technology or modern
approaches to data analysis could enhance the usability and
accessibility of OIG's public data and information. Subsequent sections
of this RFI seek information about particular OIG resources, as
described in each section.
1. What OIG resources have you or your organization found most
useful, and why are they most useful? Why have you and your
organization found some resources more useful than others?
2. What types of arrangements or practices, topical areas, or
industry segments should OIG consider addressing in future resources?
From your perspective, which of these are most important or urgent for
OIG to address?
3. What other forms or formats should OIG consider adopting in
future compliance resources? Possible form and format of guidance and
resource materials could include, for example, interactive content
tools, guidance published in the Federal Register, video trainings, or
podcasts. What do you suggest are effective ways for OIG to seek input
from industry stakeholders and the public when developing resource
materials?
4. In addition to OIG's annual solicitation of new safe harbors and
special fraud alerts, do you have any suggestions for another formal
mechanism for industry stakeholders and the public to request OIG
guidance or resources on specific topics or for a particular industry
sector?
5. What type of data or other information could OIG provide to the
health care industry to facilitate compliance and program integrity
efforts?
6. Please provide any suggestions to help improve accessibility and
usability of our content for individuals with disabilities.
7. OIG currently uses its website, email newsletter, and social
media platforms to make the public aware of new resources. Are there
any other methods of communication OIG should consider to inform the
public regarding new or updated resources?
8. Does your organization currently, or plan to, integrate OIG's
publicly available data and information related to compliance with
other functional areas of your organization, such as organizational
financial information? If so, please describe how OIG's publicly
available data and information is or could be most useful for such
integration.
9. How is your organization using application programming
interfaces (APIs) to automate functions that may relate to compliance
or similar issues? For example, have you automated pre-authorization
functions using APIs with payors? Would those functions benefit from
automated functions related to use of OIG's public data and
information?
10. Are there other types of technology that your organization is
considering using to improve its compliance program or other related
functions, such as using machine learning or artificial intelligence to
automate assessment of claims for error before submission? Do these
efforts use OIG's public data and information, or would they benefit
from such data if made more useable and accessible?
B. OIG Advisory Opinions
Pursuant to section 1128D of the Act, HHS, through OIG, publishes
advisory opinions regarding the application of the Federal anti-
kickback statute and the safe harbor provisions, as well as OIG's
administrative sanction authorities, to parties' proposed or existing
arrangements. More specifically, OIG, in consultation with the
Department of Justice (DOJ), issues written advisory opinions to
requesting parties with regard to: (i) What constitutes prohibited
remuneration under the Federal anti-kickback statute; (ii) whether an
arrangement or proposed arrangement satisfies the criteria in section
1128B(b)(3) of the Act, or established by regulation (i.e., safe
harbors), for activities that do not result in prohibited remuneration;
(iii) what constitutes an inducement to reduce or limit services to
Medicare or Medicaid program beneficiaries under section 1128A(b) of
the Act; and (iv) whether an activity or proposed activity constitutes
grounds for the imposition of sanctions under sections 1128, 1128A, or
1128B of the Act.
To implement and interpret section 1128D of the Act, OIG issued an
interim final rule with comment period in 1997.\3\ We revised and
clarified our regulations in a final rule issued in 1998.\4\ In 2008,
we revised certain procedural requirements for submitting payments for
advisory opinion costs.\5\
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\3\ 62 FR 7350 (Feb. 19, 1997).
\4\ 63 FR 38311 (July 16, 1998).
\5\ 73 FR 15937 (Mar. 26, 2008); 73 FR 40982 (July 17, 2008).
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Since OIG implemented the advisory opinion process in 1997, OIG has
issued nearly 400 advisory opinions, modified 21 advisory opinions,
terminated 4
[[Page 53075]]
opinions, and rescinded 1 opinion. During this time, OIG has received
far more advisory opinion requests than these numbers may suggest, over
1,200 requests. For various reasons, including a requestor's withdrawal
of a request or OIG's rejection of a request pursuant to its regulatory
authority, not all requests submitted ultimately result in a published
advisory opinion.
The procedures governing the submission of advisory opinion
requests by an individual or entity in accordance with section 1128D of
the Act are set forth in part 1008 of title 42 of the Code of Federal
Regulations. These regulations impose content-oriented requirements for
advisory opinion requests. For example, requests must contain certain
information, such as ``[a] complete and specific description of all
relevant information bearing on the arrangement,'' and specific
certifications.\6\ The regulations also describe topics that are not
appropriate for an advisory opinion and circumstances in which OIG will
not accept a request or will not issue an opinion, such as when the
same or substantially the same course of action is under investigation
or is or has been the subject of a proceeding involving HHS or another
governmental agency.\7\
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\6\ 42 CFR 1008.36.
\7\ 42 CFR 1008.15(c).
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Section 1128D(b) of the Act provides that advisory opinions will be
issued no later than 60 days after the request is received.\8\ Notably,
however, the regulations governing this process establish triggering
events that toll the time period for issuing an advisory opinion.\9\
The length of time that it takes for OIG to issue an opinion varies
based on a number of factors, including the complexity of the
arrangement, the completeness of the request submission, and the
promptness of requesting parties in responding to requests for
additional information.
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\8\ Section 1128D(b)(5)(B)(1) of the Act.
\9\ 42 CFR 1008.33, 1008.39, 1008.41, 1008.43.
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As described above, not every request we receive results in an
advisory opinion issued by OIG. For example, a requesting party may
withdraw a request at any time before OIG issues an advisory
opinion.\10\ If a request is not withdrawn or rejected, OIG prepares an
advisory opinion in consultation with its Government partners,
including DOJ. After issuing an opinion to the requesting party, OIG
posts a redacted version of the opinion to its website,\11\ removing
identifying information, such as the names of the parties. After an
opinion is published, OIG has the right to reconsider the questions
involved in the advisory opinion, and where the public interest
requires, to rescind, terminate, or modify the advisory opinion.\12\
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\10\ 42 CFR 1008.40.
\11\ See 42 CFR 1008.47(a).
\12\ 42 CFR 1008.45.
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1. Please describe your or your organization's experience, if any,
with the current advisory opinion process. What has worked well, and
what suggestions do you have for improving the process?
2. If you have ever considered submitting an advisory opinion
request and elected not to do so, why did you not submit a request?
What concerns, if any, do you have about the process and how might OIG
address those concerns?
3. OIG advisory opinions currently include a thorough explanation
of the facts and circumstances of the proposed or ongoing arrangement
and a detailed analysis that comprehensively assesses the arrangement
or proposed arrangement under the relevant authorities. In the past,
OIG has received informal feedback that the advisory opinion process
may be too restrictive, slow, or cumbersome. We are seeking your input
on how to balance the value and utility of including detailed analyses
in advisory opinions--which necessitates a more involved and time-
consuming process--with the value and utility of a more expeditious
process that does not necessarily include a detailed legal analysis in
each published opinion. Please share your feedback on the approach that
would be most valuable for you and your organization. For example,
would a short-form advisory opinion that answers the legal questions
posed to OIG without providing a comprehensive legal analysis be useful
to you and your organization? If so, should OIG implement short-form
advisory opinions: (i) For all advisory opinions; (ii) for unfavorable
advisory opinions only; (iii) for any request for which the requesting
party or parties elected, at the beginning of the advisory opinion
process, to receive a short-form opinion; or (iv) for other categories
of opinions?
4. Are there types of arrangements or other circumstances in which
an FAQ process, similar to the COVID-19 FAQ process, would be a
preferable alternative to the advisory opinion process? From your
perspective, what types of arrangements or what other circumstances
would be amenable to an FAQ process as opposed to the existing advisory
opinion process? If OIG implemented an FAQ process that functioned as
an alternative to the advisory opinion process, should OIG charge for
that process, and if so, how should OIG determine such charges?
5. When requesting parties make significant modifications to the
facts presented in the advisory opinion request during the advisory
opinion process, such modifications can delay the process and result in
the expenditure of additional OIG resources. To address this, OIG could
require requesting parties to withdraw (with the opportunity to
resubmit) a request when requesting parties make significant
modifications to the facts presented in the initial request.
Alternatively, OIG could restrict requesting parties from making any
modifications to the original advisory opinion request. Please share
your perspectives on the benefits or drawbacks of each approach.
6. OIG is considering modifying its advisory opinion fee structure.
Revisions could include, for example, a tiered-cost structure, such as
set fee amounts for requests of low, medium, or high complexity;
requesting a retainer or other initial payment upon submission of a
request; and waiving fees for requests withdrawn before a certain point
in the process. Please share any feedback or other ideas on how OIG
might structure and apply fees for advisory opinions in the future.
7. OIG is considering whether to set ``expiration dates'' for
advisory opinions, at which point the advisory opinion would no longer
be in effect. Alternatively, OIG could require requesting parties to
recertify that the facts presented in an advisory opinion are still
true and correct and constitute a complete description of the facts
regarding the arrangement for which an advisory opinion was sought,
where the failure to submit a recertification would result in the
advisory opinion being terminated. Please share your thoughts on the
relative benefits or drawbacks of either approach as well as
considerations in setting timeframes for expiration or recertification
of advisory opinions.
C. Fraud Alerts (Including Special Fraud Alerts)
With respect to special fraud alerts, pursuant to section 1128D(c)
of the Act, ``any person may present a request at any time to [OIG] for
a [special fraud alert that would inform] the public of practices [that
OIG] considers to be suspect or of particular concern under Medicare or
a State health care program.'' OIG may elect to issue special fraud
alerts in response to such requests, or otherwise, at OIG's discretion.
For the most part, special fraud alerts have focused on national
[[Page 53076]]
fraud and abuse trends in health care and address potential violations
of the Federal anti-kickback statute and Beneficiary Inducements CMP.
In developing these special fraud alerts, we rely on a number of
sources, such as studies or management and program evaluations
conducted by OIG's Office of Evaluation and Inspections (OEI). In
addition, we may consult with experts in the subject field, including
those within OIG, other HHS agencies, other Federal and State agencies,
and others in the health care industry. Most recently, OIG released an
alert in 2020 highlighting the fraud and abuse risks associated with
the offer, payment, solicitation, or receipt of remuneration relating
to speaker programs by pharmaceutical and medical device companies.\13\
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\13\ OIG, Special Fraud Alert: Speaker Programs (Nov. 16, 2020),
available at <a href="https://oig.hhs.gov/fraud/docs/alertsandbulletins/2020/SpecialFraudAlertSpeakerPrograms.pdf">https://oig.hhs.gov/fraud/docs/alertsandbulletins/2020/SpecialFraudAlertSpeakerPrograms.pdf</a>.
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In addition to the foregoing, section 1128D(a) of the Act requires
HHS to develop and publish an annual notification in the Federal
Register, which it does through OIG, formally soliciting proposals for
the development of new special fraud alerts or adding to or modifying
existing safe harbors to the Federal anti-kickback statute.
OIG also issues a variety of other fraud alerts, including alerts
that warn the public about fraud schemes OIG has identified (e.g.,
COVID-19 scams).\14\
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\14\ OIG, Fraud Alert: COVID-19 Scams (last updated on Aug. 16,
2021), available at <a href="https://oig.hhs.gov/fraud/consumer-alerts/fraud-alert-covid-19-scams/">https://oig.hhs.gov/fraud/consumer-alerts/fraud-alert-covid-19-scams/</a>.
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1. Which fraud alerts, if any, have you or your organizations used
as a resource, and how have you used them?
2. What could OIG do differently to make our fraud alerts more
meaningful, useful, or timely?
D. Special Advisory Bulletins
Special advisory bulletins cover a variety of topics, including
discussions regarding: (i) Potentially abusive health care industry
practices, similar to those described in special fraud alerts, but
where OIG may lack the enforcement experience necessary to substantiate
a special fraud alert; (ii) the importance of robust compliance
measures, as applied to specific types of arrangements; (iii)
arrangements that potentially implicate the Federal anti-kickback
statute and OIG's administrative enforcement authorities; and (iv) the
scope and effect of certain legal prohibitions. Examples include a 2014
notice, issued concurrently with a related report by OEI, regarding
pharmaceutical manufacturers' offer of copayment coupons to insured
patients \15\ and a bulletin in 2013 describing the effect of exclusion
from participation in Federal health care programs.\16\
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\15\ OIG, Special Advisory Bulletin: Pharmaceutical Manufacturer
Copayment Coupons (Sept. 2014), available at <a href="https://oig.hhs.gov/fraud/docs/alertsandbulletins/2014/SAB_Copayment_Coupons.pdf">https://oig.hhs.gov/fraud/docs/alertsandbulletins/2014/SAB_Copayment_Coupons.pdf</a>.
\16\ OIG, Updated Special Advisory Bulletin on the Effect of
Exclusion from Participation in Federal Health Care Programs (May 8,
2013), available at <a href="https://oig.hhs.gov/exclusions/files/sab-05092013.pdf">https://oig.hhs.gov/exclusions/files/sab-05092013.pdf</a>.
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1. Which special advisory bulletins, if any, have you or your
organization used as a resource and how have you used them?
2. What could OIG do differently to make our special advisory
bulletins more meaningful, useful, or timely?
3. If OIG were to update existing special advisory bulletins or
publish additional special advisory bulletins on certain topic areas,
how should OIG best obtain stakeholder input on areas in need of new
guidance or refinements to existing guidance?
E. Compliance Program Guidance
As a general matter, CPGs set forth OIG's views on the value and
fundamental principles of a compliance program, in addition to elements
for consideration when developing and implementing an effective
compliance program. CPGs are intended to encourage the voluntary
development and use of internal controls to monitor adherence to
applicable statutes, regulations, and program requirements. Beginning
in 1998, OIG developed a series of CPGs directed at a number of
different segments of the health care industry, including, for example,
nursing facilities, hospitals, and pharmaceutical manufacturers.\17\ As
stated in each CPG, the suggestions included in the CPGs are not
mandatory, and the CPGs are not intended to be an exhaustive discussion
of beneficial compliance practices or relevant risk areas.
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\17\ E.g., OIG Supplemental Compliance Program Guidance for
Nursing Facilities, 73 FR 56832 (Sept. 30, 2008); OIG Supplemental
Compliance Program Guidance for Hospitals, 70 FR 4848 (Jan. 31,
2005); OIG Compliance Program Guidance for Pharmaceutical
Manufacturers, 68 FR 23731 (May 5, 2003).
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1. How, if at all, do you or your organization use the CPGs to
understand beneficial compliance practices or relevant risk areas?
2. If OIG published additional or supplemental CPGs, or resources
similar to CPGs, what industry segments would you find most useful for
us to address?
3. If OIG were to update or publish additional or supplemental
CPGs, how should OIG best solicit stakeholder input about risk areas or
other features to update or supplement?
4. What suggestions, if any, do you have for the form, format, or
content for CPGs to make them as useful, relevant, and timely as
possible? For example, instead of a static document, would it be more
useful, relevant, and timely to have a mobile-friendly web page that is
updated at regular intervals to describe compliance best practices and
current risk areas?
F. Frequently Asked Questions, Including COVID-19 Frequently Asked
Questions
In response to the COVID-19 public health emergency, OIG developed
a process to respond to inquiries from health care industry
stakeholders regarding the application of the Federal anti-kickback
statute and OIG's administrative enforcement authorities to
arrangements directly connected to the COVID-19 public health
emergency.\18\ Through this FAQ process, OIG has received and reviewed
questions submitted by a variety of health care stakeholders, and where
OIG has determined that it would be appropriate and beneficial, we have
provided informal feedback, time limited to the duration of the COVID-
19 public health emergency,\19\ explaining OIG's assessment of whether
a particular arrangement poses a sufficiently low risk of fraud and
abuse under the Federal anti-kickback statute, the Beneficiary
Inducements CMP, or both. OIG developed this FAQ process consistent
with the agency's mission to promote economy, efficiency, and
effectiveness in HHS programs and to further OIG's commitment to
protecting patients by ensuring that health care providers and others
have the regulatory flexibility necessary to adequately respond to
COVID-19 concerns. Recognizing the importance of expeditious feedback
in the context of a public health emergency, when OIG has
[[Page 53077]]
responded to questions, it has aimed to do so quickly.
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\18\ OIG, FAQs--Application of OIG's Administrative Enforcement
Authorities to Arrangements Directly Connected to the Coronavirus
Disease 2019 (COVID-19) Public Health Emergency, available at
<a href="https://oig.hhs.gov/coronavirus/authorities-faq.asp">https://oig.hhs.gov/coronavirus/authorities-faq.asp</a>.
\19\ The Secretary of HHS determined, through a January 31,
2020, determination, pursuant to section 319 of the Public Health
Service Act, that a public health emergency exists and has existed
since January 27, 2020. See U.S. Department of Health and Human
Services, Determination that a Public Health Emergency Exists (Jan.
31, 2020), available at <a href="https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx">https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx</a> (COVID-19 Declaration). The
Secretary has issued subsequent 90-day renewals of that original
determination. The duration of the COVID-19 public health emergency
is tied to these determinations.
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1. How, if at all, do you or your organization use the COVID-19 FAQ
responses in assessing or structuring arrangements directly connected
to the COVID-19 public health emergency that potentially implicate
OIG's administrative enforcement authorities? Do you have any feedback
on how OIG can make the COVID-19 FAQ responses more useful?
2. Would you or your organization find it valuable if OIG
established an FAQ process modeled after the COVID-19 FAQ process that
would continue after the COVID-19 public health emergency ends? What
suggestions, if any, do you have for the structure of any FAQs, the
process for submitting questions, or the topics such process would
address?
3. What could OIG do differently to make an FAQ process for public
health emergencies or other inquiries more meaningful, useful, or
timely in the future?
G. Other Compliance Guidance and Resources
OIG has published numerous other compliance-related documents that
target various segments of the health care industry. For example, OIG
published ``A Roadmap for New Physicians: Avoiding Medicare and
Medicaid Fraud and Abuse'' \20\ to help new physicians understand the
application of certain Federal fraud and abuse laws, including OIG's
administrative enforcement authorities and how they protect Federal
health care programs and their beneficiaries from fraud and abuse. We
also have developed guidance documents specific to health care boards,
including resources jointly published by OIG and professional
associations.\21\ Although most of OIG's resources are written
materials, we also have published video trainings developed as part of
the Health Care Fraud Prevention and Enforcement Action Team Provider
Compliance Training initiative \22\ and podcasts on various compliance
topics.\23\
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\20\ OIG, A Roadmap for New Physicians: Avoiding Medicare and
Medicaid Fraud and Abuse, available at <a href="https://oig.hhs.gov/compliance/physician-education/roadmap_web_version.pdf">https://oig.hhs.gov/compliance/physician-education/roadmap_web_version.pdf</a>.
\21\ E.g., HCCA[hyphen]OIG Compliance Effectiveness Roundtable,
Measuring Compliance Program Effectiveness-A Resource Guide (Mar.
27, 2017), available at <a href="https://oig.hhs.gov/compliance/compliance-resource-portal/files/HCCA-OIG-Resource-Guide.pdf">https://oig.hhs.gov/compliance/compliance-resource-portal/files/HCCA-OIG-Resource-Guide.pdf</a>.
\22\ OIG, HEAT Provider Compliance Training Videos, available at
<a href="https://oig.hhs.gov/newsroom/video/2011/heat_modules.asp">https://oig.hhs.gov/newsroom/video/2011/heat_modules.asp</a>.
\23\ E.g., OIG, Podcasts, What Role Does Data Play in Fighting
Healthcare Fraud, Waste, and Abuse? (June 7, 2016), available at
<a href="https://oig.hhs.gov/newsroom/oig-podcasts/what-role-does-data-play-fighting-healthcare-fraud-waste-and-abuse">https://oig.hhs.gov/newsroom/oig-podcasts/what-role-does-data-play-fighting-healthcare-fraud-waste-and-abuse</a>.
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1. How, if at all, do you and your organization use OIG's other
compliance resources, like our video trainings and podcasts? If you or
your organization do not use these resources, please explain why.
2. What, if anything, could OIG do to make our other compliance
resources more useful, relevant, and timely?
H. Corporate Integrity Agreements
OIG negotiates CIAs with individuals and entities as part of the
settlement of Federal health care program investigations arising under
a variety of civil false claims statutes. Individuals and entities
agree to the obligations set forth in the CIAs, and in exchange, OIG
agrees not to seek their exclusion from participation in Medicare,
Medicaid, or other Federal health care programs under section
1128(b)(7) of the Act. OIG negotiates each CIA with the specific party
or parties to the CIA, and each CIA is binding only on the party or
parties to the CIA. However, OIG recognizes that industry stakeholders
may review CIAs in the development or refinement of a compliance
program and to facilitate an understanding of compliance best
practices. In addition, OIG's website includes various materials
related to CIAs. For example, OIG posts all open CIAs and maintains a
list of closed CIAs.\24\ In addition, OIG has issued CIA-specific FAQs
and has published guidance on the independence and objectivity
requirements relating to independent review organizations retained
under CIAs.\25\ OIG publishes CIA documents on our website so that
industry stakeholders can use them as a resource in developing the
essential elements of a compliance program. As noted above, each CIA is
negotiated as part of an individual civil settlement and is binding
only on the parties to the CIA.
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\24\ OIG, Corporate Integrity Agreement Documents, available at
<a href="https://oig.hhs.gov/compliance/corporate-integrity-agreements/cia-documents.asp">https://oig.hhs.gov/compliance/corporate-integrity-agreements/cia-documents.asp</a>.
\25\ E.g., OIG, Corporate Integrity Agreement FAQ, available at
<a href="https://oig.hhs.gov/faqs/corporate-integrity-agreements-faq.asp">https://oig.hhs.gov/faqs/corporate-integrity-agreements-faq.asp</a>.
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1. How do you or your organization use the information in publicly
available CIAs?
2. What types of search capabilities for CIA documents (e.g.,
search by provider type) would be most useful for your or your
organization?
I. List of Excluded Individuals/Entities
OIG has the authority to exclude individuals and entities from
federally funded health care programs pursuant to section 1128 of the
Act (and from Medicare and State health care programs under section
1156 of the Act) and maintains a list of all currently excluded
individuals and entities called the LEIE. Anyone who hires an
individual or entity on the LEIE may be subject to CMPs. To avoid CMP
liability, health care entities need to routinely check the LEIE to
ensure that new hires and current employees are not on the excluded
list.
The LEIE website receives approximately 26 million visits annually.
Users can check the LEIE through two primary means: downloading a
spreadsheet or using web queries for up to five providers at a time. We
believe that the number of annual visits combined with the mostly
manual interaction with the LEIE means there is considerable
opportunity to reduce burden and lower costs associated with checking
the LEIE. Additionally, modern data sharing practices, such as APIs and
better structured data, provide options to improve how users can access
and use the LEIE data.
1. How can OIG best provide access to the LEIE? For example, if OIG
publishes an API for the LEIE, would that be useful to you or your
organization? Are there other access options or data formats that would
make using the LEIE easier?
2. What software or application, if any, do you currently use to
check the LEIE? Is that software or application developed internally or
by a third party? Does the software or application automate the process
of checking the LEIE?
3. Do you integrate the results of the LEIE with other information,
such as information related to provider onboarding, licensure,
credentialing, or privileging? If yes, please explain how.
J. OIG Audits and Evaluations
OIG audits examine the performance of HHS programs and/or its
grantees, contractors, or providers in carrying out their respective
responsibilities and provide independent assessments of HHS programs
and operations. OIG also conducts national evaluations to provide HHS,
Congress, the public, and other stakeholders with timely, useful, and
reliable assessments of HHS programs and operations. OIG's audits and
evaluations provide detailed findings and often include recommendations
to Federal and State agencies, health care providers, HHS grantees,
contractors, and other entities. In addition, OIG's reports can provide
information, data, or methodologies that health care providers and
other entities
[[Page 53078]]
can use to support their own internal audit and evaluation programs.
Most of OIG's reports are made available publicly on OIG's website.
For some reports, OIG makes certain downloadable resources and
applications available to the public, and OIG has published
supplemental information to enable stakeholders to adapt the audit or
evaluation methodology for their own use or to provide access to key
data related to our findings. For example, OIG issued toolkits that
provide detailed steps and programming code for using prescription drug
claims data to analyze patients' opioid levels to identify certain
patients at risk of opioid misuse or overdose.\26\ In another example,
OIG provided an interactive map online that enables users to see, by
county, data on the need for opioid treatment services overlaid with
data on the availability of buprenorphine services (medication-assisted
treatment).\27\
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\26\ HHS OIG Toolkits for Calculating Opioid Levels and
Identifying Patients at Risk of Misuse or Overdose, available at
<a href="https://oig.hhs.gov/oei/reports/oei-02-17-00560.asp">https://oig.hhs.gov/oei/reports/oei-02-17-00560.asp</a>.
\27\ OIG, Geographic Disparities Affect Access to Buprenorphine
Services for Opioid Use Disorder (OEI-12-17-00240) (Jan. 2020),
available at <a href="https://oig.hhs.gov/oei/reports/oei-12-17-00240.asp">https://oig.hhs.gov/oei/reports/oei-12-17-00240.asp</a>.
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OIG audit and evaluation reports are available on our website and
can be downloaded as PDFs. In recent years, OIG has refreshed the
format and layout of our reports with the goal of making them more user
friendly; for example, most reports start with a ``Report in Brief''
that provides the key findings, recommendations, and context on the
first page. We have also used different formats for certain types of
reports, such as a ``data brief'' \28\ and a ``data snapshot,'' \29\
among others, with the intent of making the key results and takeaways
clearer and more readily understood.
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\28\ E.g., OIG, Concerns Persist About Opioid Overdoses and
Medicare Beneficiaries' Access to Treatment and Overdose-Reversal
Drugs (OEI-02-20-00401) (Aug. 2021), available at <a href="https://oig.hhs.gov/oei/reports/OEI-02-20-00401.asp">https://oig.hhs.gov/oei/reports/OEI-02-20-00401.asp</a>.
\29\ E.g., OIG, National Review of Opioid Prescribing in
Medicaid Is Not Yet Possible (OEI-05-18-00480) (Aug. 2019),
available at <a href="https://oig.hhs.gov/oei/reports/oei-05-18-00480.asp">https://oig.hhs.gov/oei/reports/oei-05-18-00480.asp</a>.
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OIG also publishes other information and resources describing
forthcoming reports or summarizing published reports. For example, OIG
publishes a Work Plan on our website, which is a searchable repository
of our ongoing audits and evaluations, updated monthly, with archived
information on completed work plan items that link to their resulting
products.\30\ OIG also publishes the agency's Semiannual Report to
Congress.\31\ Finally, OIG is developing a new tracking system for our
recommendations. We intend to make available on our website a
searchable repository of OIG recommendations from our audits and
evaluations, including information about the status of their
implementation.
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\30\ OIG Work Plan, available at <a href="https://oig.hhs.gov/reports-and-publications/workplan/index.asp">https://oig.hhs.gov/reports-and-publications/workplan/index.asp</a>.
\31\ OIG Semiannual Report to Congress, available at <a href="https://oig.hhs.gov/reports-and-publications/semiannual/index.asp">https://oig.hhs.gov/reports-and-publications/semiannual/index.asp</a>.
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1. How could OIG facilitate better utilization of data and data
analysis through its toolkits or other resources?
2. How could OIG use its toolkits or other resources to help
providers and others identify compliance risks or improve upon their
compliance programs?
3. To facilitate the monitoring and automation of compliance best
practices, would it be helpful to share the data methodology or
programming codes employed by OIG in certain of its audit or evaluation
reports, similar to OIG's Toolkits for Calculating Opioid Levels and
Identifying Patients at Risk of Misuse or Overdose? \32\
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\32\ HHS OIG Toolkits for Calculating Opioid Levels and
Identifying Patients at Risk of Misuse or Overdose, available at
<a href="https://oig.hhs.gov/oei/reports/oei-02-17-00560.asp">https://oig.hhs.gov/oei/reports/oei-02-17-00560.asp</a>.
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4. Please share any feedback on accessing OIG audit and evaluation
reports. For example, how easy is it for you to find specific reports
when you look for them? How well does the downloadable PDF format work
for you? Are there other file types or web-based formats that would be
more accessible or useful to you?
5. Please share any feedback on the ways we present information in
OIG audit and evaluation reports, including our more standard reporting
templates and our alternative formats, such as data briefs and data
snapshots. For example, what types of information (e.g., key takeaways,
findings, recommendations, methodology) are most useful to you? How
easy is it to find and understand that information? What suggestions,
if any, do you have for making our reports more useful or user friendly
in their presentation?
6. Please tell us about your experiences, if any, in using
supplemental products such as OIG Toolkits or Interactive Maps that
sometimes accompany audit or evaluation reports. What have you found
most valuable, if anything, about these supplemental products? What
could we improve to make these products more valuable to you? Please
also share any ideas for other types of supplemental products for OIG
to consider developing that would be useful to you.
7. Please share feedback on your experiences, if any, in accessing
and using the OIG Work Plan. For example, how well can you find the
information that you are looking for? How, if at all, do you or your
organization use the information in our Work Plan?
8. As OIG develops our searchable repository of recommendations for
our public website, we would appreciate any feedback you have on how to
make this repository most useful to you or your organization. For
example, what types of queries would you want to run, what types of
information might you be looking for, and what functionalities would
you want this system to have?
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, 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.
[[Page 53079]]
IV. Collection of Information Requirements
This document does not impose information collection requirements,
that is, reporting, recordkeeping, or third-party disclosure
requirements under the Paperwork Reduction Act of 1995 (PRA). 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 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 collections and therefore not subject to the
PRA. Consequently, there is no need for review by the Office of
Management and Budget under the authority of the PRA.
V. Response to Comments
Because of the large number of public comments we normally receive
in response to 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. Publication
of this RFI does not commit OIG to the promulgation of new regulations
or issuance of new guidance.
Christi A. Grimm,
Principal Deputy, Inspector General.
[FR Doc. 2021-20558 Filed 9-23-21; 8:45 am]
BILLING CODE 4152-01-P
</pre></body>
</html>Indexed from Federal Register on September 24, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.