[Federal Register Volume 86, Number 183 (Friday, September 24, 2021)]
[Notices]
[Pages 53072-53079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20558]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 http://www.regulations.gov. 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: http://www.regulations.gov. 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

[[Page 53074]]

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.
---------------------------------------------------------------------------

    \1\ Section 1128B(b) of the Social Security Act (the Act).
    \2\ Section 1128A(a)(5) of the Act.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \6\ 42 CFR 1008.36.
    \7\ 42 CFR 1008.15(c).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \8\ Section 1128D(b)(5)(B)(1) of the Act.
    \9\ 42 CFR 1008.33, 1008.39, 1008.41, 1008.43.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \10\ 42 CFR 1008.40.
    \11\ See 42 CFR 1008.47(a).
    \12\ 42 CFR 1008.45.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \13\ OIG, Special Fraud Alert: Speaker Programs (Nov. 16, 2020), 
available at https://oig.hhs.gov/fraud/docs/alertsandbulletins/2020/SpecialFraudAlertSpeakerPrograms.pdf.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \14\ OIG, Fraud Alert: COVID-19 Scams (last updated on Aug. 16, 
2021), available at https://oig.hhs.gov/fraud/consumer-alerts/fraud-alert-covid-19-scams/.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \15\ OIG, Special Advisory Bulletin: Pharmaceutical Manufacturer 
Copayment Coupons (Sept. 2014), available at https://oig.hhs.gov/fraud/docs/alertsandbulletins/2014/SAB_Copayment_Coupons.pdf.
    \16\ OIG, Updated Special Advisory Bulletin on the Effect of 
Exclusion from Participation in Federal Health Care Programs (May 8, 
2013), available at https://oig.hhs.gov/exclusions/files/sab-05092013.pdf.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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 
https://oig.hhs.gov/coronavirus/authorities-faq.asp.
    \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 https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx (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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \20\ OIG, A Roadmap for New Physicians: Avoiding Medicare and 
Medicaid Fraud and Abuse, available at https://oig.hhs.gov/compliance/physician-education/roadmap_web_version.pdf.
    \21\ E.g., HCCA[hyphen]OIG Compliance Effectiveness Roundtable, 
Measuring Compliance Program Effectiveness-A Resource Guide (Mar. 
27, 2017), available at https://oig.hhs.gov/compliance/compliance-resource-portal/files/HCCA-OIG-Resource-Guide.pdf.
    \22\ OIG, HEAT Provider Compliance Training Videos, available at 
https://oig.hhs.gov/newsroom/video/2011/heat_modules.asp.
    \23\ E.g., OIG, Podcasts, What Role Does Data Play in Fighting 
Healthcare Fraud, Waste, and Abuse? (June 7, 2016), available at 
https://oig.hhs.gov/newsroom/oig-podcasts/what-role-does-data-play-fighting-healthcare-fraud-waste-and-abuse.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \24\ OIG, Corporate Integrity Agreement Documents, available at 
https://oig.hhs.gov/compliance/corporate-integrity-agreements/cia-documents.asp.
    \25\ E.g., OIG, Corporate Integrity Agreement FAQ, available at 
https://oig.hhs.gov/faqs/corporate-integrity-agreements-faq.asp.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \26\ HHS OIG Toolkits for Calculating Opioid Levels and 
Identifying Patients at Risk of Misuse or Overdose, available at 
https://oig.hhs.gov/oei/reports/oei-02-17-00560.asp.
    \27\ OIG, Geographic Disparities Affect Access to Buprenorphine 
Services for Opioid Use Disorder (OEI-12-17-00240) (Jan. 2020), 
available at https://oig.hhs.gov/oei/reports/oei-12-17-00240.asp.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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 https://oig.hhs.gov/oei/reports/OEI-02-20-00401.asp.
    \29\ E.g., OIG, National Review of Opioid Prescribing in 
Medicaid Is Not Yet Possible (OEI-05-18-00480) (Aug. 2019), 
available at https://oig.hhs.gov/oei/reports/oei-05-18-00480.asp.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \30\ OIG Work Plan, available at https://oig.hhs.gov/reports-and-publications/workplan/index.asp.
    \31\ OIG Semiannual Report to Congress, available at https://oig.hhs.gov/reports-and-publications/semiannual/index.asp.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \32\ HHS OIG Toolkits for Calculating Opioid Levels and 
Identifying Patients at Risk of Misuse or Overdose, available at 
https://oig.hhs.gov/oei/reports/oei-02-17-00560.asp.
---------------------------------------------------------------------------

    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