OIG Modernization Initiative To Improve Its Publicly Available Resources-Request for Information, 53072-53079 [2021-20558]

Download as PDF 53072 Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Notices Æ Reformat/separate Statutory Funding Preference data from Special Consideration data. • Table #2 has: Æ ‘‘Students’’ reworded to ‘‘participants/trainees;’’ Æ One column labeled, ‘‘Budget Year,’’ to identify the project budget year; Æ One column to create a space for entering the sum for each row; Æ Rows to more clearly indicate the budget year for up to 5 years; and, Æ One final row to create a space for entering the total for each column. • Frequency of data collection: Data is collected (through the two tables) once during the application period for each funding announcement. • Information determines: Æ If applicants meet the funding preference or special consideration for funding, and Æ Projected target and baseline numbers of trainees/participants to be supported throughout the project period. Likely Respondents: Likely respondents will be current ANE Programs awardees and new applicants to the ANE Programs. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose, or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below. TOTAL ESTIMATED ANNUALIZED BURDEN HOURS Form name (includes the ANE program specific tables and attachments) Number of respondents Number of responses per respondent Total responses Average burden per response (in hours) Total burden hours ANEW .................................................................................. NAT ...................................................................................... ANE–NPR ............................................................................ ANE–NPRIP ......................................................................... ANE–SANE .......................................................................... 236 115 101 15 54 1 1 1 1 1 236 115 101 15 54 7 7 7 7 7 1,652 805 707 105 378 Total .............................................................................. 521 ........................ 521 ........................ 3,647 HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Maria G. Button, Director, Executive Secretariat. [FR Doc. 2021–20653 Filed 9–23–21; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of Inspector General OIG Modernization Initiative To Improve Its Publicly Available Resources—Request for Information Office of Inspector General (OIG), HHS. AGENCY: ACTION: Request for information. This request for information seeks input from the public on OIG resources and how OIG could enhance the usefulness and timeliness of such SUMMARY: VerDate Sep<11>2014 16:50 Sep 23, 2021 Jkt 253001 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. PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 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 highvalue changes. Input collected from this RFI will help inform decisions about which areas to address first. By tailoring our resources in response to stakeholder E:\FR\FM\24SEN1.SGM 24SEN1 Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Notices 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: • 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; • State officials who administer or oversee Medicaid and other State health care programs; • Tribal officials and providers and suppliers serving American Indian and Alaska Native communities; • health care consumers and their advocates; and • 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: • Advisory opinions; • fraud alerts (including special fraud alerts); • special advisory bulletins; • compliance program guidance; • frequently asked questions (FAQs), including COVID–19 FAQs; • other compliance guidance and resources; • corporate integrity agreements (CIAs); • the list of excluded individuals/ entities (LEIE); and • audits and evaluations. II. RFI Objectives For 45 years, OIG has provided objective, independent information to the public to foster an improved VerDate Sep<11>2014 16:50 Sep 23, 2021 Jkt 253001 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 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 53073 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-andcomment 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 antikickback 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 1 Section 1128B(b) of the Social Security Act (the Act). 2 Section 1128A(a)(5) of the Act. E:\FR\FM\24SEN1.SGM 24SEN1 53074 Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Notices provide information to encourage compliance best practices (e.g., compliance program guidance documents (CPGs) and compliancefocused toolkits), and others are intended to explain OIG’s legal interpretations of the Federal antikickback 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. 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 VerDate Sep<11>2014 16:50 Sep 23, 2021 Jkt 253001 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 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 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 preauthorization 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 Since OIG implemented the advisory opinion process in 1997, OIG has issued nearly 400 advisory opinions, modified 21 advisory opinions, terminated 4 3 62 FR 7350 (Feb. 19, 1997). FR 38311 (July 16, 1998). 5 73 FR 15937 (Mar. 26, 2008); 73 FR 40982 (July 17, 2008). 4 63 E:\FR\FM\24SEN1.SGM 24SEN1 Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Notices 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 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. 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 6 42 CFR 1008.36. CFR 1008.15(c). 8 Section 1128D(b)(5)(B)(1) of the Act. 9 42 CFR 1008.33, 1008.39, 1008.41, 1008.43. 10 42 CFR 1008.40. 11 See 42 CFR 1008.47(a). 7 42 VerDate Sep<11>2014 16:50 Sep 23, 2021 Jkt 253001 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 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 12 42 PO 00000 CFR 1008.45. Frm 00048 Fmt 4703 Sfmt 4703 53075 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 E:\FR\FM\24SEN1.SGM 24SEN1 53076 Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Notices 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 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 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 13 OIG, Special Fraud Alert: Speaker Programs (Nov. 16, 2020), available at https://oig.hhs.gov/ fraud/docs/alertsandbulletins/2020/SpecialFraud AlertSpeakerPrograms.pdf. 14 OIG, Fraud Alert: COVID–19 Scams (last updated on Aug. 16, 2021), available at https:// oig.hhs.gov/fraud/consumer-alerts/fraud-alertcovid-19-scams/. VerDate Sep<11>2014 16:50 Sep 23, 2021 Jkt 253001 coupons to insured patients 15 and a bulletin in 2013 describing the effect of exclusion from participation in Federal health care programs.16 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. 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 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/sab05092013.pdf. 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). PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 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 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. E:\FR\FM\24SEN1.SGM 24SEN1 Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Notices responded to questions, it has aimed to do so quickly. 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/physicianeducation/roadmap_web_version.pdf. 21 E.g., HCCA-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-OIGResource-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? VerDate Sep<11>2014 16:50 Sep 23, 2021 Jkt 253001 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. 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 (June 7, 2016), available at https://oig.hhs.gov/ newsroom/oig-podcasts/what-role-does-data-playfighting-healthcare-fraud-waste-and-abuse. 24 OIG, Corporate Integrity Agreement Documents, available at https://oig.hhs.gov/ compliance/corporate-integrity-agreements/ciadocuments.asp. 25 E.g., OIG, Corporate Integrity Agreement FAQ, available at https://oig.hhs.gov/faqs/corporateintegrity-agreements-faq.asp. PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 53077 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 E:\FR\FM\24SEN1.SGM 24SEN1 53078 Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Notices 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 (medicationassisted treatment).27 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. 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 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. 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. 30 OIG Work Plan, available at https:// oig.hhs.gov/reports-and-publications/workplan/ index.asp. VerDate Sep<11>2014 16:50 Sep 23, 2021 Jkt 253001 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. 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 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 31 OIG Semiannual Report to Congress, available at https://oig.hhs.gov/reports-and-publications/ semiannual/index.asp. 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. PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 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. E:\FR\FM\24SEN1.SGM 24SEN1 Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Notices 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Notice of Diabetes Mellitus Interagency Coordinating Committee Meeting AGENCY: National Institutes of Health, HHS. ACTION: Notice. The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on SUMMARY: VerDate Sep<11>2014 16:50 Sep 23, 2021 Jkt 253001 November 8, 2021. The topic for this meeting will be ‘‘Evolving Concepts in the Assessment and Management of Hypoglycemia.’’ The meeting is open to the public. DATES: The meeting will be held on November 8, 2021 from 12:00 p.m. to 3:00 p.m. EDT. ADDRESSES: The meeting will be held via the Zoom online video conferencing platform. For details, and to register, please contact dmicc@mail.nih.gov. FOR FURTHER INFORMATION CONTACT: For further information concerning this meeting, including a draft agenda, which will be posted when available, see the DMICC website, www.diabetescommittee.gov, or contact Dr. William Cefalu, Executive Secretary of the Diabetes Mellitus Interagency Coordinating Committee, National Institute of Diabetes and Digestive and Kidney Diseases, 6707 Democracy Boulevard, Democracy 2, Room 6037, Bethesda, MD 20892, telephone: 301– 435–1011; email: dmicc@mail.nih.gov. SUPPLEMENTARY INFORMATION: In accordance with 42 U.S. Code § 285c–3, the DMICC, chaired by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) comprising members of the Department of Health and Human Services and other federal agencies that support diabetes-related activities, facilitates cooperation, communication, and collaboration on diabetes among government entities. DMICC meetings, held several times a year, provide an opportunity for Committee members to learn about and discuss current and future diabetes programs in DMICC member organizations and to identify opportunities for collaboration. The November 8, 2021 DMICC meeting will focus on ‘‘Evolving Concepts in the Assessment and Management of Hypoglycemia.’’ Any member of the public interested in presenting oral comments to the Committee should notify the contact person listed on this notice at least 5 days in advance of the meeting. Interested individuals and representatives or organizations should submit a letter of intent, a brief description of the organization represented, and a written copy of their oral presentation in advance of the meeting. Only one representative of an organization will be allowed to present; oral comments and presentations will be limited to a maximum of 5 minutes. Printed and electronic copies are requested for the record. In addition, any interested person may file written comments with the Committee by forwarding their statement to the PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 53079 contact person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Because of time constraints for the meeting, oral comments will be allowed on a first-come, first-serve basis. Members of the public who would like to receive email notification about future DMICC meetings should register for the listserv available on the DMICC website, www.diabetescommittee.gov. Dated: September 21, 2021. Bruce Tibor Roberts, Health Science Policy Analyst, Office of Scientific Program and Policy Analysis, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health. [FR Doc. 2021–20802 Filed 9–23–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Mental Health Initial Review Group; Mental Health Services Study Section. Date: October 21–22, 2021. Time: October 21, 2021, 12:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Time: October 22, 2021, 11:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Aileen Schulte, Ph.D., Scientific Review Officer, Division of E:\FR\FM\24SEN1.SGM 24SEN1

Agencies

[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:
     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;
     State officials who administer or oversee Medicaid and 
other State health care programs;
     Tribal officials and providers and suppliers serving 
American Indian and Alaska Native communities;
     health care consumers and their advocates; and
     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:
     Advisory opinions;
     fraud alerts (including special fraud alerts);
     special advisory bulletins;
     compliance program guidance;
     frequently asked questions (FAQs), including COVID-19 
FAQs;
     other compliance guidance and resources;
     corporate integrity agreements (CIAs);
     the list of excluded individuals/entities (LEIE); and
     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