Office of Inspector General – Federal Register Recent Federal Regulation Documents

Regulatory Clean Up Initiative
Document Number: 2020-21774
Type: Rule
Date: 2020-11-16
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Food and Drug Administration, Office of the Secretary, Administration for Children and Families, Office of Inspector General
The U.S Department of Health and Human Services (HHS) is amending its regulations to make miscellaneous corrections, including correcting references to other regulations, misspellings and other typographical errors. This document is necessary to inform the public of these non-substantive changes to HHS's regulations.
Grants, Contracts, and Other Agreements: Fraud and Abuse; Information Blocking; Office of Inspector General's Civil Money Penalty Rules
Document Number: 2020-08451
Type: Proposed Rule
Date: 2020-04-24
Agency: Department of Health and Human Services, Office of Inspector General
This proposed rule would amend the civil money penalty (CMP or penalty) rules of the Department of Health and Human Services (HHS or Department) Office of Inspector General (OIG) to: Incorporate new authorities for CMPs, assessments, and exclusions related to HHS grants, contracts, other agreements; incorporate new CMP authorities for information blocking; and increase the maximum penalties for certain CMP violations.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2020-06046
Type: Notice
Date: 2020-03-23
Agency: Department of Health and Human Services, Office of Inspector General
This notice replaces all language in Part Q (Office of the Secretary) of the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services (HHS or the Department), Office of Inspector General (OIG), (published March 15, 2016).
Solicitation of New Safe Harbors and Special Fraud Alerts
Document Number: 2019-27202
Type: Proposed Rule
Date: 2019-12-31
Agency: Department of Health and Human Services, Office of Inspector General
In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notification solicits proposals and recommendations for developing new, or modifying existing, safe harbor provisions under section 1128B(b) of the Social Security Act (the Act), (the anti-kickback statute), as well as developing new OIG Special Fraud Alerts.
Medicare and State Healthcare Programs: Fraud and Abuse; Revisions To Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements
Document Number: 2019-22027
Type: Proposed Rule
Date: 2019-10-17
Agency: Department of Health and Human Services, Office of Inspector General
This proposed rule is being issued by the Office of Inspector General (OIG) in conjunction with the Department of Health and Human Services' Regulatory Sprint to Coordinated Care. It proposes to add, on a prospective basis only after a final rule is issued, safe harbor protections under the Federal anti-kickback statute for certain coordinated care and associated value-based arrangements between or among clinicians, providers, suppliers, and others that squarely meet all safe harbor conditions. It also would add protections under the anti-kickback statute and civil monetary penalty (CMP) law that prohibits inducements offered to patients for certain patient engagement and support arrangements to improve quality of care, health outcomes, and efficiency of care delivery that squarely meet all safe harbor conditions. The proposed rule would add a new safe harbor for donations of cybersecurity technology and amend the existing safe harbors for electronic health records (EHR) arrangements, warranties, local transportation, and personal services and management contracts. Further, the proposed rule would add a new safe harbor pursuant to a statutory change set forth in the Bipartisan Budget Act of 2018 (Budget Act of 2018) related to beneficiary incentives under the Medicare Shared Savings Program and a new CMP exception for certain telehealth technologies offered to patients receiving in-home dialysis, also pursuant to the Budget Act of 2018.
Withdrawal of Proposed Rule “Medicare and State Health Care Programs: Fraud and Abuse; Safe Harbor Under the Anti-Kickback Statute for Waiver of Beneficiary Coinsurance and Deductible Amounts”
Document Number: 2019-16346
Type: Proposed Rule
Date: 2019-08-02
Agency: Department of Health and Human Services, Office of Inspector General
This document informs the public that OIG has determined not to pursue a proposed rule published in the Federal Register and, as a result, is withdrawing it. OIG is taking this action to avoid any confusion that could be caused by having this proposal in the public domain.
Withdrawal of Proposed Rule “Health Care Programs: Fraud and Abuse; Civil Money Penalties for Hospital Physician Incentive Plans”
Document Number: 2019-16343
Type: Proposed Rule
Date: 2019-08-02
Agency: Department of Health and Human Services, Office of Inspector General
This document informs the public that OIG has determined not to pursue a proposed rule published in the Federal Register and, as a result, is withdrawing it. OIG is taking this action to avoid any confusion that could be caused by having this proposal in the public domain.
Program Integrity-Medicare and State Health Care Programs
Document Number: 2019-09856
Type: Rule
Date: 2019-05-13
Agency: Department of Health and Human Services, Office of Inspector General
Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees
Document Number: 2019-01026
Type: Proposed Rule
Date: 2019-02-06
Agency: Department of Health and Human Services, Office of Inspector General
In this proposed rule, the Department of Health and Human Services (Department or HHS) proposes to amend the safe harbor regulation concerning discounts, which are defined as certain conduct that is protected from liability under the Federal anti-kickback statute, section 1128B(b) of the Social Security Act (the Act). The amendment would revise the discount safe harbor to explicitly exclude from the definition of a discount eligible for safe harbor protection certain reductions in price or other remuneration from a manufacturer of prescription pharmaceutical products to plan sponsors under Medicare Part D, Medicaid managed care organizations as defined under section 1903(m) of the Act (Medicaid MCOs), or pharmacy benefit managers (PBMs) under contract with them. In addition, the Department is proposing two new safe harbors. The first would protect certain point-of-sale reductions in price on prescription pharmaceutical products, and the second would protect certain PBM service fees.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2018-23935
Type: Notice
Date: 2018-11-06
Agency: Department of Health and Human Services, Office of Inspector General
This notice replaces all language in Part Q (Office of the Secretary) of the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services (HHS or the Department), Office of Inspector General (OIG) (81 FR 13807, as published March 15, 2016). The Statement of Organization, Functions, and Delegations of Authority conforms to and carries out the statutory requirements for operating OIG. The organizational changes reflected in this notice are primarily to realign the functions within OIG to better reflect the current work environment and priorities and to more clearly delineate responsibilities for the various activities within OIG's offices. OIG was established by law as an independent and objective oversight unit of the Department to carry out the mission of preventing fraud and abuse and promoting economy, efficiency, and effectiveness of HHS programs and operations. In furtherance of this mission, the organization: Conducts and supervises audits, investigations, evaluations, and inspections relating to HHS programs and operations; identifies systemic weaknesses giving rise to opportunities for fraud and abuse in HHS programs and operations and makes recommendations to prevent their recurrence; leads and coordinates activities to prevent and detect fraud and abuse in HHS programs and operations; detects wrongdoers and abusers of HHS programs and beneficiaries so appropriate remedies may be brought to bear, including imposing administrative sanctions against providers of health care under Medicare and Medicaid who commit certain prohibited acts; and keeps the Secretary of Health and Human Services and Congress fully and currently informed about problems and deficiencies in the administration of HHS programs and operations and about the need for and progress of corrective action. In addition, OIG works with the Department of Justice (DOJ), on behalf of the Secretary, to operate the Health Care Fraud and Abuse Control Program. In accordance with authority enacted in its annual appropriations, OIG also provides protection services to the Secretary and conducts criminal investigations of violations of Federal child support provisions. In support of its mission, OIG carries out and maintains an internal quality assurance system and a peer-review system with other Offices of Inspector General, including periodic quality assessment studies and quality control reviews, to provide reasonable assurance that applicable laws, regulations, policies, procedures, standards, and other requirements are followed, are effective, and are functioning as intended in OIG operations. Section Q, Office of Inspector GeneralOrganization
Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP
Document Number: 2018-18519
Type: Proposed Rule
Date: 2018-08-27
Agency: Department of Health and Human Services, Office of Inspector General
This request for information seeks input from the public on how to address any regulatory provisions that may act as barriers to coordinated care or value-based care.
Solicitation of New Safe Harbors and Special Fraud Alerts
Document Number: 2017-27117
Type: Proposed Rule
Date: 2017-12-27
Agency: Department of Health and Human Services, Office of Inspector General
In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notification solicits proposals and recommendations for developing new, and modifying existing, safe harbor provisions under the Federal anti- kickback statute (Sec. 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.
Privacy Act of 1974; System of Records
Document Number: 2017-01412
Type: Notice
Date: 2017-01-23
Agency: Department of Agriculture, Office of Inspector General
In accordance with the Privacy Act, the United States Department of Agriculture, Office of Inspector General (USDA OIG) publishes this records notice to modify an existing system of records, USDA/OIG-8, the Research Aggregated Data Analysis Repository (RADAR) System, in order to update certain system information, including the system owner, and to clarify the records contained in the system and the purpose of the system.
Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Exclusion Authorities
Document Number: 2016-31390
Type: Rule
Date: 2017-01-12
Agency: Department of Health and Human Services, Office of Inspector General
This final rule amends the regulations relating to exclusion authorities under the authority of the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS or the Department). The final rule incorporates statutory changes, early reinstatement provisions, and policy changes, and clarifies existing regulatory provisions.
Solicitation of New Safe Harbors and Special Fraud Alerts
Document Number: 2016-31170
Type: Proposed Rule
Date: 2016-12-28
Agency: Department of Health and Human Services, Office of Inspector General
In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notice solicits proposals and recommendations for developing new, and modifying existing, safe harbor provisions under the Federal anti- kickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.
Announcement of Updated Requirements and Registration for “The Simple Extensible Sampling Tool Challenge”
Document Number: 2016-31182
Type: Notice
Date: 2016-12-27
Agency: Department of Health and Human Services, Office of Inspector General
On September 29, 2016, OIG announced ``The Simple Extensible Sampling Tool Challenge''. This notice serves as an update to the original notice which stated that upon receipt of an updated submission the previous submission would be excluded in its entirety from the competition. This updated notice removes this restriction for entries from teams that have been previously identified as finalists. Any finalist may update their entry without losing their finalist designation. Updates from the finalists will be accepted until 5:00 p.m. EST on the fourteenth day after the fifth finalist has been identified or May 15, 2017, 5:00 p.m. EST, whichever comes first. The newest entry from each team will be used for all judging purposes unless otherwise requested by the team. Other than the above change, all rules and requirements outlined in the September 29, 2016, Federal Register notice remain in effect.
Organization, Functions, and Delegations of Authority
Document Number: 2016-29976
Type: Rule
Date: 2016-12-21
Agency: Department of Agriculture, Office of Inspector General
The U.S. Department of Agriculture (USDA), Office of Inspector General (OIG) amends its regulation relating to organization, functions, and delegations of authority. The amendments are necessary to reflect reorganizations within OIG.
Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements
Document Number: 2016-28297
Type: Rule
Date: 2016-12-07
Agency: Department of Health and Human Services, Office of Inspector General
In this final rule, OIG amends the safe harbors to the anti- kickback statute by adding new safe harbors that protect certain payment practices and business arrangements from sanctions under the anti-kickback statute. The OIG also amends the civil monetary penalty (CMP) rules by codifying revisions to the definition of ``remuneration,'' added by the Balanced Budget Act (BBA) of 1997 and the Patient Protection and Affordable Care Act, Public Law 111-148, 124 Stat. 119 (2010), as amended by the Health Care and Education Reconciliation Act of 2010 (ACA). This rule updates the existing safe harbor regulations and enhances flexibility for providers and others to engage in health care business arrangements to improve efficiency and access to quality care while protecting programs and patients from fraud and abuse.
Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Civil Monetary Penalty Rules
Document Number: 2016-28293
Type: Rule
Date: 2016-12-07
Agency: Department of Health and Human Services, Office of Inspector General
This final rule amends the civil monetary penalty (CMP or penalty) rules of the Office of Inspector General to incorporate new CMP authorities, clarify existing authorities, and reorganize regulations on civil money penalties, assessments, and exclusions to improve readability and clarity.
Succession, Delegations of Authority, and Signature Authorities, No. IG-1313, Change 8
Document Number: 2016-29096
Type: Notice
Date: 2016-12-05
Agency: Department of Agriculture, Office of Inspector General
On November 9, 2016, USDA Inspector General Phyllis K. Fong, pursuant to authority vested in her by the Federal Vacancies Reform Act (5 U.S.C. 3345-3349d) and the Inspector General Act of 1978, as amended (5 U.S.C. app. 3), issued IG-1313, Change 8, Succession, Delegations of Authority, and Signature Authorities. This directive is a revised succession order and reflects delegations of authority for the Office of Inspector General. This directive has been revised to update the lines of succession and delegation, and to clarify procedures to be followed in the event the Office of Inspector General (OIG) headquarters must be relocated. This directive provides guidance on the transfer of functions and duties of the Inspector General (IG), as well as other OIG central management functions, regardless of what events necessitate such transfer.
Announcement of Requirements and Registration for “The Simple Extensible Sampling Tool Challenge”
Document Number: 2016-23124
Type: Notice
Date: 2016-09-29
Agency: Department of Health and Human Services, Office of Inspector General
The Simple Extensible Sampling Tool Challenge (Challenge) is an HHS/OIG Challenge under the ``America COMPETES'' (Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science) Reauthorization Act of 2010 (Pub. L. 111-358). The objective of this Challenge is to construct a sampling tool to replace the current version of RAT-STATS software.
Medicaid; Revisions to State Medicaid Fraud Control Unit Rules
Document Number: 2016-22269
Type: Proposed Rule
Date: 2016-09-20
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Office of Inspector General
This proposed rule would amend the regulation governing State Medicaid Fraud Control Units (MFCUs or Units). The proposed rule would incorporate statutory changes affecting the MFCUs as well as policy and practice changes that have occurred since the regulation was initially issued in 1978. These changes include a codification of OIG's delegated authority, MFCU authority, functions, and responsibilities; disallowances; and issues related to organization, prosecutorial authority, staffing, recertification, and the MFCUs' relationship with Medicaid agencies.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2016-05714
Type: Notice
Date: 2016-03-15
Agency: Department of Health and Human Services, Office of Inspector General
This notice replaces all language in Part A (Office of the Secretary) of the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services (HHS), Office of Inspector General (OIG) (70 FR 20147, as amended April 18, 2005; as last amended at 73 FR 7568, dated February 8, 2008). The statement of organization, functions, and delegations of authority conforms to and carries out the statutory requirements for operating OIG. The organizational changes reflected in this notice are primarily to realign the functions within OIG to better reflect the current work environment and priorities, and to more clearly delineate responsibilities for the various activities within OIG's offices. In addition, this notice removes all of Chapter A and establishes Chapter Q. OIG was established by law as an independent and objective oversight unit of the Department to carry out the mission of preventing fraud and abuse and promoting economy, efficiency and effectiveness of HHS programs and operations. In furtherance of this mission, the organization: A. Conducts and supervises audits, investigations, evaluations and inspections relating to HHS programs and operations. B. Identifies systemic weaknesses giving rise to opportunities for fraud and abuse in HHS programs and operations and makes recommendations to prevent their recurrence. C. Leads and coordinates activities to prevent and detect fraud and abuse in HHS programs and operations. D. Detects wrongdoers and abusers of HHS programs and beneficiaries so appropriate remedies may be brought to bear, including imposing administrative sanctions against providers of health care under Medicare and Medicaid who commit certain prohibited acts. E. Keeps the Secretary and Congress fully and currently informed about problems and deficiencies in the administration of HHS programs and operations and about the need for and progress of corrective action. In addition, OIG works with the Department of Justice (DOJ), on behalf of the Secretary, to operate the Health Care Fraud and Abuse Control Program. In accordance with authority enacted in its annual appropriations, OIG also provides protection services to the Secretary and conducts criminal investigations of violations of Federal child support provisions. In support of its mission, OIG carries out and maintains an internal quality assurance system and a peer review system with other Offices of Inspectors General, including periodic quality assessment studies and quality control reviews, to provide reasonable assurance that applicable laws, regulations, policies, procedures, standards, and other requirements are followed, are effective, and are functioning as intended in OIG operations.
Solicitation of New Safe Harbors and Special Fraud Alerts
Document Number: 2015-32267
Type: Proposed Rule
Date: 2015-12-23
Agency: Department of Health and Human Services, Office of Inspector General
In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual document solicits proposals and recommendations for developing new, and modifying existing, safe harbor provisions under the Federal anti- kickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.
Medicare Program; Final Waivers in Connection With the Shared Savings Program
Document Number: 2015-27599
Type: Rule
Date: 2015-10-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Office of Inspector General
This final rule finalizes waivers of the application of the physician self-referral law, the Federal anti-kickback statute, and the civil monetary penalties (CMP) law provision relating to beneficiary inducements to specified arrangements involving accountable care organizations (ACOs) under section 1899 of the Social Security Act (the Act) (the ``Shared Savings Program''), as set forth in the Interim Final Rule with comment period (IFC) dated November 2, 2011. As explained in greater detail below, in light of legislative changes that occurred after publication of the IFC, this final rule does not finalize waivers of the application of the CMP law provision relating to ``gainsharing'' arrangements. Section 1899(f) of the Act, as added by the Affordable Care Act, authorizes the Secretary to waive certain fraud and abuse laws as necessary to carry out the provisions of section 1899 of the Act.
Solicitation of New Safe Harbors and Special Fraud Alerts
Document Number: 2014-30156
Type: Proposed Rule
Date: 2014-12-30
Agency: Department of Health and Human Services, Office of Inspector General
In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notice solicits proposals and recommendations for developing new and modifying existing safe harbor provisions under the Federal anti-kickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.
Solicitation of Information and Recommendations for Revising OIG's Non-Binding Criteria for Implementing Permissive Exclusion Authority Under Section 1128(b)(7) of the Social Security Act
Document Number: 2014-25681
Type: Notice
Date: 2014-10-29
Agency: Department of Health and Human Services, Office of Inspector General
This document announces an extension of the public comment period for the OIG Federal Register notice published on July 11, 2014 (79 FR 40114). The notice solicited input from the public on revising the criteria used by OIG in implementing its permissive exclusion authority under Section 1128(b)(7) of the Social Security Act. Due to a technical problem, the public may have been unable to submit comments at http://www.regulations.gov during the comment period. Accordingly, we are extending the comment period to ensure that the public has an opportunity to provide input.
Medicare Program; Final Waivers in Connection With the Shared Savings Program; Continuation of Effectiveness and Extension of Timeline for Publication of Final Rule
Document Number: 2014-24663
Type: Rule
Date: 2014-10-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Office of Inspector General
This document announces the continuation of effectiveness of an interim final rule and the extension of the timeline for publication of the final rule. This document is issued in accordance with section 1871(a)(3)(C) of the Social Security Act (the Act), which allows an interim final rule to remain in effect after the expiration of the timeline specified in section 1871(a)(3)(B) of the Act if the Secretary publishes a notice of continuation prior to the expiration of the timeline.
Medicare and State Health Care Programs: Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements and Gainsharing
Document Number: 2014-23182
Type: Proposed Rule
Date: 2014-10-03
Agency: Department of Health and Human Services, Office of Inspector General
This proposed rule would amend the safe harbors to the anti- kickback statute and the civil monetary penalty (CMP) rules under the authority of the Office of Inspector General (OIG). The proposed rule would add new safe harbors, some of which codify statutory changes set forth in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and the Patient Protection and Affordable Care Act, Public Law 111-148, 124 Stat. 119 (2010), as amended by the Health Care and Education Reconciliation Act of 2010, Public Law 111-152, 124 Stat. 1029 (2010) (ACA), and all of which would protect certain payment practices and business arrangements from criminal prosecution or civil sanctions under the anti-kickback statute. We also propose to codify revisions to the definition of ``remuneration,'' added by the Balanced Budget Act (BBA) of 1997 and ACA, and add a gainsharing CMP provision in our regulations.
Solicitation of Information and Recommendations for Revising OIG's Non-Binding Criteria for Implementing Permissive Exclusion Authority Under Section 1128(b)(7) of the Social Security Act
Document Number: 2014-16222
Type: Notice
Date: 2014-07-11
Agency: Department of Health and Human Services, Office of Inspector General
This Federal Register notice informs the public that OIG: (1) Is considering revising the Non-Binding Criteria for Implementing Permissive Exclusion Authority Under Section 1128(b)(7) of the Social Security Act (62 FR 67392, December 24, 1997), and (2) is soliciting input from the public for OIG to consider in developing the revised criteria.
Special Fraud Alert: Laboratory Payments to Referring Physicians
Document Number: 2014-16219
Type: Notice
Date: 2014-07-11
Agency: Department of Health and Human Services, Office of Inspector General
This Special Fraud Alert addresses compensation paid by laboratories to referring physicians and physician group practices (collectively, physicians) for blood specimen collection, processing, and packaging, and for submitting patient data to a registry or database. OIG has issued a number of guidance documents and advisory opinions addressing the general subject of remuneration offered and paid by laboratories to referring physicians, including the 1994 Special Fraud Alert on Arrangements for the Provision of Clinical Laboratory Services, the OIG Compliance Program Guidance for Clinical Laboratories, and Advisory Opinion 05-08. In these and other documents, we have repeatedly emphasized that providing free or below-market goods or services to a physician who is a source of referrals, or paying such a physician more than fair market value for his or her services, could constitute illegal remuneration under the anti-kickback statute. This Special Fraud Alert supplements these prior guidance documents and advisory opinions and describes two specific trends OIG has identified involving transfers of value from laboratories to physicians that we believe present a substantial risk of fraud and abuse under the anti- kickback statute.
Supplemental Special Advisory Bulletin: Independent Charity Patient Assistance Programs
Document Number: 2014-11769
Type: Notice
Date: 2014-05-30
Agency: Department of Health and Human Services, Office of Inspector General
This Supplemental Bulletin updates the OIG Special Advisory Bulletin on Patient Assistance Programs for Medicare Part D Enrollees that published in the Federal Register on November 22, 2005 (70 FR 70623).
Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Civil Monetary Penalty Rules
Document Number: 2014-10394
Type: Proposed Rule
Date: 2014-05-12
Agency: Department of Health and Human Services, Office of Inspector General
This proposed rule would amend the civil monetary penalty (CMP or penalty) rules of the Office of Inspector General (OIG) to incorporate new CMP authorities, clarify existing authorities, and reorganize regulations on civil money penalties, assessments and exclusions to improve readability and clarity.
Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Exclusion Authorities
Document Number: 2014-10390
Type: Proposed Rule
Date: 2014-05-09
Agency: Department of Health and Human Services, Office of Inspector General
This proposed rule amends the regulations relating to exclusion authorities under the authority of the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS or the Department). The proposed rule would incorporate statutory changes, propose early reinstatement procedures, and clarify existing regulatory provisions.
Medicare and State Health Care Programs: Fraud and Abuse; Electronic Health Records Safe Harbor Under the Anti-Kickback Statute
Document Number: 2013-30924
Type: Rule
Date: 2013-12-27
Agency: Department of Health and Human Services, Office of Inspector General
In this final rule, the Office of Inspector General (OIG) amends the safe harbor regulation concerning electronic health records items and services, which defines certain conduct that is protected from liability under the Federal anti-kickback statute, section 1128B(b) of the Social Security Act (the Act). Amendments include updating the provision under which electronic health records software is deemed interoperable; removing the electronic prescribing capability requirement; extending the sunset provision until December 31, 2021; limiting the scope of protected donors to exclude laboratory companies; and clarifying the condition that prohibits a donor from taking any action to limit or restrict the use, compatibility, or interoperability of the donated items or services.
Solicitation of New Safe Harbors and Special Fraud Alerts
Document Number: 2013-30429
Type: Proposed Rule
Date: 2013-12-27
Agency: Department of Health and Human Services, Office of Inspector General
In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notice solicits proposals and recommendations for developing new and modifying existing safe harbor provisions under the Federal anti-kickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.
Statement of Delegation of Authority
Document Number: 2013-30160
Type: Notice
Date: 2013-12-19
Agency: Department of Health and Human Services, Office of Inspector General
State Medicaid Fraud Control Units; Data Mining
Document Number: 2013-11735
Type: Rule
Date: 2013-05-17
Agency: Department of Health and Human Services, Office of Inspector General
This final rule amends a provision in HHS regulations prohibiting State Medicaid Fraud Control Units (MFCU) from using Federal matching funds to identify fraud through screening and analyzing State Medicaid data, known as data mining. To support and modernize MFCU efforts to effectively pursue Medicaid provider fraud, we finalize proposals to permit Federal financial participation (FFP) in costs of defined data mining activities under specified circumstances. In addition, we finalize requirements that MFCUs annually report costs and results of approved data mining activities to OIG.
Revised OIG's Provider Self-Disclosure Protocol
Document Number: 2013-11050
Type: Notice
Date: 2013-05-10
Agency: Department of Health and Human Services, Office of Inspector General
This notice announces the issuance of the updated Provider Self-Disclosure Protocol (the SDP), originally published in the Federal Register on October 30, 1998 (63 FR 58399). In 1998, the Office of Inspector General published the SDP to establish a process for health care providers to voluntarily identify, disclose, and resolve instances of potential fraud involving the Federal health care programs (as defined in section 1128B(f) of the Social Security Act (the Act), 42 U.S.C. 1320a-7b(f)). The SDP provides guidance on how to investigate this conduct, quantify damages, and report the conduct to OIG to resolve the provider's liability under OIG's civil monetary penalty (CMP) authorities. Since the original publication, we identified areas where additional guidance would be beneficial to the health care community and would improve the efficient resolution of SDP matters. To that end, we issued three Open Letters to Health Care Providers in 2006, 2008, and 2009. Since the last Open Letter, we continued to evaluate our SDP process. We also solicited comments about the SDP on June 18, 2012, and we received numerous helpful comments from the public. On the basis of our experience and the comments we received, we have decided to revise the SDP in its entirety at this time. This revised SDP supersedes and replaces the 1998 Federal Register Notice and the Open Letters. OIG has posted the full revision of the SDP on its Web site: http:/ /oig.hhs.gov/compliance/self-disclosure-info/index.asp.
Updated Special Advisory Bulletin on the Effect of Exclusion From Participation in Federal Health Care Programs
Document Number: 2013-11055
Type: Notice
Date: 2013-05-09
Agency: Department of Health and Human Services, Office of Inspector General
This notice announces the release of an updated Special Advisory Bulletin on the effect of exclusion from participation in Federal health care programs by OIG. The updated Special Advisory Bulletin describes the scope and effect of the legal prohibition on payment by Federal health care programs for items or services furnished (1) by an excluded person or (2) at the medical direction or on the prescription of an excluded person. For purposes of OIG exclusion, payment by a Federal health care program includes amounts based on a cost report, fee schedule, prospective payment system, capitated rate, or other payment methodology. The updated Bulletin describes how exclusions can be violated and the administrative sanctions OIG can pursue against those who have violated an exclusion. The updated Bulletin also provides guidance to the health care industry on the scope and frequency of screening employees and contractors to determine whether they are excluded persons. OIG has posted the full revision of the Special Advisory Bulletin on its Web site: http://oig.hhs.gov/exclusions/advisories.asp.
Special Fraud Alert: Physician-Owned Entities
Document Number: 2013-08749
Type: Notice
Date: 2013-04-15
Agency: Department of Health and Human Services, Office of Inspector General
This document sets forth a correction to the OIG Federal Register notice published on March 29, 2012 (78 FR 19271), on our recently issued Special Fraud Alert on Physician-Owned Entities. Specifically, the Special Fraud Alert addressed physician-owned entities that derive revenue from selling, or arranging for the sale of, implantable medical devices ordered by their physician-owners for use in procedures the physician-owners perform on their own patients at hospitals or ambulatory surgical centers. An inadvertent error appeared in the DATES caption of that document regarding the effective date. Accordingly, we are removing the language regarding the effective date to ensure technical correctness of the document.
Medicare and State Health Care Programs: Fraud and Abuse; Electronic Health Records Safe Harbor Under the Anti-Kickback Statute
Document Number: 2013-08314
Type: Proposed Rule
Date: 2013-04-10
Agency: Department of Health and Human Services, Office of Inspector General
In this proposed rule, the Office of Inspector General (OIG) proposes to amend the safe harbor regulation concerning electronic health records items and services, which defines certain conduct that is protected from liability under the Federal anti-kickback statute in the Social Security Act (the Act). The proposed amendments include an update to the provision under which electronic health records software is deemed interoperable; removal of the electronic prescribing capability requirement; and extension of the sunset provision. In addition, OIG is requesting public comment on other changes it is considering.
Special Fraud Alert: Physician-Owned Entities
Document Number: 2013-07394
Type: Notice
Date: 2013-03-29
Agency: Department of Health and Human Services, Office of Inspector General
This Special Fraud Alert addresses physician-owned entities that derive revenue from selling, or arranging for the sale of, implantable medical devices ordered by their physician-owners for use in procedures the physician-owners perform on their own patients at hospitals or ambulatory surgical centers (ASCs).
Solicitation of New Safe Harbors and Special Fraud Alerts
Document Number: 2012-31107
Type: Proposed Rule
Date: 2012-12-28
Agency: Department of Health and Human Services, Office of Inspector General
In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notice solicits proposals and recommendations for developing new and modifying existing safe harbor provisions under the Federal anti-kickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.
Solicitation of Information and Recommendations for Revising OIG's Provider Self-Disclosure Protocol
Document Number: 2012-14585
Type: Notice
Date: 2012-06-18
Agency: Department of Health and Human Services, Office of Inspector General
This Federal Register notice informs the public that OIG: (1) Intends to update the Provider Self-Disclosure Protocol (63 FR 58399, October 30, 1998) and (2) solicits input from the public for OIG to consider in updating the Protocol.
Privacy Act; System of Records
Document Number: 2011-33346
Type: Notice
Date: 2011-12-29
Agency: Department of Health and Human Services, Office of Inspector General
In accordance with the Privacy Act of 1974, as amended, the Office of Inspector General gives notice of a proposed amendment to its Privacy Act system of records entitled ``Consolidated Data Repository'' (09-90-1000). This system of records is being amended to include records regarding Federal and State benefit programs and service providers in Federal health care programs.
Solicitation of New Safe Harbors and Special Fraud Alerts
Document Number: 2011-33345
Type: Proposed Rule
Date: 2011-12-29
Agency: Department of Health and Human Services, Office of Inspector General
In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notice solicits proposals and recommendations for developing new and modifying existing safe harbor provisions under the Federal anti-kickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.
Medicare Program; Final Waivers in Connection With the Shared Savings Program
Document Number: 2011-27460
Type: Rule
Date: 2011-11-02
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Office of Inspector General
This interim final rule with comment period establishes waivers of the application of the Physician Self-Referral Law, the Federal anti-kickback statute, and certain civil monetary penalties (CMP) law provisions to specified arrangements involving accountable care organizations (ACOs) under section 1899 of the Social Security Act (the Act) (the Shared Savings Program), including ACOs participating in the Advance Payment Initiative. Section 1899(f) of the Act, as added by the Affordable Care Act, authorizes the Secretary to waive certain fraud and abuse laws as necessary to carry out the provisions of section 1899 of the Act.
Proposed Revision of Performance Standards for State Medicaid Fraud Control Units
Document Number: 2011-25894
Type: Notice
Date: 2011-10-06
Agency: Department of Health and Human Services, Office of Inspector General, Inspector General Office, Health and Human Services Department, Centers for Medicare & Medicaid Services
This notice seeks comment on an OIG proposal to revise standards for assessing the performance of the State Medicaid Fraud Control Units (MFCUs or Units). This proposal would replace and supersede standards published on September 26, 1994 (59 FR 49080).
State Medicaid Fraud Control Units; Data Mining
Document Number: 2011-6012
Type: Proposed Rule
Date: 2011-03-17
Agency: Department of Health and Human Services, Office of Inspector General
This proposed rule amends a provision in HHS regulations that prohibits State Medicaid Fraud Control Units (MFCU) from using Federal matching funds to identify fraud through screening and analyzing State Medicaid claims data, known as data mining. To support and modernize MFCU efforts to effectively pursue Medicaid provider fraud, we propose to permit Federal Financial Participation (FFP) in the costs of defined data mining activities under specified conditions. In addition, we propose that MFCUs annually report the costs and results of approved data mining activities to OIG.