42 CFR 1001.101 - Basis for liability.
The OIG will exclude any individual or entity that -
(a) Has been convicted of a criminal offense related to the delivery of an item or service under Medicare or a State health care program, including the performance of management or administrative services relating to the delivery of items or services under any such program;
(b) Has been convicted, under Federal or State law, of a criminal offense related to the neglect or abuse of a patient, in connection with the delivery of a health care item or service, including any offense that the OIG concludes entailed, or resulted in, neglect or abuse of patients (the delivery of a health care item or service includes the provision of any item or service to an individual to meet his or her physical, mental or emotional needs or well-being, whether or not reimbursed under Medicare, Medicaid or any Federal health care program);
(c) Has been convicted, under Federal or State law, of a felony that occurred after August 21, 1996, relating to fraud, theft, embezzlement, breach of fiduciary responsibility, or other financial misconduct -
(1) In connection with the delivery of a health care item or service, including the performance of management or administrative services relating to the delivery of such items or services, or
(2) With respect to any act or omission in a health care program (other than Medicare and a State health care program) operated by, or financed in whole or in part, by any Federal, State or local government agency; or
(d) Has been convicted, under Federal or State law, of a felony that occurred after August 21, 1996 relating to the unlawful manufacture, distribution, prescription or dispensing of a controlled substance, as defined under Federal or State law. This applies to any individual or entity that -
(1) Is, or has ever been, a health care practitioner, provider, or supplier or furnished or furnishes items or services;
(2) Holds, or has held, a direct or an indirect ownership or control interest in an entity that furnished or furnishes items or services or is, or has ever been, an officer, director, agent, or managing employee of such an entity; or
(3) Is, or has ever been, employed in any capacity in the health care industry.
Title 42 published on 06-Feb-2018 04:05
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 42 CFR Part 1001 after this date.
GPO FDSys XML | Text type regulations.gov FR Doc. 2017-27117 RIN DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of Inspector General Notification of intent to develop regulations. To ensure consideration, public comments must be delivered to the address provided below by no later than 5 p.m. on February 26, 2018. 42 CFR Part 1001 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 (§ 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.
GPO FDSys XML | Text type regulations.gov FR Doc. 2016-31390 RIN DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of Inspector General Final rule. These regulations are effective on February 13, 2017. 42 CFR Parts 1000, 1001, 1002, and 1006 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.
GPO FDSys XML | Text type regulations.gov FR Doc. 2016-31170 RIN DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of Inspector General Notice of intent to develop regulations. To ensure consideration, public comments must be delivered to the address provided below by no later than 5 p.m. on February 27, 2017. 42 CFR Part 1001 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.
GPO FDSys XML | Text type regulations.gov FR Doc. 2016-28297 RIN 0936-AA06 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of Inspector General Final rule. These regulations are effective on January 6, 2017. 42 CFR Parts 1001 and 1003 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.
GPO FDSys XML | Text type regulations.gov FR Doc. 2015-32267 RIN DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of Inspector General Notice of intent to develop regulations. To ensure consideration, public comments must be delivered to the address provided below by no later than 5 p.m. on February 22, 2016. 42 CFR Part 1001 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.
GPO FDSys XML | Text type regulations.gov FR Doc. 2014-30156 RIN DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of Inspector General Notice of intent to develop regulations. To ensure consideration, public comments must be delivered to the address provided below by no later than 5 p.m. on March 2, 2015. 42 CFR Part 1001 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.
GPO FDSys XML | Text type regulations.gov FR Doc. 2014-23182 RIN 0936-AA06 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of Inspector General Proposed rule. To ensure consideration, comments must be delivered to the address provided below by no later than 5 p.m. Eastern Standard Time on December 2, 2014. 42 CFR Parts 1001 and 1003 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.
GPO FDSys XML | Text type regulations.gov FR Doc. 2014-10390 RIN 0936-AA05 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of Inspector General Proposed rule. To ensure consideration, comments must be delivered to the address provided below by no later than 5 p.m. Eastern Standard Time on July 8, 2014. 42 CFR Parts 1000, 1001, 1002, and 1006 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.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-30429 RIN DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of Inspector General Notice of intent to develop regulations. To ensure consideration, public comments must be delivered to the address provided below by no later than 5 p.m. on February 25, 2014. 42 CFR Part 1001 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.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-30924 RIN 0991-AB33 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of Inspector General Final rule. Effective Date: With the exception of the revision of 42 CFR 1001.952(y)(13), this regulation is effective on March 27, 2014. The revision of 42 CFR 1001.952(y)(13) is effective on December 31, 2013. 42 CFR Part 1001 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.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-08314 RIN 0936-AA03 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of Inspector General Proposed rule. To assure consideration, comments must be delivered to the address provided below by no later than 5 p.m. Eastern Standard Time on June 10, 2013. 42 CFR Part 1001 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.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-31107 RIN DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of Inspector General Notice of intent to develop regulations. To ensure consideration, public comments must be delivered to the address provided below by no later than 5 p.m. on February 26, 2013. 42 CFR Part 1001 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.
- 42 CFR 1001.2006 — Notice to Others Regarding Exclusion.
- 42 CFR 1001.102 — Length of Exclusion.
- 42 CFR 1001.1801 — Waivers of Exclusions.
- 42 CFR 1001.301 — Conviction Relating to Obstruction of an Investigation or Audit.
- 42 CFR 1001.1551 — Exclusion of Individuals With Ownership or Control Interest in Sanctioned Entities.