42 CFR 1001.101 - Basis for liability.

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§ 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.

[ 63 FR 46686, Sept. 2, 1998, as amended at 67 FR 11932, Mar. 18, 2002; 82 FR 4112, Jan. 12, 2017]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code

U.S. Code: Title 31 - MONEY AND FINANCE

§ 6101 note - Definitions

U.S. Code: Title 42 - THE PUBLIC HEALTH AND WELFARE

§ 1302 - Rules and regulations; impact analyses of Medicare and Medicaid rules and regulations on small rural hospitals

§ 1320a-7

§ 1320a-7b

§ 1395u - Provisions relating to the administration of part B

§ 1395w-104

§ 1395y - Exclusions from coverage and medicare as secondary payer

§ 1395cc - Agreements with providers of services; enrollment processes

§ 1395hh - Regulations

Title 42 published on 18-Aug-2017 04:51

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 42 CFR Part 1001 after this date.

2017-01-12; vol. 82 # 8 - Thursday, January 12, 2017

82 FR 4100 - Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Exclusion Authorities

GPO FDSys XML | Text

Additional Documents

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

Summary

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.

2016-12-28; vol. 81 # 249 - Wednesday, December 28, 2016

81 FR 95551 - Solicitation of New Safe Harbors and Special Fraud Alerts

GPO FDSys XML | Text

Additional Documents

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

Summary

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.

2016-12-07; vol. 81 # 235 - Wednesday, December 7, 2016

81 FR 88368 - 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

GPO FDSys XML | Text

Additional Documents

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

Summary

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.

2015-12-23; vol. 80 # 246 - Wednesday, December 23, 2015

80 FR 79803 - Solicitation of New Safe Harbors and Special Fraud Alerts

GPO FDSys XML | Text

Additional Documents

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

Summary

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.

2014-12-30; vol. 79 # 249 - Tuesday, December 30, 2014

79 FR 78376 - Solicitation of New Safe Harbors and Special Fraud Alerts

GPO FDSys XML | Text

Additional Documents

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

Summary

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.

2014-10-03; vol. 79 # 192 - Friday, October 3, 2014

79 FR 59717 - 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

GPO FDSys XML | Text

Additional Documents

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

Summary

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.

2014-05-09; vol. 79 # 90 - Friday, May 9, 2014

79 FR 26810 - Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Exclusion Authorities

GPO FDSys XML | Text

Additional Documents

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

Summary

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.

2013-12-27; vol. 78 # 249 - Friday, December 27, 2013

78 FR 78807 - Solicitation of New Safe Harbors and Special Fraud Alerts

GPO FDSys XML | Text

Additional Documents

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

Summary

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.

78 FR 79202 - Medicare and State Health Care Programs: Fraud and Abuse; Electronic Health Records Safe Harbor Under the Anti-Kickback Statute

GPO FDSys XML | Text

Additional Documents

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

Summary

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.

2013-04-10; vol. 78 # 69 - Wednesday, April 10, 2013

78 FR 21314 - Medicare and State Health Care Programs: Fraud and Abuse; Electronic Health Records Safe Harbor Under the Anti-Kickback Statute

GPO FDSys XML | Text

Additional Documents

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

Summary

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.

2012-12-28; vol. 77 # 249 - Friday, December 28, 2012

77 FR 76434 - Solicitation of New Safe Harbors and Special Fraud Alerts

GPO FDSys XML | Text

Additional Documents

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

Summary

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.

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