Solicitation of New Safe Harbors and Special Fraud Alerts
In accordance with section 205 of the Health Insurance Portability and Accountability Act (HIPAA) of 1996, 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.
Draft OIG Compliance Program Guidance for Recipients of PHS Research Awards-Extension of Comment Period
On November 28, 2005, we published a notice and comment period seeking comments from interested parties on draft compliance program guidance (CPG) developed by the Office of Inspector General (OIG) for recipients of extramural research awards from the National Institutes of Health and other agencies of the U.S. Public Health Service (PHS) (70 FR 71312). To facilitate public comment, we are extending the comment period.
Draft OIG Compliance Program Guidance for Recipients of PHS Research Awards
This Federal Register notice seeks the comments of interested parties on draft compliance guidance developed by the Office of Inspector General (OIG) for recipients of extramural research awards from the National Institutes of Health (NIH) and other agencies of the U.S. Public Health Service (PHS). Through this notice, OIG is setting forth its general views on the value and fundamental principles of compliance programs for colleges and universities and other recipients of PHS awards for biomedical and behavioral research and the specific elements that these award recipients should consider when developing and implementing an effective compliance program.
Publication of OIG Special Advisory Bulletin on Patient Assistance Programs for Medicare Part D Enrollees
OIG periodically develops and issues guidance, including Special Advisory Bulletins, to alert and inform the health care industry about potential problems or areas of special interest. This Federal Register notice sets forth the recently issued OIG Special Advisory Bulletin addressing patient assistance programs for Medicare Part D enrollees.
Privacy Act of 1974: Implementation of Exemptions
The Department of Homeland Security is giving notice of a revised and updated system of records pursuant to the Privacy Act of 1974 for the Office of Inspector General, Office of Investigations. In this proposed rulemaking, the Department proposes to exempt portions of this system of records from one or more provisions of the Privacy Act because of criminal, civil and administrative enforcement requirements.
Medicare and State Health Care Programs: Fraud and Abuse; Safe Harbor for Certain Electronic Prescribing Arrangements Under the Anti-Kickback Statute
As required by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), Public Law 108-173, this proposed rule would establish a new safe harbor under the Federal anti-kickback statute for certain arrangements involving the provision of electronic prescribing technology. Specifically, the safe harbor would protect certain arrangements involving hospitals, group practices, and prescription drug plan (PDP) sponsors and Medicare Advantage (MA) organizations that provide to specified recipients certain nonmonetary remuneration in the form of hardware, software, or information technology and training services necessary and used solely to receive and transmit electronic prescription drug information. In addition, using our separate legal authority under section 1128B(b)(3)(E) of the Social Security Act (the ``Act''), we are also proposing separate safe harbor protection for certain electronic health records software and directly related training services. These exceptions are consistent with the President's goal of achieving widespread adoption of interoperable electronic health records for the purpose of improving the quality and efficiency of health care, while maintaining the levels of security and privacy that consumers expect.
Health Care Fraud and Abuse Data Collection Program: Reporting of Final Adverse Actions; Correction
This document corrects the final regulations establishing the Healthcare Integrity and Protection Data Bank (HIPDB), the national health care fraud and abuse data collection program for the reporting and disclosing of certain adverse actions taken against health care providers, suppliers and practitioners and for maintaining a data base of final adverse actions taken against health care providers, suppliers and practitioners. In the implementing HIPDB regulations published in the Federal Register on October 26, 1999 (64 FR 57740), an inadvertent error appeared in the regulations text concerning the definition of the term ``any other negative action or finding.'' As a result, we are correcting the definition of the term to assure the technical correctness of these regulations.
Medicare and State Health Care Programs: Fraud and Abuse; Safe Harbor for Federally Qualified Health Centers Under the Anti-Kickback Statute
In accordance with section 431 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), Public Law 108- 173, this proposed rule would establish regulatory standards for the new safe harbor under the Federal anti-kickback statute for certain goods, items, services, donations, and loans provided by individuals and entities to certain health centers funded under section 330 of the Public Health Service Act. Under this proposed safe harbor, the goods, items, services, donations, or loans must contribute to the health center's ability to maintain or increase the availability, or enhance the quality, of services available to a medically underserved population.
Office of the Secretary, Health Care Fraud and Abuse Data Collection Program: Reporting of Final Adverse Actions; Correction
This document proposes a correction to the final regulations, which were published in the Federal Register on October 26, 1999 (64 FR 57740). These regulations established a national health care fraud and abuse data collection program for the reporting and disclosing of certain adverse actions taken against health care providers, suppliers and practitioners, and for maintaining a data base of final adverse actions taken against health care providers, suppliers and practitioners. An inadvertent error appeared in the text of the regulations concerning the definition of the term ``any other negative action or finding.'' As a result, we are proposing to correct 45 CFR 61.3, Definitions, to assure the technical correctness of these regulations.
Succession and Delegations of Authority
On July 19, 2004, 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 (5 U.S.C. App. 3), issued IG-1313, Change 6, Succession and Delegations of Authority. This directive is a revised Succession and Delegations of Authority for the Office of Inspector General. This directive has been revised to show the lines of succession and delegation and clarifies 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.
Possession, Use, and Transfer of Select Agents and Toxins
This document establishes a final rule regarding possession, use, and transfer of select agents and toxins. The final rule implements provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and is designed to protect public health and safety. In a companion document published in this issue of the Federal Register, the United States Department of Agriculture has established corresponding final rules designed to protect animal and plant health and animal and plant products.
OIG Supplemental Compliance Program Guidance for Hospitals
This Federal Register notice sets forth the Supplemental Compliance Program Guidance (CPG) for Hospitals developed by the Office of Inspector General (OIG). Through this notice, the OIG is supplementing its prior compliance program guidance for hospitals issued in 1998. The supplemental CPG contains new compliance recommendations and an expanded discussion of risk areas, taking into account recent changes to hospital payment systems and regulations, evolving industry practices, current enforcement priorities, and lessons learned in the area of corporate compliance. The supplemental CPG provides voluntary guidelines to assist hospitals and hospital systems in identifying significant risk areas and in evaluating and, as necessary, refining ongoing compliance efforts.