Inspector General Office, Health and Human Services Department – Federal Register Recent Federal Regulation Documents
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Proposed Revision of Performance Standards for State Medicaid Fraud Control Units
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).
Solicitation of New Safe Harbors and Special Fraud Alerts
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.
Privacy Act of 1974; System of Records
The Office of Inspector General (OIG) is deleting from its existing inventory of record systems subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended.
Solicitation of Information and Recommendations for Supplementing the Guidance Provided in the Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs
This notice informs the public that the Office of Inspector General (OIG) intends to update the Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs (64 FR 52791; September 30, 1999) and solicits input from the public for OIG to consider in developing the updated bulletin.
Publication of OIG Updated Special Fraud Alert on Telemarketing by Durable Medical Equipment Suppliers
This document sets forth a correction to the OIG Federal
Publication of OIG Updated Special Fraud Alert on Telemarketing by Durable Medical Equipment Suppliers
This Federal Register notice sets forth the recently issued
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.
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.
Privacy Act of 1974; New OIG Privacy Act System of Records: Consolidated Data Repository
The Privacy Act of 1974 (5 U.S.C. 552(e)(4)) requires that all agencies publish in the Federal Register a notice of the existence and character of their system of records. Notice is hereby given that OIG is adding a new system of records entitled ``Consolidated Data RepositoryHHS-OIG'' (09-90-1000).
OIG Supplemental Compliance Program Guidance for Nursing Facilities
This Federal Register notice sets forth the supplemental compliance program guidance (CPG) for nursing facilities developed by the Office of Inspector General (OIG). OIG is supplementing its prior CPG for nursing facilities issued in 2000. The supplemental CPG contains new compliance recommendations and an expanded discussion of risk areas. The supplemental CPG takes into account Medicare and Medicaid nursing facility payment systems and regulations, evolving industry practices, current enforcement priorities (including the Government's heightened focus on quality of care), and lessons learned in the area of nursing facility compliance. The supplemental CPG provides voluntary guidelines to assist nursing facilities in identifying significant risk areas and in evaluating and, as necessary, refining ongoing compliance efforts.
Office of Inspector General; Medicare and State Health Care Programs: Fraud and Abuse; Issuance of Advisory Opinions by the OIG
OIG is adopting in final form, without change, an interim final rule published on March 26, 2008 (73 FR 15937). We received no comments to the interim final rule. The interim final rule revised the process for advisory opinion requestors to submit payments for advisory opinion costs.
Draft OIG Supplemental Compliance Program Guidance for Nursing Facilities
This Federal Register proposed notice seeks the comments of interested parties on a draft supplemental compliance program guidance (CPG) for nursing facilities developed by the Office of Inspector General (OIG). When OIG publishes the final version of this guidance, it will supplement OIG's prior CPG for nursing facilities issued in 2000. This proposed notice contains new compliance recommendations and an expanded discussion of risk areas. The proposed notice takes into account Medicare and Medicaid nursing facility payment systems and regulations, evolving industry practices, current enforcement priorities (including the Government's heightened focus on quality of care), and lessons learned in the area of nursing facility compliance. When published, the final supplemental CPG will provide voluntary guidelines to assist nursing facilities in identifying significant risk areas and in evaluating and, as necessary, refining ongoing compliance efforts.
Privacy Act of 1974, New OIG Privacy Act System of Records: Litigation Files
The Office of Inspector General (OIG) is proposing a new system of records, entitled Litigation Files, Administrative Complaints, and Personnel Actions, HHS/OS/OIG/OCIG (09-90-0077). This proposed notice is in accordance with the Privacy Act requirement that agencies publish their systems of records in the Federal Register when there is a revision, change, or addition. This new system will replicate the existing system of records, entitled Litigation Files, Administrative Complaints, and Adverse Personnel Actions, HHS/OS/OGC (09-90-0064), to reflect that responsibility for providing legal services to the Inspector General has transferred to OIG's Office of Counsel to the Inspector General (OCIG). The existing Litigation Files system of records (09-90-0064) remains with the Department's Office of General Counsel and will be unchanged. This notice specifically covers that portion of the records that transferred to, or have been since created and maintained by, OCIG. The Litigation Files, Administrative Complaints, and Personnel Actions, HHS/OS/OIG/ OCIG system of records will be maintained for the purposes of representing OIG and its components in court cases and administrative proceedings, in accordance with the Inspector General Act of 1978 (5 U.S.C. App.).
Medicare and State Health Care Programs: Fraud and Abuse; Issuance of Advisory Opinions by OIG
In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996, this final rule amends the OIG regulations at 42 CFR part 1008 by (1) revising the process for advisory opinion requestors to submit payments for advisory opinion costs, and (2) clarifying that notices to the public announcing procedures for processing advisory opinion requests will be published on OIG's Web site.
Privacy Act of 1974; Revisions to OIG's Privacy Act System of Records: Criminal Investigative Files
The Office of Inspector General (OIG) proposes to revise and update the existing system of records, entitled ``Criminal Investigative Files'' (09-90-0003). This proposed notice is in accordance with the Privacy Act requirement that agencies publish their amended systems of records in the Federal Register when there is a revision, change, or addition. This system of records, maintained by OIG, was last revised and updated on December 8, 2006.
Solicitation of Information and Recommendations for Revising the Compliance Program Guidance for Nursing Facilities
This Federal Register notice seeks the input and recommendations of interested parties as OIG revises the compliance program guidance (CPG) for nursing facilities, especially those serving Medicare, Medicaid, and other Federal health care program beneficiaries. The nursing home industry has experienced a number of changes since OIG first published a CPG in this area (65 FR 14289; March 16, 2000). Additionally, the subsequent years of enforcement and compliance activity in the nursing home industry has allowed OIG to address more fully the various risk areas in nursing home compliance. In evaluating the contents of the nursing facility CPG, OIG is soliciting comments, recommendations, and other suggestions from concerned parties and organizations on how best to revise the nursing facility CPG to address relevant compliance issues. Specifically, OIG seeks comments addressing any changes to existing risk areas and introducing any new risk areas.
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.
Medicare and State Health Care Programs: Fraud and Abuse; Safe Harbor for Federally Qualified Health Centers Arrangements Under the Anti-Kickback Statute
In accordance with section 431 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), this final rule sets forth a safe harbor under the anti-kickback statute to protect certain arrangements involving 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. 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.
Medicare and State Health Care Programs: Fraud and Abuse; Clarification of Terms and Application of Program Exclusion Authority for Submitting Claims Containing Excessive Charges
On September 15, 2003, we published a notice of proposed rulemaking (68 FR 53939) soliciting public comments regarding further guidance on OIG's exclusion authority under section 1128(b)(6)(A) of the Social Security Act and 42 CFR 1001.701 of our regulations. Having considered the public comments and for the reasons explained below, we are not promulgating a final rule.
Healthcare Integrity and Protection Data Bank: Announcement of Proactive Disclosure Service Opening Date and User Fees
The Office of Inspector General (OIG) is announcing the availability of a Proactive Disclosure Service (PDS) Prototype for customers of the Healthcare Integrity and Protection Data Bank (HIPDB). The PDS was developed for the National Practitioner Data Bank (NPDB) in response to customers' interest in real-time monitoring of practitioner credentials. As a result of the technical interoperability of the NPDB and HIPDB, the PDS feature is also being made available to HIPDB customers.
Program Exclusions: Correction
The HHS Office of Inspector General Published a document in the Federal Register of October 18, 2006, imposed exclusions. The document contained the incorrect monthly exclusions.
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.
Privacy Act of 1974; Revisions to OIG's Privacy Act System of Records-Criminal Investigative Files
The Office of Inspector General (OIG) is revising the existing system of records, entitled ``Criminal Investigative Files'' (09-90- 0003), by updating the ``Systems Location'' section of that document, and republishing the revised system of records in its entirety. This notice is in accordance with the Privacy Act requirement that agencies publish their amended systems of records in the Federal Register when there is a revision, change, or addition. This system of records, maintained by OIG, was last revised and updated on June 19, 2003 (68 FR 36828).
Publication of OIG's Guidelines for Evaluating State False Claims Acts
Under section 1909 of the Social Security Act (the Act), 42 U.S.C. 1396h, the Inspector General of the Department of Health and Human Services is required to determine, in consultation with the Attorney General, whether a State has in effect a law relating to false or fraudulent claims submitted to a State Medicaid program that meets certain enumerated requirements. If the Inspector General determines that a State law meets these requirements, the State medical assistance percentage, with respect to any amounts recovered under a State action brought under such a law, shall be increased by 10 percentage points. This notice sets forth the Inspector General's guidelines for evaluating whether a State law meets the requirements of section 1909 of the Act.
Medicare and State Health Care Programs: Fraud and Abuse; Safe Harbors for Certain Electronic Prescribing and Electronic Health Records 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 final rule establishes 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 information. In addition, in accordance with section 1128B(b)(3)(E) of the Social Security Act (the Act), this final rule creates a separate new safe harbor for certain arrangements involving the provision of nonmonetary remuneration in the form of electronic health records software or information technology and training services necessary and used predominantly to create, maintain, transmit, or receive electronic health records.
Healthcare Integrity and Protection Data Bank: Change in User Fees
In accordance with final regulations at 45 CFR part 61, implementing the Healthcare Integrity and Protection Data Bank (HIPDB), the Department is authorized to assess a fee on all requests for information, except requests from Federal agencies. In accordance with Sec. 61.13 of the HIPDB regulations, the Department is announcing an adjustment from $4.25 to $4.75 in the fee charged for each query submitted by authorized entities. There will be no change to the current $8 self-query fee.
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.
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.
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