Office of Inspector General 2013 – Federal Register Recent Federal Regulation Documents

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).